For Blood / Biologics

U.S. Biovigilance Network: Hemovigilance System
by Barbee Whitaker, Ph.D. AABB, Director, Data and Special Programs

AABB, formerly the American Association of Blood Banks, and the Department of Health and Human Services have partnered to develop the U.S. Biovigilance Network. This network will, for the first time on a nationwide basis, collect and analyze data to identify trends and recommend best practices to reduce adverse reactions and incidents associated with blood transfusion and related biological therapies. Ultimately, the analyses of this data will enhance patient safety, make better use of blood and biological therapies, and reduce healthcare costs. The first system to be rolled out from the network is the Hemovigilance System. Hemovigilance is the detection, gathering and analysis of information regarding the untoward and unexpected events associated with blood transfusion and collection.

The analyses of this data will enhance patient safety, make better use of blood and biological therapies, and reduce healthcare costs.

The pilot kick off for the system is expected in January 2009 with nine hospitals of varying sizes and specialties. These hospitals will enter all of their adverse transfusion reactions into a web-based interface using a system of pull-down menus and check boxes to indicate specific information about the patient, the blood components involved in the transfusion reaction, the details about the reaction, its severity and outcome. Once a hospital joins the system and enters data about adverse reactions into the national system, hospitals can compare their data with other hospitals of comparable size and specialty from anywhere in the country.

Another important contribution to patient safety is the ability to learn from our mistakes. The Hemovigilance System has a section for entering data about incidents. Incidents are called different things in different places: occurrences, variances, process deviations, near misses. Often these never reach the patient and never cause harm; however, much can be learned from studying when and why they occur and why they are prevented from reaching the patient. The hemovigilance system has several features for tracking incidents in detail and in summary, which will allow hospitals to learn from their patterns and to compare their performance with that of other similar sized or structured institutions.

An important new element of a national hemovigilance system is the widespread promulgation of common definitions for adverse transfusion reactions and incidents associated with transfusions. AABB has brought together a panel of experts to develop and harmonize these definitions into what will be included in the hemovigilance system. The definitions are consistent with International Society of Blood Transfusion (ISBT) definitions so that results from the system will be comparable internationally as well as between hospitals nationally.

Many of the reactions and incidents that the U.S. Hemovigilance System will track are rare events. Any given hospital may only see a small number of reactions in a year and with such rare occurrences, it is difficult to learn or to draw meaningful conclusions. Patients having the reactions may have as many differences as similarities. However, with a national system, the rare occurrences will be combined; the commonalities in cases will become evident and gain significance. Causality and relationships between contributing factors may appear, which would not have been apparent with smaller datasets. AABB and its membership are very excited about the possibilities of enhancing patient care through the lessons that can be learned from a national database. The U.S. Hemovigilance System needs only a base of approximately 20% of the United States transfusing hospitals participating, in order to become one of the largest systems in the world.

The Hemovigilance System offers many opportunities to generate reports and analyses that a hospital may not have available locally. These can be used for local transfusion and quality committees while standard reports track incidents and adverse reactions across defined periods and provide a variety of rates and comparisons. The system also will provide statistical analyses and custom reports for more interested users. One of the features which is unique to the system development platform is its ability to provide benchmarking comparisons. When a hospital joins the U.S. Hemovigilance System, it provides some basic information about its size and specialties. These can be used to compare a large university hospital against another large university hospital or a small cancer center with another small cancer center, no matter where they are located in the United States.

Participation in the system is voluntary and anonymous. If a hospital does not have a quality system for tracking adverse reactions and incidents associated with transfusion internally (and only about 35% of the U.S. hospitals report that they have such systems), the national system can be used for that purpose. There are fields that can be customized for the individual hospital's use to make it more personalized. The data continues to be owned by the hospital, but the aggregate data will be owned by the Centers for Disease Control (CDC). The aggregate data can be used by the participating hospitals, too. A hospital can look at its performance from month to month, compare itself to other similar hospitals, and also compare itself to the national averages for a variety of parameters.

As the data accumulates in the system, hospitals will be using their data and the system for their own needs and reports. The national aggregate data will be reviewed regularly for trends in adverse reactions and incidents. When there are sufficient data in the system, the data will be mined by transfusion medicine experts looking to develop interventions that will improve the practice of transfusion medicine. Other elements of the system, the incident component, for example, will be reviewed and mined as well, by those looking for process improvement steps that will enhance patient safety and reduce costs.

