RECIPIENT SYSTEM

Initial Data on Adverse Events Gathered Through Recipient Hemovigilance Module

The recipient hemovigilance module of the U.S. Biovigilance Network has successfully gathered data for approximately 764 adverse reactions and incidents since its launch in May. Seven hospitals currently are contributing to the system, while the other two are expected to begin submitting data soon. This system — part of the Centers for Disease Control and Prevention’s National Healthcare Safety Network, a secure, voluntary, Internet-based surveillance system — enables the collection and analysis of data on the blood transfusion process to identify trends and recommend best practices to reduce adverse reactions and incidents.

CDC Begins Dialogue to Facilitate Electronic Interface with Recipient Hemovigilance System

The Centers for Disease Control and Prevention has begun a dialogue with software vendors to help facilitate the development of electronic interfaces with the National Healthcare Safety Network hemovigilance module. During an initial conference call with four vendors held in July, information was shared regarding the specifications required to upload data from hospital software systems to CDC’s NHSN through an electronic interface. Companies will have additional opportunities for face-to-face meetings this fall, including at the HL7 conference in September and the AABB Annual Meeting and TXPO, which will be held Oct. 24-27 in New Orleans. These information exchanges also enable software developers to ask other questions about the recipient hemovigilance system.

AABB and AHRQ Collaborate on Common Formats for Blood-Related Adverse Events

AABB and the Agency for Healthcare Research and Quality have collaborated on the data elements to be included for blood-related adverse events in the agency’s patient safety organization common formats. Representatives from AABB and AHRQ met in June to ensure the common formats — which will contain a standardized language and data elements for reporting patient safety data — are compatible with those used as part of the recipient hemovigilance module of the U.S. Biovigilance Network. This collaboration will ensure that data collected through the recipient hemovigilance module are comparable with patient safety information gathered by patient safety organizations, and will set a national standard of adverse events and incidents related to blood transfusions. It also will allow software companies to develop platforms that correspond with the AHRQ common formats and the U.S. Biovigilance Network common definitions. AHRQ is expected to release an updated version of the common formats in September.

The definitions included in the Centers for Disease Control and Prevention’s National Healthcare Safety Network hemovigilance module were developed by the AABB Hemovigilance System Working Group and CDC to be consistent with ISBT and those used within the MERS-TM and Canadian hemovigilance systems.

DONOR SYSTEM

Data Entry Begins for Donor Hemovigilance System Pilot

The pilot of the donor hemovigilance module of the U.S. Biovigilance Network, which began as beta testing earlier this year, expanded in July to include real-time data entry. Members of the Donor Hemovigilance System Working Group are overseeing this pilot to ensure that the system functions properly. Some participants are also following instructions outlined in the interface control document to develop interface files that allow data to be uploaded directly to the system. In addition, these centers have incorporated the definitions for each field and the standard definitions for donor-related adverse reactions into their standard operating procedures. These standards — developed by the working group — will facilitate the smooth exchange of data with the national system. The donor hemovigilance system will collect data on blood donors with the goal of identifying trends, recommending best practices and designing interventions to reduce adverse reactions associated with blood donation.

U.S. BIOVIGILANCE NETWORK

Preparations for Nationwide Enrollment in U.S. Biovigilance Network Collaborative to Begin This Fall

Facilities interested in joining the recipient hemovigilance module, available through the Centers for Disease Control and Prevention’s National Healthcare Safety Network, may begin preparing and taking steps toward enrollment as early as this fall. Once approved, at least 50 additional facilities, representing 15 percent of the Red Blood Cells transfused in the United States, have committed to begin collecting data for the recipient hemovigilance system, while the donor hemovigilance module of the network will represent a majority of the blood collection facilities in the United States when implemented nationally. Facilities are encouraged to contact the Center for Data and Special Programs if interested in contributing data or financial support to the network. A full list of committed participants and financial supporters of the network can be found on the U.S. Biovigilance Network Web page.

