The American Red Cross is passionately committed to the safety of our donors, our patients and the public we serve. We provide safe blood and blood products whenever and wherever needed; and are dedicated to discovering and implementing ever better ways to improve the safety of the blood supply through research and technological advances.

WHAT WE ARE DOING
We want to assure our patients, our donors and the American public that the blood supply is safe. Moreover, it is safer than it has ever been. Any inappropriate releases are rare events; regardless of the number, they will not be tolerated.

As a result of our efforts and the many safety checks in place, no patient has been harmed by blood that has been inappropriately released. Blood banking is a uniquely humanitarian enterprise started by the American Red Cross shortly after World War II. Blood has become a cornerstone of medicine. Modern medicine cannot be practiced without safe and available blood.

The blood supply in America is entrusted to non-profit organizations including the Red Cross and independent blood centers. The enterprise relies on millions of volunteer donors who give a piece of themselves through blood donations - a precious raw material - to save another. Blood services require elaborate and highly technological screening, processing, testing, transporting and monitoring. All of our nation's blood centers face major financial, regulatory and operating challenges, which we are all responding to on an immediate and ongoing basis. Since 1991, the American Red Cross has made enormous investments in blood safety and availability:

• Converting from a patchwork of 54 local cottage industry blood banks into a single blood services enterprise to improve safety, increase efficiencies, standardize performance and establish accountability.
• Building eight state-of-the-art National Testing Labs where we perform increasingly sophisticated tests to ensure blood safety.
• Developing a single national computer system for databasing donor records, blood products tracking and labeling, clinical evaluations, constant quality assessment and monitoring the nation's blood inventory on a daily basis.
• Establishing a nationally standardized quality assurance program with several layers of safety.

THERE IS MORE TO DO
We are now investing further to reengineer our entire enterprise including:

• Focusing on the recruitment, training and retention of our employees. People are the key to ensuring quality. We are bolstering our talent in this humanitarian enterprise, strengthening management, financial and medical expertise.
• Restructuring our quality systems to more fully integrate system-wide accountability and to reduce errors, with a continual focus on patient and donor well being. This effort will include the ongoing use of third party auditors to ensure regulatory compliance.
• Generating financial resources to create the blood centers of tomorrow. We will seek philanthropic dollars to protect this national treasure, assure fair pricing to make the enterprise financially sustainable for the long term and enhance operating efficiencies and productivity while ensuring quality.
• Upgrading and, as appropriate, streamlining our processing facilities and donation sites.
• Improving our computer systems and functions.
• Implementing new technologies to make blood safer such as universal leukoreduction to reduce adverse reactions and Nucleic Acid Testing for more sensitive detection of HIV and Hepatitis C.
• Energizing and recruiting a new generation of blood donors to reduce the gap between the need for blood and the supply.
• Enhancing investment in research and development at our Holland Laboratory geared toward understanding and eradicating future threats to the human blood supply.
• Committing an additional $100 million of debt to ensure that financial resources do not limit our ability to move quickly on these development efforts.

In 1993, the American Red Cross and the FDA entered into an agreement under court jurisdiction called a Consent Decree because of persistent regulatory issues.

On April 11, 2003, the Red Cross and the Food and Drug Administration (FDA) reached agreement on terms of a new Consent Decree, which provides legal guidance on the handling of donated blood. Both organizations have agreed to work collaboratively to further enhance the safety of America's blood supply under this new agreement.

This agreement is welcomed and marks a new era of cooperation between the Red Cross and the FDA, allowing focus and forward progress to enhance operations. The Red Cross and the FDA agree that the nation's blood supply is safer today that it has ever been. We are determined to keep it as safe as possible and organizationally to be accountable to the highest standards set by regulators and the American public we serve.

There is a recognized need to further strengthen our procedures and processes. The Red Cross has implemented a comprehensive and aggressive quality program that will result in an even safer blood supply.

The new Consent Decree provides greater specifics on how the Red Cross will manage, monitor and resolve problems if they arise. It formalizes management of issues and provides timelines for their resolution. It calls for fines if the Red Cross fails to meet compliance standards. If that occurs, no public financial donations will be used to pay for these assessments. Previously debated issues between both organizations have been resolved with no further action being taken.

The American Red Cross remains dedicated to its mission and to the millions of Americans each year who rely on us to provide lifesaving blood and blood components. We want the American people to understand that giving blood is safe and, if they need blood, they should not hesitate to receive it.

Someone in the United States needs a blood transfusion every two seconds. Anyone who is 17 or older, weighs 110 pounds or more and is in general good health is encouraged to call 1-800-GIVE-LIFE to schedule a blood donation appointment.

Together, we can save a life.

Blood Safety