American Red Cross Safety Actions

When fewer than 10 cases of AIDS that appeared to be associated with blood and blood products had been reported, the Red Cross expanded health history interviews to include specific questions to alert and defer potential donors with symptoms suggesting AIDS or with histories of exposure to persons with AIDS. To this day the Red Cross continues to update its donor criteria to screen for risks related to AIDS and other diseases.

Red Cross Blood Services regions began implementing donor screening recommendations proposed by the Centers for Disease Control to identify donors at potential risk for transmitting the AIDS virus.

Immediately after the FDA licensed the first test to detect the antibody to HIV, Red Cross Blood Services regions began testing all newly donated blood.

Red Cross voluntarily initiated a "look back" procedure. In cooperation with hospitals, the Red Cross notified recipients of blood transfusions donated by individuals who, on a later donation, were found to have a positive test for HIV antibodies. This helped determine whether the recipients had been exposed to potentially infected blood.

Red Cross Blood Services regions implemented a surrogate test (ALT, alanine aminotransferase) for non-A, non-B hepatitis, exceeding FDA requirements.

Red Cross Blood Services regions implemented a second surrogate test for non-A, non-B hepatitis known as anti-HBc, or Core.

Red Cross recommended that patients who received blood transfusions before HIV testing began in 1985, discuss with their physicians the advisability of undergoing testing.

Red Cross Blood Services regions implemented HTLV-I antibody test for human T-lymphotropic virus type I. There have been no reports in the United States of HTLV-I transmission resulting from a blood transfusion. However, because of the seriousness of the disease, Red Cross requested development and FDA licensure of a test to detect HTLV-I infection.

Red Cross Blood Services regions implemented testing for HCV, previously known as non-A, non-B hepatitis C virus. This new test was considered a significant breakthrough because HCV is the most common cause of transfusion transmitted viral infection in the United States.

Red Cross restructured its Blood Services to centralize authority, to standardize procedures and to improve quality assurance. In addition, Red Cross standardized its Blood Services training programs, updated its computer systems and established a crisis resolution plan to ensure the implementation of corrective action to ensure compliance with FDA procedures.

Red Cross President Elizabeth H. Dole announced a multi-year program to streamline operations of Red Cross Blood Services. The transformation plan would establish a new management structure; consolidate the number of testing laboratories to nine state-of-the-art testing centers, offering the best in transfusion related services to any hospital served by the Red Cross; standardize operating procedures and training; replace 28 existing computer systems with a single state-of-the-art system; and enhance service delivery.

Red Cross began using a new test that detected antibodies for both HIV-1 and HIV-2.

Red Cross began using a new, more sensitive test to detect hepatitis C virus (HCV) antibody, called HCV 2.0.

Nine National Testing Laboratories began operation in Dedham, MA; Philadelphia, PA; Charlotte, NC; Atlanta, GA; Detroit, MI; St. Louis, MO; Tulsa, OK; St. Paul, MN and Portland, OR. The labs follow identical testing procedures, use the same state-of-the art equipment and are designed the same to simplify standardization and enable quick adoption of technological changes and new regulatory requirements.

The FDA accepted the Red Cross plan to create autonomous quality assurance units within each Blood Services region. These units conduct periodic reviews of regional procedures which are then reported to National Red Cross Headquarters.

Within 24 hours after the FDA licensed the test to detect the antigen to HIV, Red Cross Blood Services regions began testing all newly donated blood.

The Blood Products Advisory Committee (BPAC) of the FDA recommended universal leukocyte reduction of cellular blood components in the US. The BPAC committee unanimously agreed that the "benefit-to-risk ratio associated with leukoreduction is sufficiently great to justify requiring the universal leukoreduction of all non-leukocyte cellular transfusion blood components." The committee, however, suggested no time limits or mechanisms for conducting or implementing universal leukocyte reduction. The Red Cross has moved to implement universal leukoreduction and currently more than 77 percent of the Red Cross’s red blood cells are leukoreduced.

The Red Cross added yet another layer of safety to the blood supply by implemented Nucleic Acid Testing (NAT) as part of a U.S. Food and Drug Administration Investigational New Drug (IND) protocol. NAT uses a new form of testing technology that can directly detect the genetic material of transfusion transmitted viruses, such as HIV, the virus that causes AIDS, and hepatitis C (HCV). Nucleic Acid Testing (NAT) is expected to substantially reduce the "window period" for hepatitis C virus (HCV) and to have a modest effect on the window period for HIV.