What is biovigilance?
Biovigilance is the detection, gathering and analysis of information regarding the untoward and unexpected events associated with blood collection and transfusion and the transplantation of cells, tissues and organs. This systematic surveillance is intended to provide early warnings of safety issues, promote the exchange of valid information, identify applications for practice improvement, and promote educational activities that lead to safer and more efficacious transfusion and transplantation.
What is hemovigilance?
Hemovigilance falls under the umbrella of biovigilance. It is the surveillance of adverse events associated with blood collection and transfusion. The goal of hemovigilance is to improve transfusion safety and blood donor health.
What is the U.S. Biovigilance Network?
The U.S. Biovigilance Network is a national collaboration between government and nongovernment organizations to develop and enhance surveillance systems designed to track adverse reactions and incidents associated with blood collection and transfusion as well as the transplantation of cells, tissues and organs. With a collaborative network in place, results can be analyzed to identify needed improvements and to form the basis for best practice recommendations intended to reduce adverse reactions and errors identified through biovigilance data collection.
Why is the U.S. Biovigilance Network needed?
Experience from other countries suggests that such surveillance systems can help reduce patient morbidity and mortality.
Who is developing the network?
The network is a unique collaborative of public and private interests with shared responsibilities for program development, operation, management and funding. The AABB Interorganizational Task Force on Biovigilance comprises key stakeholders in the transfusion and cellular therapies community, including blood centers, hospitals and experts on data collection. The task force also includes experts from the international community with hemovigilance system experience. The U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, has led the collaboration for the federal government.
What is the timeline for the development of biovigilance?
The collaboration is in two phases. In phase I, hemovigilance was the focus. Fully functional blood recipient and donor systems are open for participation at this time. Phase II will address surveillance of biologics other than blood (i.e., cells, tissues and organs).
With expert input from AABB, CDC developed a system to track adverse events and incidents occurring in blood transfusion. This system is the Hemovigilance 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 took place in 2009, with nine facilities across the U.S. participating. Enrollment is now open for all hospitals.
Similarly, AABB and HHS have collaborated to develop a system to track adverse reactions associated with the donation process at blood collection sites. This system allows both manual data entry and an electronic data submission interface, to avoid unnecessary duplication of data entry.
The CDC and United Network for Organ Sharing, or UNOS, have collaborated to better recognize adverse events associated with tissue and organ transplantation. The Transplantation Transmission Sentinel Network, or TTSN, was developed and piloted through a cooperative agreement, and focuses on improving recognition and communication on such events.
Tracking and learning from events associated with cellular therapies will be a part of phase II. Work has yet to begin in this area, but the task force is interested in collaborating with organizational partners and existing systems.
How is the network financed?
To supplement the federal government's role in developing and hosting the surveillance system, the AABB Interorganizational Task Force on Biovigilance is working to secure additional from the private sector, including blood centers, hospitals, industry vendors/supporters, nonprofit organizations, trade associations, foundations and corporations both inside and outside of the transfusion and transplantation communities. The funding is necessary to recruit and train participants, educate the public and develop staff and volunteer expertise to perform necessary data validation and analyses. It also is important for these systems to become sustainable.
How can I contribute to help enhance the activities of the biovigilance network?
There are three ways to contribute to the network:
- Advocacy: let your leadership know that this is important to you and to patient safety in the U.S.
How are the hemovigilance data protected?
Data entered into the NHSN are confidential and protected by CDC. The CDC will only report aggregate data from the NHSN. Facility specific data can only be shared 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 the AABB Center for Patient Safety — that is, data shared with AABB's Transfusion Safety Group — are protected through the center's status as a "patient safety organization" (see below). This patient safety data collected from hospitals 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 the AABB Center for Patient Safety.
Hospitals can choose to share data with AABB by completing a HIPAA Business Associate Agreement and a PSO Participation and Confidentiality Agreement thereby joining the AABB Center for Patient Safety and using the group function of CDC's NHSN. These data, protected by HIPAA, the Patient Safety Act and by AABB's PSO status, will be used for the development of best practices and to design interventions to improve patient safety.
