A1:

During its routine inspection of Biomedical Services Headquarters, the FDA identified issues that fell into the following categories: donor suitability, labeling of blood, quality assurance, information technology and hotline cases. These issues are called observations, or examples in areas the FDA views as needing improvement.

Q2:   What specifically does the American Red Cross do to ensure that it is collecting and distributing safe blood?

A2:

Each blood donation collected by the American Red Cross meets numerous safety and quality requirements. Our extensive screening processes must include:
• Conducting at least nine tests of each donation to screen for diseases including AIDS/HIV, hepatitis, syphilis and leukemia
• Rejecting and destroying units from ineligible donors
• Screening for high-risk behaviors that can lead to disease transmission
• Using only volunteer donors
• Educating the public about transmissible diseases and high-risk behaviors that can lead to disease transmission
• Maintaining donor database that prevents tainted blood from being used in the future.

Q3:   Did any patients get sick or die because of blood products distributed by the Red Cross?

A3:

• The FDA and Red Cross agree the blood supply has never been safer.
• Multiple layers of safety throughout the Red Cross system are aimed at ensuring patient safety.
• From the moment a potential blood donor walks into a Red Cross donor center until the donation is shipped to a hospital, our staff performs hundreds of steps to safeguard the blood supply. These include completion of the blood donation record, health history screening, confidential unit exclusion, testing and post donation information.

Q4:   The FDA inspection report reveals the largest number of violations in your history. Given this, how can you say that the blood supply is safe?

A4:

• Both the Red Cross and the FDA agree the blood supply today is safer than ever before. So it's safe to donate blood, and when it comes to receiving a transfusion, the FDA has said that hospital patients who require blood transfusions should not hesitate to receive them.
• While this recent inspection noted a number of observations, the observations in field units that are responsible for collecting, processing, testing, and distributing blood products have maintained a downward trend. In fiscal year 2002, 27 of 38 regional sites and laboratories inspected by the FDA had zero observations. In the facilities where observations were written, 7 of the 11 facilities had no more than three observations.

Q5:   What are your plans for improvement and meeting regulatory requirements?

A5:

The Red Cross has initiated a long-term plan with nearly 40 programs that utilize best practices, enhance operational effectiveness and improve redundant checks. These programs cover nearly all functions and departments within Biomedical Services Headquarters. They include:
• Using new technologies to reduce the potential for human error
• Restructuring and increasing the level of Quality Assurance staffing by 50 percent, with 175 new positions being added throughout the field units and Headquarters
• Creating a less cumbersome and complex training system and implementing a training program like those found in other successful corporations
• Re-engineering the core manufacturing processes to provide more robust, easier to follow processes that reduce and prevent errors
• Investing in facilities to address short-term infrastructure needs and enable more efficient and effective adoption of new technology.

Q6:   How have your local field units done with their inspections?

A6:

FDA observations of Red Cross have maintained a positive downward trend during the past several years. In fiscal year 2002, 27 of 38 regional sites and laboratories inspected by the FDA had zero observations. In the facilities where observations were written, 7 of the 11 facilities had no more than three observations.