Evaluation of the National Healthcare Safety Network Hemovigilance Module for transfusion‐related adverse reactions in the United States

Abstract

INTRODUCTION: The National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) collects data on the frequency, severity, and imputability of transfusion-associated adverse events. These events contribute to significant morbidity and mortality among transfusion patients. We report results from the first systematic assessment of eight attributes of the HM. MATERIALS AND METHODS: Standard methods were used to assess the HM. Evaluation data included training materials, system modification history, and facility survey information. A concordance analysis was performed using data from the Baystate Medical Center’s (Boston, MA) electronic transfusion reporting system. RESULTS: In 2016, system representativeness remained low, with 6% (277 of 4690) of acute care facilities across 43 jurisdictions enrolled in the HM. In 2016, 48% (2147 of 4453) and 89% (3969 of 4,453) of adverse reactions were reported within 30 and 90 days of the reaction date, respectively, compared to 21% (109 of 511) and 56% (284 of 511) in 2010, demonstrating improved reporting timeliness. Data quality from most reactions was adequate, with 10% (45 of 442) misclassified transfusion-associated circulatory overload reactions, and no incomplete transfusion-transmitted infection data reported from 2010 to 2013. When compared to the Baystate system to assess concordance, 43% (24 of 56) of NHSN-reported febrile reactions were captured in both systems (unweighted kappa value, 0.47; confidence interval, 0.33–0.61). CONCLUSION: Since the 2010 HM pilot, improvements have led to enhanced simplicity, timeliness, and strengthened data quality. The HM serves an important and unique role despite incomplete adoption nationwide. Facility efforts to track and prevent transfusion-associated adverse events through systems like the NHSN HM are a key step toward improving transfusion safety in the United States.

Bacterial contamination and septic transfusion reaction rates associated with platelet components before and after introduction of primary culture: experience at a US Academic Medical Center 1991 through 2017

“…Furthermore, we found no significant difference in at‐issue contamination rates between APs collected at Vitalant with Amicus versus those collected at ARC with primarily Trima (398 vs. 284/million; p = 0.32). The overall STR rate in the Eder study (15/million donations or 31/million transfusions) is also lower than the STRs of 24/million AP transfusions (26/1,069,854) during 2010 to 2016 reported from a national US passive surveillance hemovigilance study …”

“…Additional insight on the problem of STRs from bacterial contamination of AP has been provided by reports from the US National Healthcare Safety Network Hemovigilance Module (NHSNHM) for transfusion‐related adverse reactions . NHSNHM is a voluntary, passive surveillance network that collected data from 82 to 277 participating hospitals per year from 2010 to 2016.…”

Safety incident reports associated with blood transfusions

“…Furthermore, a 2013 NHSN‐HV protocol change made it optional to report incidents that do not cause adverse patient reactions. This resulted in a reduction in incident reporting among AABB CPS hospitals; thus, the system may fail to capture near‐miss, precursor, and “no harm” events related to transfusion . In addition, the lack of consistent incident and denominator reporting to AABB CPS by participating hospitals can indicate either an actual absence of incidents for those time periods or deficient reporting to the NHSN‐HV.…”

Point-of-Care Diagnostics in Coagulation Management

“…Furthermore, empiric administration of fresh frozen plasma (FFP) induces dilution coagulopathy and hypofibrinogenemia [ 51 ]. Transfusion itself is associated with increased mortality [ 52 ] and a high risk of adverse events such as lung damage, volume overload and heart failure, kidney damage, transmission of infections and immunological activation [ 53 , 54 ]. Besides trauma, pathological changes can be caused through intra- and postoperative bleeding.…”