"Hemovigilance" is a new word recently making its way into the American healthcare lexicon. Although many European countries have had hemovigilance programs for at least 10 years, they are just recently starting to be implemented in U.S., said Barbee Whitaker, PhD, director, Data and Special Programs, AABB (formerly the American Association of Blood Banks).

"Hemovigilance is detection, gathering and analysis about unexpected adverse events associated with blood collection and transfusion," she explained.

Dr. Whitaker and others hope nationwide hemovigilance programs, including ones run by the CDC with support from AABB, and the American Red Cross (ARC) program, will help reduce the number of adverse events and medical errors during the blood transfusion process, starting from blood donations all the way to post-transfusion.

Creating a Program

Hemovigilance comes under the umbrella of biovigilance, a term associated with any clinical use of what is considered a biologic source-blood, tissue and organs, noted Anne Eder, MD, PhD, executive medical director, ARC.

Both Drs. Eder and Whitaker agree hemovigilance has been around in the U.S. all along, just without a national program. "We have had sufficient and talented research in the concept, but it wasn't called hemovigilance or it wasn't organized on the national level before," Dr. Eder added.

Most hospitals have reporting requirements for different kinds of events dealing with blood donation and transfusion, creating a "patchwork" hemovigilance concept, Dr. Whitaker mentioned. She noted AABB has been facilitating an effort to create a national hemovigilance program involving government and nongovernment agencies since 2006 when the AABB Interorganizational Task Force on Biovigilance was formed.

The Task Force consists of key stakeholders in the transfusion and cellular therapies communities, including representatives from blood collection centers, hospitals, the federal government, experts on data collection and experienced individuals from other countries with hemovigilance systems.

In February, the CDC, with support of the AABB Task Force, launched the Hemovigilance Module of the National Healthcare Safety Network, or NHSN, providing all U.S. hospitals transfusing blood and blood components the opportunity to enroll and contribute data on adverse events associated with blood transfusions. The hope for this program and others is healthcare professionals will identify trends within their individual hospitals and on a national level so best practices can be reviewed and improved.

"Among the advantages of having this now is everyone will be using the same definitions with regards to the adverse events we will be tracking," Dr. Whitaker told ADVANCE. "You have a common place to report those definitions and events, and you can start to see trends happening beyond your hospital. The transfusion medicine community can learn from the experiences of others."

The CDC hemovigilance reporting module was developed by CDC with expertise contributed from the private sector transfusion medicine community through a collaborative effort spearheaded by the AABB Task Force (see Sidebars for goals and components).

Saving Lives

In 2005, the ARC started its own hemovigilance program (see Sidebar for program goals). The program especially looked at transfusion reactions such as transfusion-related acute lung injury (TRALI)-the leading cause of morbidity and mortality associated with blood component therapy-and sepsis from bacterially contaminated platelet components. Since the program started, preventive measures have been taken to reduce these events, Dr. Eder said.

One interesting finding has greatly helped the safety of patients. Through their observation and data reported from other countries, the ARC Hemovigilance Program members noted many TRALI cases were caused by plasma transfusion linked to a female donor.

"TRALI may be caused by HLA antibodies, and women form these during pregnancies," Dr. Eder explained. "Recognizing this association, ARC decided to distribute plasma preferentially from male donors for transfusion."

Since 2007, 95 percent of plasma used for blood transfusions in the 3,000 hospitals nationwide the ARC provides blood products to has been from male donors. Since the ARC Hemovigilance Program made this switch, there has been an 80 percent reduction in the number of TRALI reports attributed to plasma transfusion, and no fatalities in the years after implementing the change.

The Whole Process

What is unique about hemovigilance programs is they span over a wide timeline-from the time a donor gives blood until after a patient receives a transfusion. Adverse reactions can happen at any time in the donation/transfusion continuum. For example, a donor feeling faint after she donates 525 ML of blood is an adverse reaction.

"Blood donation is a safe procedure," Dr. Eder reassured. "Most people do fine and don't experience any symptoms. But especially with whole blood donations, there can be some dizziness. More serious symptoms can occur, like fainting, but that happens less often."

Notably, though, reactions are more likely to occur among young donors; reaction rates are higher among 16- and 17-year-olds than older donors, Dr. Eder noted.

Because of tracking and reporting in hemovigilance programs, healthcare professionals can become more proactive about potential adverse reactions once they are identified. For example, young donors are targeted to receive focused pre-donation education, and the ARC introduced new height and weight selection criteria for donors under the age of 19, Dr. Eder said. After this was done, the ARC saw a significant reduction in reaction rates among young donors.

Adverse reactions can also occur on the transfusion end. A blood transfusion patient with a mild fever is considered to be one potential adverse reaction; they don't have to be more serious events, such as TRALI, to be reported, Dr. Whitaker said. However, other serious reactions, such as a patient receiving the wrong unit of blood, do need to be reported.

Amanda Koehler (akoehler@advanceweb.com) is associate editor of ADVANCE.

Key Terms in Hemovigilance Adverse Event Reporting

• Adverse incident-An accident or error that could lead to an adverse outcome affecting a) the safety, efficacy or quality of blood, blood components or plasma derivatives; or b) the safety of recipients.

• Accident-An unexpected or unplanned event, not attributable to deviation from standard operating procedures.

• Error-An unexpected, unplanned deviation from standard operating procedure likely attributable to a human or system problem.

• High priority incident-An accident or error that has high potential for wrongful transfusion in a recipient. This would include sample labeling errors; collecting a sample from the wrong patient; or processing needs not indicated, not done, misunderstood or misinterpreted.

• Near miss-An incident discovered before the start of the transfusion and could have led to a wrongful transfusion or reaction in a recipient.

-NHSN

ARC Hemovigilance Program Goals

• mprove safety for recipients of blood components;

• minimize procedure risk for blood donors;

• identify significant trends emerging from analysis of reports of uncommon events;

• identify strategies to reduce the risk of complications in susceptible patient and donor groups; and

• monitor the effectiveness of the interventions introduced to improve donation and transfusion safety.

-ARC

Future Biovigilance Components

In addition to the recipient hemovigilance module described in this article, future plans include specialized Web-based systems to track:

• adverse reactions associated with blood donors;

• tissue and organ transplantation; and

• adverse events associated with evolving cellular therapies.

-AABB

Transfusion Medicine Community Goals

Major anticipated outcomes include:

• improving patient outcomes and donor health;

• reducing risk for adverse events in hospitals, collection centers and others participating in transfusion and transplantation;

• reducing costs of transfusion and transplantation by eliminating errors and inefficiencies where possible;

• improving the policies, processes and procedures for transfusing blood and transplanting tissue, organs and cellular products;

• identifying threats adversely affecting patients and donors and designing interventions to mitigate them;

• continuously improving quality for participating facilities through benchmarking; and

• developing evidence-based responses to support community efforts addressing public health concerns of the federal government.

-AABB