How do we use the National Healthcare Safety Network for Hemovigilance in Massachusetts?

BACKGROUND: Use of the National Healthcare Safety Network (NHSN) has been essential to the success of the Massachusetts Hemovigilance Program and has allowed for the timely identification of signals and trends over a defined population that correlate with national and international hemovigilance (HV) data. Here, we outline how the NHSN system is used for monitoring HV data in Massachusetts and encourage adoption of NHSN for nationwide HV surveillance. STUDY DESIGN AND METHODS: A collaboration that grew over time between local HV stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for compliance with state requirements to replacement with statewide adoption of reporting via NHSN. RESULTS: Over 1.5 million blood products were transfused in Massachusetts between 2017 and 2021, with 3000 adverse reactions among 10 defined types reported. Using NHSN, MDPH has been able to produce numerous reports, publications, and presentations that have made previously non-obtainable HV and blood utilization data available. DISCUSSION: Although limitations to these self-reported data exist, such as lack of external validation, successful statewide implementation of NHSN for hospital blood bank reporting is possible and has benefits beyond those for regulatory oversight. It results in standardized, actionable data at both the hospital and state level, enabling inter-facility comparisons, benchmarking, and opportunities for practice improvement.

A Comparison of Transfusion-Related Adverse Reactions Among Apheresis Platelets, Whole Blood-Derived Platelets, and Platelets Subjected to Pathogen Reduction Technology as Reported to the National Healthcare Safety Network Hemovigilance Module.

Despite advances in transfusion safety, concerns with safety of platelet transfusions remain including platelet-related sepsis and higher reaction rates observed among patients receiving apheresis platelets (APLTs). National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) data were analyzed to quantify the burden and severity of adverse reactions occurring from APLTs and whole blood-derived platelets (WBD-PLTs). Facilities participating in NHSN HM during 2010-2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for APLTs and WBD-PLTs stratified by severity, use of platelet additive solution (PAS), and pathogen reduction technology (PRT). Chi-square tests were used to compare rates. During the study interval, 2,000,589 platelets were transfused: 1,435,154 APLTs; 525,902 WBD-PLTs; and among APLTs, 39,533 PRT-APLTs. APLT adverse reaction rates were higher (478 vs 70/ 100,000, P< .01) and more often serious (34 vs 6/100,000; P< .01) compared with WBD-PLTs. Adverse reactions were higher among PRT-APLTs (572/100,000) and were less often serious (18/100,000) compared with non-PRT-APLTs (35/100,000) although this association was not statistically significant. Among components implicated in adverse reactions, 92% of APLTs were suspended in plasma. Compared with PRT-APLTs stored in PAS, rates were higher among units stored in plasma (760 vs 525/100,000). Most serious reactions (75%) were allergic. No transfusion-transmitted infections were reported among PRT-APLTs. APLTs were associated with a 6-fold and 2-fold higher serious adverse reaction risks compared with WBD-PLTs and PRT-APLTs, respectively. These findings demonstrate the importance of monitoring transfusion-related adverse reactions to track the safety of platelet transfusions and quantify the impact of mitigation strategies through national hemovigilance systems.

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

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 (Springfield, 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.

Enhancing hemotherapy safety through pertinent diagnostic testing and electronic "provisional diagnosis" reporting: expanding roles for blood bank technologists in biovigilance and patient safety.

