Phase I:

         AABB and CDC are working in collaboration to develop a system to track adverse events and incidents occurring in blood transfusion. This system is a module of the National Healthcare Safety Network, or NHSN, a patient safety surveillance system operated by the Division of Healthcare Quality Promotion at the CDC. The pilot for this module begins in spring 2009 in nine facilities across the United States. Open enrollment for all facilities is planned for later in the year.

         AABB and HHS are also collaborating to develop a system to track adverse reactions associated with the donation process at blood collection sites. This system will meet the needs of the collection facilities through electronic data submissions to avoid unnecessary duplication of data entry.

Phase II:

         The CDC and United Network for Organ Sharing, or UNOS, have collaborated on better recognition of adverse events associated with tissue and organ transplantation. The Transplantation Transmission Sentinel Network, or TTSN, has been developed and piloted through cooperative agreement, and focuses on improving recognition and communication on such events.  It is hoped that TTSN will be developed for implementation nationally. As the network evolves, representatives will identify how such collaboration will work to include organ and tissue safety.

         Cellular therapies will be the fourth system and, as with organs and tissues, will be part of Phase II to be implemented after the transfusion recipient and blood donor systems are in place. Work has not yet begun on planning for incorporation of cellular therapies, but the task force is interested in collaborating with organizational partners. 

7)     When will facilities begin participating in CDC’s hemovigilance module that is a product of this collaborative biovigilance network? 
The pilot phase for the transfusion recipient system, which is being developed as a hemovigilance module within CDC’s NHSN, began in spring 2009 with nine hospitals participating. This phase will allow for fine-tuning of definitions and protocol. The blood donor component will open in fall 2009.

8)     How do I contribute to help enhance the activities of the biovigilance network? 
There are three ways to contribute to the network: through resource contribution, volunteering to contribute data to the network, and becoming an advocate for the network.

9)      How is the network financed? 

To supplement the federal government’s role in developing and hosting the surveillance system, the Interorganizational Task Force on Biovigilance is working to secure additional start-up funding for the U.S. Biovigilance Network from the private sector, including blood centers, hospitals, industry vendors/supporters, nonprofit organizations, trade associations, foundations and corporations both within and outside of the transfusion and transplantation medicine communities. The funding is necessary to complete Phase I development of the project, including recruiting and training participants, educating the public, and developing staff and volunteer expertise to perform necessary data validation and analyses, as well as to provide for its sustained operation.

About $3 million is needed from the private sector to ensure success of the project through contribution of expertise, recruitment, related education and training programs, and community and public outreach. As of March 2009, more than $1.4 million in commitments from the private sector had been received. Additional government funding is being sought to cover ongoing operations following completion of the development efforts.

10)   How  are the hemovigilance data protected? 
Data entered into the National Healthcare Safety Network, or NHSN, are confidential and protected by CDC. Only aggregate data will be released outside of the NHSN. Nonaggregate data can be shared only with the permission of the participating institution that provided the data.

The CDC provides the following assurance of confidentiality:  The information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence, will be used only for the purposes stated, and will not otherwise be disclosed or released without the consent of the individual, or the institution in accordance with Sections 304, 306 and 308(d) of the Public Health Service Act (42 USC 242b, 242k, and 242m(d)). Details are available on CDC's Web site. 

All data held in AABB’s Patient and Donor Safety Center, i.e., data shared through the NHSN group function and data submitted to the Donor Biovigilance System, are protected through center’s status as a “patient safety organization” (see below). This patient safety data collected from hospitals and blood centers will be held privileged and confidential to the fullest extent of the Patient Safety and Quality Improvement Act of 2005, and all identifiable information will be accessible only by the hospital or blood collection facility that contributes these data or by AABB’s Patient and Donor Safety Center.

Hospitals can choose to share data with AABB by joining AABB’s Patient and Donor Safety Center through the group function of CDC’s NHSN. These data, protected by the Patient Safety Act and by AABB’s PSO status, will be used for the development of best practice recommendations and design of interventions to improve patient and donor health.

