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Biovigilance Update - Spring 2010

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SPRING 2010

IN THIS ISSUE

Enrollment Under Way for Hemovigilance Module »

Materials Available to Facilitate Participation in the Hemovigilance Module »

AABB Establishes Transfusion Safety Group in Hemovigilance
Module »

AABB Audioconference to Highlight Common Definitions and Reporting in Hemovigilance Module »

AABB Annual Meeting to Feature U.S. Biovigilance Network Activities »

European Organizations Work to Develop Guidance and Training Documents on Cell and Tissue Safety »

New AABB West Nile Virus and Chagas’ Disease Tracking Maps Add Increased Functionality for Users »

AABB Biovigilance-Accreditation Firewall Discussed at Meeting on U.S. Biovigilance Network »

JAMA Article Highlights Hemovigilance Module »

Scientific American Features AABB Chagas’ Disease Biovigilance Network Tracking Map »

PATIENT SYSTEM

Enrollment Under Way for Hemovigilance Module

Just three months after the launch of the Hemovigilance Module of the Centers for Disease Control and Prevention’s National Healthcare Safety Network, or NHSN, many hospitals are either currently participating or are in various stages of enrollment. The ultimate aim of the module, a surveillance system for tracking adverse events associated with blood transfusions, is to improve patient safety by helping health care personnel identify problematic trends in their individual hospitals as well as in the nationwide transfusion medicine community. Interested facilities must enroll in the NHSN or, if already enrolled, must ask their NHSN facility administrator to add the Hemovigilance Module to their suite of NHSN components. Participation is voluntary and confidential. All data are fully protected and are not legally discoverable.


Materials Available to Facilitate Participation in the Hemovigilance Module

Educational materials, including instructions, are available to facilitate a hospital’s participation in the NHSN Hemovigilance Module. CDC also has made available six forms, which can be used to assist with entering data into the system electronically. One form that should be used right away is the annual facility survey, which must be completed prior to entering event-specific data. All of the forms can be used prior to official enrollment in the module to allow individuals to become familiar with the necessary data collection steps and to have the data readily available for entry upon enrollment.


AABB Establishes Transfusion Safety Group in Hemovigilance Module

AABB has established a group within CDC’s NHSN Hemovigilance Module to perform targeted patient safety analyses for hospitals. An NHSN group is a collection of facilities within the NHSN framework that share their data for a specific purpose. Facilities have the option of joining one or more groups within the system. The purpose of the AABB Transfusion Safety Group is to perform analyses on the group’s hemovigilance data with the intent of developing interventions that will lead to enhanced patient safety. Additionally, through its group, AABB will review data on a confidential basis for individual hospitals and provide in-depth analyses and recommendations for enhancements to patient safety specifically at those facilities. As in the NHSN in general, data shared with the AABB Transfusion Safety Group, a patient safety organization, are fully protected and are not legally discoverable. Those seeking more information about AABB’s group should contact Barbee I. Whitaker, PhD, director of data and special programs at AABB, by phone at 301-215-6574 or by e-mail.


AABB Audioconference to Highlight Common Definitions and Reporting in Hemovigilance Module

AABB will host an audioconference June 9 focusing on blood transfusion-related adverse reactions as defined in the NHSN Biovigilance Component Protocol. The definitions, developed by the AABB Hemovigilance Working Group for NHSN participants, can be used by transfusion service personnel when reporting in the Hemovigilance Module. During the audioconference, adverse reaction criteria will be applied to actual case examples. Some of the reactions that will be discussed include transfusion-associated circulatory overload, transfusion-related acute lung injury, transfusion-associated graft-versus-host disease, hemolytic reactions, allergic reactions and infections. One free registration per site is offered for this program. Facilities can register for this audioconference on the AABB website.


U.S. BIOVIGILANCE NETWORK

AABB Annual Meeting to Feature U.S. Biovigilance Network Activities

The U.S. Biovigilance Network will be a key feature of the AABB Annual Meeting and CTTXPO, being held Oct. 9-12 in Baltimore. Biovigilance activities will focus on a major blood surveillance system developed as a result of the network’s public-private partnerships — CDC’s NHSN Hemovigilance Module. The goal of this system is to improve patient safety in the U.S. by tracking adverse events associated with transfusion.

