A Roadmap for Adoption of Transfusion-Related Adverse Event Reporting Using the National Healthcare Safety Network

BACKGROUND:   The National Healthcare Safety Network (NHSN) is used by US healthcare facilities to report patient safety outcomes. Since 2010, the NHSN Hemovigilance Module (HM) has been available for voluntary reporting of transfusion-related adverse events. Reporting in the HM includes: transfusion-associated adverse reactions; errors associated with reactions; components transfused or discarded; and cross match samples. On June 1, 2014, Massachusetts Department of Public Health (MDPH) became the first state health department to require all blood banks utilize HM to report monthly adverse event data. We present a roadmap for how successful statewide implementation in Massachusetts (MA) can inform efforts elsewhere. Also, early hemovigilance data from MA blood banks can further demonstrate the utility and value of the HM.

METHODS:   Implementation in Massachusetts of reporting through NHSN was multi-phased: assessment/engagement; decision/pre-implementation; enrollment; and maintenance/analysis. The Assessment/Engagement Phase included engaging and partnering with regulatory counterparts; identifying all blood banks and introducing the initiative to build a collaborative relationship; strengthening relationships with local hemovigilance champions/stakeholders; obtaining guidance through a technical advisory group (TAG); and surveying blood banks to assess knowledge and attitudes regarding hemovigilance and NHSN.  The Decision/Pre-Implementation Phase involved: obtaining support from key stakeholders; mandating statewide reporting through NHSN with support from regulatory counterparts; announcing the mandate in advance to allow for training, communication, and anticipation of challenges. The Enrollment Phase involved supporting and communicating with users to assist with compliance. The Maintenance/Analysis Phase involved: ongoing user support and efforts toward improving data quality; communicating with users and the TAG for sharing and reporting statewide aggregate data; and developing benchmarks to inform transfusion safety initiatives.

RESULTS:   From preliminary analysis of Massachusetts’ HM data during July 2014 – October 2014, 56 blood banks reported that 117,988 components were transfused (67.3% RBCs, 11.4% platelets, 14.2% plasma, and 7.2% cryoprecipitates). In patients transfused, 135 transfusion-related adverse reactions occurred, of which 20 were either severe or life-threatening.  Massachusetts-specific data will inform quarterly reports to the TAG regarding utilization and adverse reaction incidence, with the goal of allowing for comparison across facilities and creating benchmarking metrics.

CONCLUSIONS:   From our experience, key lessons learned are to engage local hemovigilance champions, establish and maintain relationships with blood bank supervisors and medical directors, partner early with regulatory counterparts to consider deadlines for implementation, and utilize CDC support. Adoption of mandatory reporting will result in valuable data which can be used to improve patient safety and reduce adverse transfusion-related outcomes.