11)   What is a PSO, and why do we need it? 
Patient safety organizations, or PSOs, are organizations dedicated to improving patient safety and the quality of health care delivery. The Patient Safety and Quality Improvement Act of 2005, commonly referred to as the Patient Safety Act, authorizes the creation of PSOs to improve safety and quality through the collection and analysis of data on adverse events and medical errors. By providing legal privilege and confidentiality protections, PSOs create a secure environment where health care providers can voluntarily collect, aggregate, and analyze patient safety data that enable the identification and reduction of risks and hazards associated with patient care.

AABB’s Patient and Donor Safety Center, listed as a PSO in December 2008, is dedicated to confidentially analyzing data on adverse reactions and incidents associated with transfusions and blood donations. The goal of the analyses is to identify and communicate best practices and to design interventions to improve patient safety and to protect donor health.  This is one of the main objectives of the U.S. Biovigilance Network.

12)   How are the data entered into the Recipient Hemovigilance Module? 
The system is housed within CDC and is a module of the NHSN.  At this time, data entry into the NHSN is a manual, Web-based process. AABB and CDC are beginning the process of discussions with hospital IT vendors to develop electronic interfaces for automated information exchange.

13)   How are the data entered into the Donor Hemovigilance Module? 
The Donor Biovigilance System is designed for both manual data entry and an automatic file-based upload.

The Donor Hemovigilance System Interface Control Document contains information pertinent to the understanding, definition, format, and interchange of data with the Donor Hemovigilance System.

14)   Who owns the data? 
Within the recipient system, the hospital owns the data it contributes, while the CDC owns the aggregate data. Data entered into the NHSN are kept confidential and protected in accordance with the Public Health Service Act and can be disclosed or released only in nonaggregate form with permission from the institution. Participating facilities are able to view and analyze their own data and, where appropriate, independently compare their data with national aggregate rates through the NHSN. Facilities cannot see the data from other sites except in aggregate form.

AABB’s Patient and Donor Safety Center owns the data entered into the donor system in order to ensure all donor data, as well as all analysis and reports generated from these data, are held confidential and legally protected in accordance with the Patient Safety and Quality Improvement Act of 2005. (Each donor center continues to own its own data.)  AABB’s Patient and Donor Safety Center shall retain all rights, title and interest to the data reported into its system as well as all software and reports generated from the data.

15)   How were data elements established? 
Data elements were established through the participation of expert working groups for both the recipient and donor systems. The groups worked for many months to design the systems so that the appropriate variables would be collected to meet the goals of the systems. In addition, the working groups developed standardized definitions that permit comparison of similar cases, consistent with internationally recognized definitions to ensure that all results and recommendations are utilized to their full extent to improve patient safety and to protect donor health.

The NHSN Hemovigilance Module Protocol and Tables of Instructions are available on the CDC Web Site.

Hospitals and blood collection facilities are asked to identify adverse reactions and incidents and enter data describing those events into the appropriate system. Staff will receive training and support to ensure that adverse reactions and incidents are appropriately recognized and data are entered and captured effectively and confidentially.

16)   What’s in it for me and my hospital/donor center? 
There are many benefits to participation beyond the satisfaction of contributing to a national system where adverse events are tracked and compared using standardized definitions. Reducing adverse reactions and errors will help reduce direct patient care costs and overall health care costs associated with these adverse events. The system is a tool that participants can use for continuous quality improvement by benchmarking their own performance against the national aggregate and others of similar size and medical practice. The system provides numerous reports and quality tools that can be used for local tracking and analysis.

All hospitals should adopt the standardized definitions as soon as possible so that comparisons to the aggregate data are meaningful and best practice recommendations can be implemented locally.

Additionally, there are no fees for hospitals or blood banks to participate in the network.

17)   Does this system need to be validated by each center? 
Validation should be completed as required by your local procedures.

18)   Do we need to change our informed consents or get institutional review board approval locally to collect this information on patients and donors at a national level? 
No, this is public health surveillance, not research, so you do not need institutional review board approval to collect and report these data.

19)    Who can I speak with directly in order to find out more about the U.S. Biovigilance Network? 
Questions and expressions of interest should be directed to the National Healthcare Safety Network.

For questions about AABB’s involvement in the hemovigilance component of the U.S. Biovigilance Network, contact Barbee Whitaker, PhD, director of AABB’s Patient and Donor Safety Center, or call +1.301.215.6574.