College of American Pathologists
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  Biovigilance network advancing slowly—but it’s progress


CAP Today




October 2011
Feature Story

Karen L. Wagner

The U.S. Biovigilance Network didn’t leap out of the starting gate. Instead, it’s been moving at a slow but steady pace. Read into that what you will—but we all know how it worked for the turtle.

Gathering data to develop recommendations for increasing the safety of blood donations and transfusions, as well as organ, cell, and tissue transplants, is taking longer than expected, says Barbee Whitaker, PhD, director of the AABB’s Center for Data and Special Programs and its Patient and Donor Safety Center. “However,” she says, “hospitals and blood banks are beginning to explore the opportunities for involvement in hemovigilance,” the surveillance of adverse events associated with blood collection and transfusion.

Initiated in 2006, the U.S. Biovigilance Network was developed to provide hospitals and other health care facilities with early warnings of transfusion and transplant safety issues. It is also intended to promote the exchange of information about such safety issues and identify applications and educational activities that lead to safer and more efficacious transfusion, blood collection, and transplantation. The network is a public/private collaboration of the Centers for Disease Control and Prevention, AABB, and numerous other stakeholders.

As a first step in creating the biovigilance network, the CDC funded and developed a hemovigilance module, which operates via the agency’s National Healthcare Safety Network, or NHSN, a Web-based patient safety surveillance system that monitors health care-associated infections. The online hemovigilance module is being used to gather data from hospitals about adverse events associated with blood transfusion. The AABB plans to analyze the data to develop practice guidelines and standards to improve patient care, Dr. Whitaker says.

Nine hospitals from across the country participated in a year-long pilot of the hemovigilance module in 2009. The CDC officially launched the module in 2010, opening it to all entities involved in blood transfusion, which represents about 5,000 facilities, according to Matthew J. Kuehnert, MD, director of the CDC’s Office of Blood, Organ, and Other Tissue Safety. About 100 hospitals have signed up to use the hemovigilance module, and about one-third of them are actively reporting data on errors and accidents and using the system regularly, according to data from the CDC.

“Honestly, we [the AABB] would prefer greater participation, but it’s early yet,” Dr. Whitaker says, noting some likely reasons for the program’s rate of progress. “It requires adopting standard definitions, which may lead to some changes to policies and procedures within the hospital transfusion service. At a time when there are many critical priorities, we’re really pleased that we have a group that is actively participating and enthusiastic about patient safety.”

Users must also complete a transfusion-related survey that includes questions on annual transfusion rates and other facility statistics, as well as determine how to input data and train transfusion staff on the system. The details entered on the survey allow hospitals to compare themselves with other, similar hospitals, Dr. Whitaker explains.

Furthermore, hospital and blood bank employees must enter data on transfusion reactions, violations of standard procedures, and other incidents into the hemovigilance module. However, the CDC is developing data architecture that software developers can use to build hemovigilance capability into their own systems. This would make it easier to transfer data between users’ blood bank or other information systems and the NHSN, Dr. Kuehnert says. A pilot test of such interfaces is scheduled to kick off in fall 2012, he adds.

Although it’s too early to assess successes, Dr. Whitaker says, one participant in the year-long hemovigilance pilot was able to identify and eliminate a potential threat to patient safety using the hemovigilance module. Because the module allows users to track and trend internal events and compare their own data to those of facilities of a similar size or within the same region, the health care system discovered a trend in which patients were being assigned blood products not intended for them, and it was able to rectify the situation.

University Hospitals Case Medical Center, a 1,032-bed tertiary care medical center in Cleveland, is another participant that began reporting adverse events during the pilot. Participating in the pilot helped the teaching institution educate residents and fellows about adverse reactions. It also helped attending physicians develop a more standardized approach to classifying and categorizing reactions, says Katharine A. Downes, MD, the medical center’s associate medical director of blood banking and transfusion medicine. “We’re defining our transfusion reaction interpretations in a more uniform way,” particularly with transfusion-associated circulatory overload, she says.

One of the benefits of participation, says Dr. Downes, is that users can conduct customized internal queries on data. For example, a person can use the system to create a graph showing the number of transfusion reactions by component over a defined period of time, she says, adding that such data can be used for quality assurance reporting. “The system also captures the severity of the transfusion reaction and patient outcome,” Dr. Downes adds.

A year from now, after the module generates more data, the CDC will issue a report on its findings, including such information as the rate of each adverse event, Dr. Kuehnert says. This will allow facilities to benchmark their rates to the averages.

“What we anticipate is, with time, there will be an annual report on the data that’s been collected, and AABB will also do data analysis that is more focused on specific interventions that are of interest to AABB members,” Dr. Kuehnert says.

“One of the things we think is really important,” he adds, “is that even if you’re not using the system, if you adopt all the definitions, then when the annual reports come out you can compare yourself to the rates and benchmarks that are set in those reports.”

In addition to transfusion surveillance, blood donor adverse reaction surveillance is a key component of hemovigilance.

The Department of Health and Human Services, AABB, and other stakeholders recently joined to set up a donor hemovigilance module for tracking adverse donor reactions. Development of the module has been funded by the Department of Health and Human Services.

Three blood centers—one large, one medium, and one small—are participating in a pilot test of the system, but approximately 15 facilities have signed up to participate, Dr. Whitaker says. “We are hoping to open it up to all blood centers later this year,” she adds.

Dr. Downes, who serves as chair of the CAP Transfusion Medicine Resource Committee, says involvement in the country’s first biovigilance initiative has given pathologists yet another opportunity to contribute to a project that is important to health care institutions and patients. The ultimate goal of the network, to improve patient safety, aligns with the College’s multi-year initiative to transform pathology by promoting the role of the pathologist as a critical member of the patient care team, she says.

“This really plays into the whole transformation initiative because it involves direct patient care,” Dr. Downes says. “I think it’s exciting.”

Karen Wagner is a writer in Forest Lake, Ill.