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:

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. These reports provide data on transfusion activity in Massachusetts, as well as information on transfusion-associated adverse events. This report was first developed to share activity from 2017.

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
  • Alfred DeMaria, Jr., MD
    Massachusetts Department of Public Health
  • Deborah Gordon, MD
    Milford Regional Medical Center
  • Michele Herman, BS
    Beth Israel Deaconess Medical Center
  • Ashley Iannone, MPH
    Massachusetts Department of Public Health
  • Kimberly Knox, RN, MHA
    (Formerly) Milford Regional Medical Center
  • Eileen McHale, RN, BSN
    Massachusetts Department of Public Health
  • Lynne O’Hearn, BS
    Baystate Medical Center
  • Jorge Rios, MD
    American Red Cross Blood Services East Division
  • Bentley Rodrigue, MD
    Beth Israel Deaconess Medical Center
  • Jordan Schultz, MPH
    Massachusetts Department of Public Health
  • Amanda Slider, MPH
    Massachusetts Department of Public Health
  • Reggie Thomasson, MD
    Boston Medical Center
  • Lynne Uhl, MD
    Beth Israel Deaconess Medical Center
  • Jason Viau MT(ASCP)
    Massachusetts Association of Blood Banks
  • Pamela Waksmonski, MS
    Massachusetts Department of Public Health

Former members

  • Elzbieta Griffiths, MD
  • Karen Quillen, MD
  • Patricia Pisciotto, MD

Recent References to Massachusetts Hemovigilance Data

  • Kracalik, I, Mowla, S, Katz, L, Cumming, M, Sapiano, MRP, Basavaraju, SV. Impact of the early coronavirus disease 2019 pandemic on blood utilization in the United States: A time-series analysis of data reported to the National Healthcare Safety Network Hemovigilance Module. Transfusion. 2021; 1– 8.
  • Edens C, Haass KA, Cumming M, Osinski A, O’Hearn L, Passanisi K, Eaton L, Visintainer, P, Savinkina A, Kuehnert MJ, Basavaraju SV, Andrzejewski C. Evaluation of the National Healthcare Safety Network Hemovigilance Module for transfusion-related adverse reactions in the United States. Transfusion. 2018;59(2):524-533.
  • Osinski A, Cumming M. Hemovigilance in Massachusetts: A Three-Year Data Summary. In: A Supplement to TRANSFUSION Abstract Presentations from the AABB Annual Meeting, Boston, MA, October 13-16, 2018. Abstract TS39.
  • Cumming M, Brandeburg C, DeJesus A, Herman M, O’Hearn L, Uhl L, Andrzejewski C, and Quillen K. Acute Hemolytic Transfusion Reactions in Massachusetts, 2015-2017. In: A Supplement to TRANSFUSION Abstract Presentations from the AABB Annual Meeting, Boston, MA, October 13-16, 2018. Abstract TS9-MN3-23.
  • Cumming M, Brandeburg C, DeJesus A, Herman M, O’Hearn L, Uhl L, Quillen K, and Andrzejewski C. Transfusion-Associated Circulatory Overload in Massachusetts, 2015-2017. In: A Supplement to TRANSFUSION Abstract Presentations from the AABB Annual Meeting, Boston, MA, October 13-16, 2018. Abstract TS13-MN3-23.
  • Cumming M , Osinski A , O'Hearn L., Waksmonski P , Herman M , Gordon D , Griffiths E , Knox K , McHale E , Quillen K , Rios J , Pisciotto P , Uhl L, DeMaria A and Andrzejewski C. (2017), Hemovigilance in Massachusetts and the adoption of statewide hospital blood bank reporting using the National Healthcare Safety Network. Transfusion, 57: 478-483.

Contact   for Reporting Requirements for Blood Banks and Hemovigilance in Massachusetts

Address

67 Forest Street, Marlborough, MA 01752

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