RECIPIENT SYSTEM

Hospitals Encouraged to Take Preliminary Steps Now to Join Hemovigilance Module in January

Hospitals are encouraged to take preliminary steps now — including training and education — so that when enrollment for the hemovigilance module of the Centers for Disease Control and Prevention’s National Healthcare Safety Network opens in January they are able to immediately join and begin benefiting from the system. The module, which was developed through the efforts of the U.S. Biovigilance Network, is a surveillance system for tracking adverse events associated with transfusion. AABB has posted on its Web site a checklist detailing steps hospitals can take between now and the launch, at which point the hemovigilance module will be open for full enrollment and data entry.

CDC Making Way for Hospital Systems to Electronically Interface With Hemovigilance Module

CDC is working with software vendors to develop an interface that would enable facilities to electronically submit data to the hemovigilance module of the National Healthcare Safety Network. The interface would use a Health Level Seven data structure called the “Clinical Document Architecture” that facilitates the electronic exchange of data between different software systems. CDC has been meeting with multiple vendors to discuss the creation of the interface, which will help a hospital reduce the time spent entering data and also reduce the opportunity for data-entry error. Other software vendors interested in joining talks on the development of the interface should contact AABB’s Center for Data and Special Programs and CDC.

Biovigilance Audioconference Offers Training for CDC’s National Healthcare Safety Network

A Dec. 2 audioconference hosted by AABB will cover incidents and near-miss events that will be captured in CDC’s National Healthcare Safety Network hemovigilance module. Presenters will discuss how to categorize a near miss or incident for entry into NHSN and offer examples of how to apply incident criteria to actual events, including wrong blood in tube, sampling errors and special processing errors. The audioconference is offered at no charge. Those interested can register on the AABB Web site.

DONOR SYSTEM

Donor Hemovigilance System Checklist and User Manual Available

The participation checklist and user manual for the donor hemovigilance system are now available on the AABB Web site. The checklist details the steps blood centers need to take to join the system, which will launch March 15, 2010. The user manual provides instructions for performing a variety of system functions, including managing, loading and updating donor data. The appendix at the end of the manual lists several important relationships, such as those between reaction types and reaction categories and between reaction categories and signs and symptoms.

Electronic Uploading of Data Demonstrated for Donor Hemovigilance System

At the 2009 AABB Annual Meeting and TXPO, representatives from Healthcare ID demonstrated their software interface that allows data from blood centers to be uploaded to the donor hemovigilance system. The interface will eliminate the need for data to be entered twice by a facility, increasing efficiency and helping to reduce errors. Mediware Information Systems also has developed and tested such an interface. Other software vendors interested in this project should contact AABB’s Center for Data and Special Programs.

U.S. BIOVIGILANCE NETWORK

White Paper Identifies Gaps in Biovigilance Activities

Current biovigilance activities within the United States are pieced together and lack a cohesive national plan, according to a white paper presented at the recent meeting of the U.S. Department of Health and Human Services Advisory Committee on Blood Safety and Availability. The paper — “Biovigilance in the United States: Efforts to Bridge a Critical Gap in Patient Safety and Donor Health” — detailed the actions by governmental agencies and professional organizations and concluded that while they are functional, some are redundant and others face limitations regarding data collection, analysis and reporting. Identifying gaps associated with blood, tissue and organ biovigilance activities, the authors stated that voluntary and mandatory systems are needed, and the public and private sector efforts should be integrated. It also was noted that while “the lack of a national policy and a pluralistic approach to the safety and availability of blood, tissue and organs” complicates projects, joint governance will be necessary to ensure success.

In a statement presented at the Nov. 19-20 ACBSA meeting, AABB applauded the analysis and noted that the U.S. Biovigilance Network does much to address the issues identified in the white paper, particularly in helping to integrate public and private sector efforts. The association emphasized the need for continued support for the network to ensure that it becomes a more robust system. In particular, government financial support is needed for hospital recruitment, staff education, quality control and data analysis.