Resources Available to Help Hospitals, Blood Centers Prepare for Nationwide Launch of U.S. Biovigilance Network

While the pilots of the recipient and donor hemovigilance portions of the U.S. Biovigilance Network are under way, a number of resources are available to help hospitals and donor centers prepare to join once the systems launch nationwide. Future participants in the recipient hemovigilance module are encouraged to implement the system protocol. In addition, staff may be trained to interpret adverse reactions based on the common definitions and begin rewriting procedures to be consistent with those outlined in the protocol. Donor centers interested in joining the donor hemovigilance module are encouraged to review the interface control document and begin development of interface files that will allow the direct upload of data. These centers also may implement the common definitions and terms for donor-related adverse reactions outlined in the document. These steps will help ease the transition for those organizations interested in participating and will facilitate the exchange of data with the U.S. Biovigilance Network.

RECENT ACTIVITY

House Panel Expresses Support for Hemovigilance

The House Appropriations Committee has expressed its support for the hemovigilance module of the Centers for Disease Control and Prevention's National Healthcare Safety Network. According to a report that accompanied the Labor, Health and Human Services and Education 2010 appropriations bill, which the committee passed on July 17 and the full House of Representatives approved on July 24, “The Committee encourages CDC to move forward in implementing the transfusion data network, in collaboration with private sector experts to maximize hospital participation, adequately train staff, analyze data, and develop effective interventions.” AABB continues to advocate for federal support for the U.S. Biovigilance Network. The hemovigilance module, a component of that network, will be used to collect, analyze and report national data on adverse events and medical errors occurring during blood transfusions.

ON THE ROAD

AABB Annual Meeting Puts Spotlight on U.S. Biovigilance Network

The U.S. Biovigilance Network will be highlighted throughout the 2009 AABB Annual Meeting and TXPO. Multiple educational sessions will provide information about the network, including an update on the first 100 days of the pilot of the recipient hemovigilance module and highlights of the donor hemovigilance system. “The U.S. Biovigilance Network: Biovigilance 101” will include an overview of biovigilance efforts within the United States, and “Global Efforts to Improve Biovigilance: Cell, Tissue and Organ Safety” will highlight international biovigilance activity involving other biological products such as tissue. Software vendors also will be able to attend a forum with representatives from the Centers for Disease Control and Prevention to discuss technical requirements of the National Healthcare Safety Network hemovigilance module. In addition, the CDC will have a booth within the TXPO to demonstrate the recipient hemovigilance module and to interact with potential participants.

Hemovigilance Software Demonstrations to Be Held in Biovigilance Pavilion

Live demonstrations of the recipient and donor hemovigilance modules of the U.S. Biovigilance Network will be held in the Biovigilance Pavilion at the 2009 AABB Annual Meeting and TXPO. The pavilion, which will be located in the Member Action Center, will give attendees an opportunity to learn how data is entered into the network, view the system requirements and discuss the adverse event definitions. Visitors to the pavilion also will be able to ask questions of experts and view presentations on how to become involved by either contributing data or providing financial support. In the meantime, interested facilities with questions about the system are encouraged to review the U.S. Biovigilance Network FAQs or contact AABB’s Center for Data and Special Programs.

Baltimore, DC to Host Biovigilance Recruitment Meetings This Fall

Baltimore and Washington, D.C., will be the next sites hosting regional recruitment meetings to discuss the U.S. Biovigilance Network. Participants will have the opportunity to see presentations of the donor and recipient hemovigilance portions of the network and ask questions regarding participation, data entry and software interface requirements. In addition, AABB CEO Karen Shoos Lipton, JD, will explain why AABB is committed to the project and how these efforts will help improve patient and donor safety. The Baltimore meeting is scheduled for Sept. 22 at the offices of Womble Carlyle, while the Washington, D.C., meeting will be held later in the fall at the AABB national office in Bethesda, Md. Individuals interested in attending either meeting are encouraged to contact the Center for Data and Special Programs.

IN THE NEWS

U.S. Biovigilance Network Continues to Receive Media Attention

The U.S. Biovigilance Network continues to receive media attention from national and regional newspapers. In July, the Albany Herald announced that Phoebe Putney Memorial Hospital in Albany, Ga., is participating in the pilot of the recipient hemovigilance module of the network. The article notes that until now there has never been a central location for reporting adverse events associated with a blood transfusion and that the system will help improve patient safety while making transfusion safety a top priority in hospitals. Although sites piloting the Centers for Disease Control and Prevention’s National Healthcare Safety Network hemovigilance module may choose to publicize their identity, participation is confidential.