How is national recipient hemovigilance conducted in the United States?

Abstract

A national recipient hemovigilance system was introduced in the United States in 2010, when voluntary enrollment began as part of the National Healthcare Safety Network (NHSN) Hemovigilance Module. NHSN is a secure, Web-based surveillance system operated by the Centers for Disease Control and Prevention and used by US health care facilities to report a variety of patient safety information. The Hemovigilance Module is used for comprehensive monitoring of transfusion-related adverse events. Participating facilities can utilize analytic tools available within the module to identify opportunities for enhancing transfusion safety, evaluate the effectiveness of interventions, and compare facility specific transfusion-related data to aggregate national estimates. Data may be voluntarily shared by facilities with external partners for patient safety improvement initiatives and to fulfill reporting mandates. We describe the key characteristics of the Hemovigilance Module, highlight the benefits for participating facilities, and discuss the use of reported data for establishing national estimates of transfusion-associated adverse events to identify gaps in transfusion safety and opportunities for interventions. National hemovigilance systems are essential to recognize gaps in transfusion safety and identify opportunities for interventions to improve patient safety and outcomes.

Figure 1. Development timeline of the NHSN Hemovigilance Module

The concept for the Hemovigilance Module was introduced in 2006 with development beginning in 2007 in collaboration with expert groups convened by AABB. In 2009, the module was piloted in 9 facilities, and national enrollment began in January 2010. In 2011, the total number of facilities that enrolled in the module reached 100. The first progress reports were presented in 2012. In 2013, in an effort to increase participation, the protocol was simplified such that near-miss and no-harm incidents were no longer required.

Figure 2. NHSN Hemovigilance Module Data Flow Chart

Participating hospitals report an annual survey, components transfused monthly, adverse transfusion reactions, and incidents associated with reactions to the NHSN Hemovigilance Module. CDC conducts national aggregate data analyses. Facilities may also share their data with groups within NHSN. Groups may include patient safety organizations (PSO), hospital systems, and state and local health departments. These data can be used for benchmarking, allowing hospitals to monitor transfusion processes and outcomes, or fulfilling state and local mandatory reporting. Facilities may use the data for facility-level process improvements.

Figure 3. General case definition criteria for an adverse transfusion reaction to NHSN Hemovigilance Module

The NHSN Hemovigilance Module protocol specifies the case definition for 12 adverse transfusion reactions based on the presence of signs, symptoms, and laboratory and radiographic data. Reactions are reported with a severity designation based on clinical outcomes. Imputability designations which specify the likelihood that reaction was associated with the transfusion event are also reported.