Several educational and training sessions are planned, including a hemovigilance training day, which will be held Thursday, Oct. 7, two days before the official start of the meeting. Also planned is “Biovigilance 101,” a session that will give an overview of the U.S. Biovigilance Network, including its development. “Implementing Hemovigilance — Experiences of Hospitals Large and Small” will provide information on the experiences, including early successes, of some participants as they implemented the program. All attendees are encouraged to stop by the Biovigilance Pavilion during the meeting to receive additional information, see demos and ask questions they might have. Registration for the Annual Meeting and CTTXPO opened May 13 for AABB members and will open June 1 for general attendees. Registration for the hemovigilance training day is open to general attendees but is limited to the first 125 individuals.


European Organizations Work to Develop Guidance and Training Documents on Cell and Tissue Safety

Several European organizations including the U.K.’s Human Tissue Authority are developing guidance and training documents on cell and tissue safety. The initiative is being coordinated by Italy’s National Transplant Center and is an outgrowth of the EUSTITE project, which aims to optimize and harmonize the standards and methods applied in the inspection and accreditation of tissue procurement and tissue establishments within the European Union. One of the key objectives of the new initiative — titled “Vigilance and Surveillance of Substances of Human Origin,” or “V&S SOHO” — is to provide guidance and training on the investigation and management of serious adverse events associated with tissues and cells for transplantation. The project, which is funded in part by the EU Public Health Programme, also aims to increase awareness and transparency among regulators, professionals and the general public regarding risks associated with human tissues and cells and ways of mitigating them.


New AABB West Nile Virus and Chagas’ Disease Tracking Maps Add Increased Functionality for Users

In conjunction with the launch of its new website, AABB has made available new interactive maps for the tracking of West Nile virus infection and Chagas’ disease in the U.S. and Canada. In contrast to the previously static maps that were updated once per week, the new maps will be updated in real-time as data are entered into the databases of the WNV and Chagas’ disease biovigilance networks. Users can interact with the maps by, for example, adjusting date ranges and zooming in using a Google application to show more detailed location information. Through Association Bulletin #08-03, blood collection and testing facilities were informed that they should use the data from the WNV map and network reports to help determine when to change from minipool testing to individual donation nucleic acid testing for WNV. The new maps allow a faster response and greater efficiency in making that determination.


ON THE ROAD

AABB Biovigilance-Accreditation Firewall Discussed at Meeting on U.S. Biovigilance Network

AABB representatives described the firewall between the association’s biovigilance programs and accreditation department at a recent meeting of the Baltimore/Washington D.C. blood communities hosted by the American Red Cross. At the meeting — held April 2 in Washington, D.C. — they discussed how there is no information transfer between the two activities. All biovigilance-related data are fully protected and secured under AABB’s patient safety organization, Health Insurance Portability and Accountability Act business associate agreements, and confidentiality contracts. Additional information about the U.S. Biovigilance Network was provided, and attendees had the opportunity to have their questions answered. Future meetings are being planned for the Pittsburgh, Atlanta and Milwaukee areas. Facilities interested in sending representatives to these meetings or hosting a meeting in another location should contact AABB’s Center for Data and Special Programs.


IN THE NEWS

JAMA Article Highlights Hemovigilance Module

The Journal of the American Medical Association published an article in April about the CDC’s NHSN Hemovigilance Module. The article explains how the module is intended to make transfusion safer for patients. It also highlights the system’s ease of use, quoting Katharine Downes, MD, of the University Hospitals Case Medical Center in Cleveland, who said that once the hospital is using the NHSN, it takes just two to five minutes to enter data about a patient into the system. According to the article, the data collected by the system can be used by hospitals for internal quality improvement efforts and to benchmark their performance against other hospitals. It further explains that the system will allow hospitals to create reports that examine the entire institution, an individual unit, a type of blood component or a specific patient profile to identify patterns.


Scientific American Features AABB Chagas’ Disease Biovigilance Network Tracking Map

The tracking map of AABB’s Chagas’ Disease Biovigilance Network was featured in the January 2010 issue of Scientific American. The map accompanied the article, “A Plan to Defeat Neglected Tropical Diseases,” which described how several parasitic diseases, such as Chagas’ disease, are afflicting impoverished individuals in various parts of the world, including certain rural and urban areas of the U.S. The article further discusses how these diseases can be easily treated at a low cost. The map showed the numbers of blood donors testing positive for Chagas’ disease by state from 2007-09.