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.
The AABB Center for Patient Safety, listed as a PSO in December 2008, is dedicated to confidentially analyzing data on adverse reactions and incidents associated with transfusions. The goal of the analyses is to identify and communicate best practices and to design interventions to improve patient safety. This is one of the main objectives of the U.S. Biovigilance Network. To join the Center for Patient Safety, you will need to sign a Business Associate Agreement and Participation and Confidentiality Agreement. Please contact email@example.com for more information.
How can I work with my legal department to get the contracts signed?
The AABB Center for Patient Safety can work with legal departments on a case-by-case basis to resolve any concerns about the contracts. One of the contracts that participating organizations need to sign is a business associate agreement. The PDSC has taken care to ensure that the BAA meets the requirements of HIPAA and HITECH without imposing any unnecessary requirements on either party.
What are groups in NHSN?
Groups are entities that want to share and analyze data across several facilities. They are voluntary to join and easy to create. A group may be composed of a hospital system, a patient safety organization, a state health department and/or quality improvement organization. The group structure does not allow facilities to see which other facilities are in the group nor does it allow a facility to see another's data in that group.
We are an AABB-accredited institutional member — will any of the data be shared with the accreditation arm of AABB?
The AABB Center for Patient Safety and the data it holds are separated from AABB's accreditation function by a robust firewall. Data are never shared between these functions.
How are the data entered into the 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. CDC has been developing the data architecture for software developers to build hemovigilance capacity into their system to facilitate data transfers between local systems and the NHSN. It is estimated that functional interfaces will be available by spring of 2012.
How are the data entered into the Donor Hemovigilance System?
The Donor Hemovigilance 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.
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. Facilities also cannot see the data from other sites except in aggregate form. Participating institutions are able to view and analyze their own data and independently compare their data with national aggregate rates through the NHSN.
Within the Donor Hemovigilance System, donor centers own their data. Facilities cannot see data from other sites except in aggregate form.
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 NHSN Web page.
Hospitals and blood centers are asked to identify adverse reactions and incidents and enter data describing those events into the appropriate system. Staff must be trained and will receive ongoing support to ensure that adverse reactions and incidents are appropriately recognized and data are entered and captured effectively and confidentially.
What training is required?
There are training slide sets available on the NHSN biovigilance component Web page that must be read by the facility administrator. The training is a self-study training that should be completed at the user's convenience prior to using the module. When you enroll in the system, you will be asked to provide your training date.
Do I still have to report to the FDA if I use the Hemovigilance Module?
Yes you do. If some of these reactions or deaths are reportable to FDA, you also must report them to CDC. There is no interoperability between FDA's and CDC's systems.
What is in it for my hospital/blood center?
There are many benefits to participation beyond the satisfaction of contributing to a national system in which adverse events are tracked and compared using standardized definitions. Reducing adverse reactions and errors will help reduce health care costs associated with these adverse events. The recipient and donor systems are tools that facilities can use for continuous quality improvement by benchmarking their own performance against the national aggregate and other facilities of similar size and medical practice. The systems provide numerous reports and quality tools that can be used for local tracking and analysis.
How much does it cost to join either system?
There are no fees for hospitals or blood centers to participate in the network, all facilities should adopt the standardized definitions as soon as possible so that comparisons to the aggregate data are meaningful and best practices can be implemented locally.
Do these systems need to be validated by each facility?
Validation should be completed as required by your local procedures.
Do we need to change our informed consent or get institutional review board, or IRB, approval locally to collect this information on patients and donors?
No, this is public health surveillance (not research); you do not need IRB approval to collect and report these data.
Whom can I speak with to learn more about the U.S. Biovigilance Network?
Questions and expressions of interest to participate in the NHSN should be directed to the Centers for Disease Control and Prevention at NHSN@cdc.gov.
For questions about AABB's involvement in the U.S. Biovigilance Network, contact Barbee Whitaker, PhD, director of the AABB Center for Patient Safety, or call +1.301.215.6574.