BACKGROUND: Suspected transfusion reaction (STR) investigations are foundational for biovigilance. Diagnostic evaluations performed by blood banks may prolong turnaround times (TATs) for final STR results reporting. We identified a quality improvement opportunity using diagnostic testing reflex algorithms and our hospital's patient electronic health record to enhance TATs regarding one aspect of STR results reporting. STUDY DESIGN AND METHODS: We conducted a descriptive quality improvement study of reported STR cases investigated by our hospital's blood bank from March 1, 2014, to December 31, 2016, using data obtained from consult reports/quality improvement databases examining the number and types of diagnostic algorithm reflex activations performed and the TATs for an electronic provisional diagnosis reporting (PDXR) related to them. RESULTS: A total of 461 STR events occurred during the study interval, of which 150 involved no reflex testing. In the remainder of cases (n = 311), a total of 448 reflex activations occurred. In those cases in which PDXR occurred (n = 446), the median PDXR TAT during the first month of implementation was 325 minutes, which progressively decreased to 70 minutes or less approximately 1 year after implementation. By the last quarter of 2015, median TATs were 60 minutes or less in length, where they remained for the duration of the study. CONCLUSION: Technologists using targeted diagnostic reflex arcs to expedite laboratory testing along with STR electronic PDXR improve communication and timely results/information dissemination, potentially aiding bedside hemotherapy-related clinical decision making.

Hemovigilance in Massachusetts and the adoption of statewide hospital blood bank reporting using the National Healthcare Safety Network.

A collaboration that grew over time between local hemovigilance stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for regulatory compliance purposes to statewide adoption of electronic reporting via the National Healthcare Safety Network (NHSN). The NHSN is a web-based surveillance system that offers the capacity to capture transfusion-related adverse events, incidents, and monthly transfusion statistics from participating facilities. Massachusetts' hospital blood banks share the data they enter into NHSN with the MDPH to satisfy reporting requirements. Users of the NHSN Hemovigilance Module adhere to specified data entry guidelines, resulting in data that are comparable and standardized. Keys to successful statewide adoption of this reporting method include the fostering of strong partnerships with local hemovigilance champions and experts, engagement of regulatory and epidemiology divisions at the state health department, the leveraging of existing relationships with hospital NHSN administrators, and the existence of a regulatory deadline for implementation. Although limitations exist, successful implementation of statewide use of the NHSN Hemovigilance Module for hospital blood bank reporting is possible. The result is standardized, actionable data at both the hospital and state level that can facilitate interfacility comparisons, benchmarking, and opportunities for practice improvement.

Hemotherapy bedside biovigilance involving vital sign values and characteristics of patients with suspected transfusion reactions associated with fluid challenges: can some cases of transfusion-associated circulatory overload have proinflammatory aspects?

BACKGROUND: Monitoring of patients' vital sign values (VSVs) during hemotherapy may have an important role in the recognition and mitigation of transfusion-associated circulatory overload (TACO). Knowledge regarding VSVs and other patient characteristics in bedside-reported TACO or fluid challenge-suspected transfusion reactions (TACO/FC-STRs) is limited. STUDY DESIGN AND METHODS: We performed a retrospective observational cohort study of cases of uncomplicated red blood cell (RBC) transfusions (UCTs) and reported suspected transfusion reaction (STR) cases investigated by our hospital's transfusion medicine service (TMS) from January 1, 2005, to February 29, 2008, using data obtained from TMS consult reports and quality improvement databases examining VSVs and patient characteristics in TACO/FC-STRs. RESULTS: The frequency of TACO/FC-STRs was 0.19% per all RBC units transfused (1:530 units transfused). Both clinically and statistically (p≤0.05) significant changes were encountered in all VSVs in patients experiencing TACO/FC-STRs either at the 15-minute time interval or at the end-of-transfusion time points. Measured and derived VSVs related to the patients' blood pressure in the peritransfusion period were consistently increased. Approximately two-thirds of TACO/FC-STR patients also exhibited inflammatory related signs and symptoms at STR bedside presentation. Differences (all p≤0.050) between UCT and TACO/FC-STR cohorts were seen for patient mean weights (80 kg vs. 72 kg), mean minutes to transfusion completion (121 min vs. 83 min), and mean storage age of suspected sentinel RBC unit (22.5 days vs. 25.2 days). CONCLUSION: Trend monitoring of peritransfusion VSVs, especially blood pressures, may aid in the bedside recognition of TACO/FC-STRs. A subset of these patients may also present with febrile and/or inflammatory signs and symptoms.