U.S. Biovigilance Network Spotlighted at AABB Annual Meeting

The 2009 AABB Annual Meeting and TXPO in New Orleans spotlighted biovigilance efforts within the United States, including the U.S. Biovigilance Network, the hemovigilance module of CDC’s National Healthcare Safety Network, and the donor hemovigilance system. One educational session highlighting the first 100 days of the pilot of CDC’s hemovigilance module allowed attendees to hear the perspectives of four institutions, including helpful hints for preparing to join, the importance of using standardized definitions and early learning experiences. Testing sites for the donor hemovigilance system also presented their perspectives. One educational session focused on global efforts to improve biovigilance — through the addition of cell, tissue, and organ safety — and there were presentations on how the U.S. Biovigilance Network has evolved, including information on the development of the public-private partnership on which the network is based.

Attendees also were able to visit the U.S. Biovigilance Network Pavilion within the TXPO to see demonstrations of the recipient and donor systems. For a fee, handouts and online synchronized sessions from the AABB Annual Meeting are available at the AABB Live Learning Center.

Biovigilance Pioneers Receive President’s Award

Three biovigilance pioneers received the President’s Award at the opening session of the AABB Annual Meeting, honoring their efforts in envisioning and championing biovigilance activities within the United States. The recipients — D. Michael Strong, PhD, MT(ASCP), chair of the AABB Interorganizational Task Force on Biovigilance; Jerry A. Holmberg, PhD, senior advisor for blood policy in the Office of Public Health and Science at the U.S. Department of Health and Human Services; and Matthew J. Kuehnert, MD, FACP, director of the Office of Blood, Organ and other Tissue Safety at CDC — have been key to the development of the recipient and donor hemovigilance systems. At the meeting, Jay E. Menitove, MD, then-president of AABB, said: “These gentlemen have put us on track to raise the bar yet again on patient safety and donor health.” The President’s Award is given to recognize extraordinary public service and contributions by an individual or an organization that furthers AABB's goals and mission.

ON THE ROAD

Blood Community Convenes to Discuss U.S. Biovigilance Network

Paul Ness, MD, director of transfusion medicine at Johns Hopkins Hospital, led a recent meeting of representatives of the Baltimore transfusion medicine and blood banking communities to offer hospitals and blood centers in the area the opportunity to learn about the U.S. Biovigilance Network and hear about his facility’s experiences with the pilot of the hemovigilance module of CDC’s National Healthcare Safety Network. At the Sept. 22 meeting, Ness highlighted the potential of the module to identify trends that may be difficult to detect in a single facility. In addition, Christi Marshall, MT(ASCP)BB, CQA(ASQ), a laboratory supervisor at Johns Hopkins, noted how the system is helping to improve efficiency. Attendees heard other presentations and had the opportunity to ask questions regarding participation, data entry and software interface requirements. The next meeting, to be held Dec. 10 at the AABB National Office in Bethesda, Md., will be co-hosted by Children’s National Medical Center and the American Red Cross. Facilities interested in sending representatives should contact AABB’s Center for Data and Special Programs.

IN THE NEWS

Wall Street Journal Publishes Update on Biovigilance Pilot

An update on the pilot of the hemovigilance module of CDC’s National Healthcare Safety Network recently was published in the health blog of The Wall Street Journal. The blog posting explained that reporting of many transfusion reactions is not required, and it is thought they may be underreported due to fear of punishment. To overcome this obstacle, the hemovigilance module has been established with the goal of confidentially gathering this information in an effort to implement quality improvements within the transfusion medicine community, according to the posting.

ADVANCE Highlights Development, Benefits of U.S. Biovigilance Network

ADVANCE, a publication for medical laboratory professionals, recently highlighted the development and benefits of the U.S. Biovigilance Network. The article details the two-year collaboration between the federal government and organizations involved in blood collection, transfusion, and tissue and organ transplantation to develop the nationwide program. It also notes that because the data will be collected nationally, it will create a more comprehensive picture of what is happening within the field instead of examining isolated events within a facility. The benefits for individual hospitals and blood centers that implement the system also are highlighted, including replacing paper-based reporting systems and developing more efficient processes focused on preventing waste and saving money.