The cost to the hospital to participate in the U.S. Hemovigilance system is small. There are no fees associated with participation in the system. The hospital already collects and monitors much of the data to be entered into the system. The hospital must have a web-accessible computer and someone to enter the data into the U.S. Hemovigilance System. As the system is for surveillance, the data can be entered into the system after the investigation of the reaction or incident is complete, and therefore at the convenience of hospital staff. AABB is meeting with software developers to discuss interface possibilities for electronic submission of data where it exists in resident systems.

If you are interested in learning more about the U.S. Biovigilance Network or the U.S. Hemovigilance System, visit www.aabb.org/biovigilance.

Dr. Barbee Whitaker is Director of Data and Special Programs with AABB, formerly the American Association of Blood Banks. She is responsible for AABB's developing Biovigilance activities in coordination with the U.S. Department of Health and Human Services and the Centers for Disease Control and she supports the Interorganizational Task Force on Biovigilance, a collaborative effort among AABB, the Federal government, and other key stakeholders in the transfusion medicine community. Dr. Whitaker is the principal investigator responsible for the National Blood Collection and Utilization Surveys done in collaboration with the Department of Health and Human Services. Prior to joining AABB she was with the Plasma Protein Therapeutics Association and with the American Red Cross. Dr. Whitaker received her undergraduate degree in biology from Princeton University and her Ph.D. from Rutgers University in behavioral endocrinology.

Additional Information
"A National Biovigilance Network," http://www.dhhs.gov/bloodsafety/presentations/WhitakerAABBACBSA0806.pdf


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CAPA Quiz
Is it a Correction, a Corrective Action, or a Preventative Action? Read each CAPA scenario carefully. Decide whether the scenario is a Correction (C), Corrective Action (CA) or a Preventive Action (PA). Select one answer only! If the answer you selected is correct you will continue to the next scenario. If it is not correct you can try again!
A batch of IV solution was found to be mislabeled in the warehouse. It is very unlikely that even if used anyone would be harmed. You decide to relabel all bottles in the warehouse.




You shipped an order to the wrong customer. This created a major problem for the customer who needed the product and didn’t get it on time. You added a review step in the process to prevent this from happening again.




Your organization created a process for restarting your production line to ensure you don’t create defects after any shut-down.




The O-rings in the #1 clamp press machine started to come out oversized. A cause analysis determined that the molds wear down after 15,000 presses. The SOP was changed and now requires the molds to be replaced at 15k parts. Based on this knowledge you decide you will replace the molds on the #2 press at 15,000 pieces even though the product is in specs.




About 10% of the tamper proof seals were found to be broken at the end of the production line. You conducted a 100% inspection of your warehouse and sorted and quarantined the bad product.




A batch of IV solution was found to be mislabeled in the warehouse. It is very unlikely that even if used anyone would be harmed. You decide to relabel all bottles in the warehouse.




You shipped an order to the wrong customer. This created a major problem for the customer who needed the product and didn’t get it on time. You added a review step in the process to prevent this from happening again.




Your organization created a process for restarting your production line to ensure you don’t create defects after any shut-down.




The O-rings in the #1 clamp press machine started to come out oversized. A cause analysis determined that the molds wear down after 15,000 presses. The SOP was changed and now requires the molds to be replaced at 15k parts. Based on this knowledge you decide you will replace the molds on the #2 press at 15,000 pieces even though the product is in specs.




A batch of IV solution was found to be mislabeled in the warehouse. It is very unlikely that even if used anyone would be harmed. You decide to relabel all bottles in the warehouse.




You shipped an order to the wrong customer. This created a major problem for the customer who needed the product and didn’t get it on time. You added a review step in the process to prevent this from happening again.




Your organization created a process for restarting your production line to ensure you don’t create defects after any shut-down.




The O-rings in the #1 clamp press machine started to come out oversized. A cause analysis determined that the molds wear down after 15,000 presses. The SOP was changed and now requires the molds to be replaced at 15k parts. Based on this knowledge you decide you will replace the molds on the #2 press at 15,000 pieces even though the product is in specs.




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