On November 8, 2013, MDPH informed all Massachusetts blood banks and transfusion services subject to 105 CMR 135.000 of a revised procedure for reporting blood bank activity .
Beginning June 1, 2014, all licensed blood banks and transfusion services in Massachusetts will be required to report transfusion related adverse events using the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) Hemovigilance Module. Prior to that date, blood banks and transfusion services may use NHSN in lieu of reporting on the monthly activity form.
Reporting transfusion related adverse events to NHSN DOES NOT replace reporting patient death or serious injury associated with unsafe administration of blood products as a Serious Reportable Event, 105 CMR 130.332(A). Unsafe administration includes, but is not limited to, hemolytic reactions and administering: a) blood or blood products to the wrong patient; b) the wrong type; c) blood or blood products that have been improperly stored or handled. All such events should be reported to the Clinical Laboratory Program within one business day at 617-753-8439 or 617-753-7014.
Use of the Hemovigilance Module DOES NOT replace the FDA's mandatory requirements for reporting blood transfusion baths or blood product deviation reporting.
To meet this new requirement, facilities must complete required NHSN training, complete all enrollment steps, and report data according to NHSN protocols. Staff training on NHSN methodology, definitions and data entry is provided free via CDC-archived webcasts and slide sets that are available in real-time from any computer.
MDPH is providing assistance to blood banks and transfusion services making the transition from the paper-based method of reporting to the NHSN Hemovigilance Module.
For more information on the new reporting requirement, please contact Eileen McHale at Eileen.email@example.com or 617-753-7324.