More about:

Reporting requirements for Blood Banks

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 baths 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.


Tell us what you think