Reporting Requirements for Blood Banks and Hemovigilance in Massachusetts

Information about transfusion-related adverse event and Serious Reportable Event reporting for Blood Banks in Massachusetts

All licensed blood banks and transfusion services in Massachusetts are required to report transfusion-related adverse events using the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) Hemovigilance Module.

Facilities must complete the required NHSN training and all enrollment steps to report through the Hemovigilance Module. All data must be reported according to the NHSN protocols.

Recorded training webcasts for staff on the NHSN methodology, definitions, and data entry are available on the CDC website:

Please note that reporting through the Hemovigilance Module does not replace the FDA's mandatory requirements for reporting blood transfusion deaths or blood product deviation reporting.

Serious Reportable Event (SRE) reporting requirements

The reporting of transfusion-related adverse events to the NHSN does not replace the reporting of Serious Reportable Events (SRE) by blood banks. Licensed blood banks must also continue to report patient death or serious injury that is associated with the unsafe administration of blood products as a Serious Reportable Event. Unsafe administration includes, but is not limited to hemolytic reactions and administering:

  • Blood or blood products to the wrong patient;
  • The wrong blood type; or
  • Blood or blood products that have been improperly stored or handled.

All such events should be reported to the Clinical Laboratory Program within 1 business day.

Hemovigilance Data

Licensed blood banks and transfusion services in Massachusetts are required to participate in the National Healthcare Safety Network (NHSN) Hemovigilance Module.

The Hemovigilance Program Data Summary Report includes data collected through the NHSN Hemovigilance Module from Massachusetts blood banks. This report provides baseline data on transfusion activity in Massachusetts, as well as information on transfusion-associated adverse events.

Hemovigilance Technical Advisory Group

The Massachusetts Hemovigilance Technical Advisory Group (HV TAG) was established in 2013, prior to implementation of statewide hemovigilance reporting through the National Healthcare Safety Network (NHSN). The purpose of the HV TAG is to provide consultation and representation from the Massachusetts transfusion community on issues including but not limited to:

  • the use of the NHSN Hemovigilance Module
  • data reporting and analysis
  • benchmarking
  • data validation

The Department of Public Health is grateful for the support and guidance provided by this dedicated group of transfusion medicine stakeholders.

Current Members

Chester Andrzejewski, Jr., PhD, MD
Baystate Health/ Baystate Medical Center

Christina Brandeburg, MPH
Massachusetts Department of Public Health

Melissa Cumming, MS
Massachusetts Department of Public Health

Alexandra DeJesus, MPH
Massachusetts Department of Public Health

Alfred DeMaria, Jr., MD
Massachusetts Department of Public Health

Elzbieta Griffiths, MD
Mount Auburn Hospital

Michele Herman, BS
Beth Israel Deaconess Medical Center

Kimberly Knox, RN, MHA
Milford Regional Medical Center

Eileen McHale, RN, BSN
Massachusetts Department of Public Health

Lynne O’Hearn, BS
Baystate Medical Center

Anthony Osinski, MPH
Massachusetts Department of Public Health

Jorge Rios, MD
American Red Cross Blood Services East Division

Lynne Uhl, MD
Beth Israel Deaconess Medical Center

Pamela Waksmonski, MS
Massachusetts Department of Public Health

Former Members

Deborah Gordon, MD

Patricia Pisciotto, MD

Karen Quillen, MD

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