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Biovigilance Update - Winter 2013 

 Visit aabb.org/biovigilance

WINTER 2013

IN THIS ISSUE

International Hemovigilance Network Holds 15th Annual Symposium »

Summary Available of Substances of Human Origin Project Final Conference »

Reminder: Hospitals Encouraged to Inform AABB of Their Participation in NHSN Hemovigilance Module »

Study Identifies Risk Factors for TACO »

CDC Releases Updated NHSN Hemovigilance Module Protocol »

CDC to Hold Bi-Monthly NHSN Hemovigilance Module Webinars »

AABB Now Accepting Abstract Submissions for Its 2013 Annual Meeting & CTTXPO »

AABB Audioconferences Highlight Hemovigilance Activities »

Reminder: Blood Collection Facility Personnel Encouraged to Undergo Donor Hemovigilance System Training »

JAMA Article Urges Enhanced Tissue Tracking; Acknowledges AABB Efforts in Blood Tracking Systems »

India Launches National Biovigilance Program »

AABB Participates in Chinese Blood Services Leadership Program »

TOP NEWS

International Hemovigilance Network Holds 15th Annual Symposium

The International Hemovigilance Network, or IHN, held its 15th annual symposium in Brussels Feb. 20 to 22. At the meeting, a comprehensive report of Belgian national hemovigilance activities was given and a session devoted to hemovigilance in developing and transitional countries was offered. There were a record number of sessions on donor vigilance.

Michael Murphy, MD, FRCP, FRCPath, of the John Radcliffe Hospital in Oxford, who also serves on the AABB Board of Directors, presented the "Recipient Haemovigilance: State of the Art" lecture. Constantina Politis, MD, was presented the IHN Award for her contributions to hemovigilance in Greece and internationally and for the establishment of the International Surveillance of Transfusion-Associated Reactions and Events, or ISTARE, database, which tracks transfusion and donation reactions and events. ISBT Secretary-General Paul Strengers, MD, FFPM, was presented the IHN Medal for his numerous contributions to the activities of the network.

AABB's Donor Hemovigilance Working Group presented a poster titled "Delayed and Immediate Vasovagal Reaction Characterization." The poster provided an analysis of factors associated with vasovagal reactions that occur in different stages. The data presented were from the U.S. Donor Hemovigilance System pilot program.


Summary Available of Substances of Human Origin Project Final Conference

A statement summarizing the final conference of the Vigilance and Surveillance of Substances of Human Origin Project is now available. The meeting, held Feb. 18 to 20 in Surrey in the United Kingdom, provided guidance and training on the investigation and management of serious adverse reactions and events associated with tissues and cells for transplantation. Specific topics included how best to engage clinicians in vigilance reporting and investigation, approaches and methodologies for serious adverse incident investigations, and how to improve urgent communication internationally. A key achievement of the program is the development of several guidance documents, such as one on vigilance and surveillance activities for living donors. Four guidance documents can be downloaded as a single booklet from the project's website. Those who attended the conference can download the meeting presentations from the restricted area of the site. Individuals with questions may email Deirdre Fehily, PhD, inspector and technical adviser – tissues and cells, and technical coordinator of the Vigilance and Surveillance of Substances of Human Origin Project at the Italian National Transplant Center.


RECIPIENT HEMOVIGILANCE

Reminder: Hospitals Encouraged to Inform AABB of Their Participation in NHSN Hemovigilance Module

Hospitals are encouraged to inform AABB of their participation in the Hemovigilance Module of the Centers for Disease Control and Prevention's National Healthcare Safety Network. CDC does not identify participating institutions due to the confidentiality rules to which it must adhere. However, hospitals may choose to publicize their participation in this quality program. Those that identify themselves to AABB will be invited to join AABB's Hemovigilance Module Transfusion Safety Group. Staff of AABB's Patient and Donor Safety Center, or PDSC, working with volunteer experts, will analyze the group's hemovigilance data with the goal of developing interventions that will improve patient safety.

For hospitals already participating in the NHSN, there only are a few steps required to join AABB's Hemovigilance Module group. Interested facilities should contact AABB's Patient and Donor Safety Center at +1.301.215.6588 or by email to inform the association of their participation in the module and interest in joining AABB's group.


Study Identifies Risk Factors for TACO

A study published in "The American Journal of Medicine" identified several risk factors for transfusion-associated circulatory overload, or TACO. The researchers determined, as previous studies have found, that an increase in the number of blood products transfused and "physiologic measurements indicative of pre-existing volume overload" (such as a positive fluid balance) are associated with an increase in the risk of TACO. They further found that pre-existing congestive heart failure and chronic kidney disease also increase the risk of TACO. The authors concluded that the study's results, if repeated in other investigations, "could be used to construct predictive algorithms for [TACO], and subsequent modifications of transfusion practice might prevent morbidity and mortality associated with this complication." The authors also noted that the incidence rate of TACO as determined through biovigilance data tends to be much lower than the rate as determined through retrospective and prospective cohort studies and that the severity of the morbidity and mortality associated with TACO is underestimated.


CDC Releases Updated NHSN Hemovigilance Module Protocol

The Centers for Disease Control and Prevention has released version 2.0 of the protocol for the National Healthcare Safety Network's Hemovigilance Module. The agency announced that as a result of the feedback it received from system users, it has simplified the module's reporting requirements. As of January 2013, users are only required to report incidents related to adverse reactions; comprehensive incident reporting is no longer required. However, hospitals already have benefited from the analysis of reported incident data, and AABB's Patient and Donor Safety Center, or PDSC, members have committed to ongoing reporting of these events in order to advance important process improvements and enhance patient care. AABB's PDSC will continue to analyze these incident data and share the results with its members.

All adverse reaction case definition criteria tables have been revised for easier use and some case definitions and imputability criteria have been modified. Individuals with questions regarding these changes or who would like to participate in the Hemovigilance Module may email the CDC or visit the agency's website. For more information about AABB's Patient and Donor Safety Center and benchmarking activities, contact Barbee I. Whitaker, PhD, director of the center, at +1.301.215.6574 or by email.


CDC to Hold Bi-Monthly NHSN Hemovigilance Module Webinars

The CDC will hold bi-monthly webinars covering various topics related to NHSN Hemovigilance Module data reporting, such as adverse event reporting and data sharing using the group function. The first webinar was held Feb. 13, covering version 2.0 of the Hemovigilance Module protocol. Those interested in registering for future sessions should visit the NHSN website. Individuals with questions should send an email to the CDC with the subject line, "Biovigilance Component."


AABB Now Accepting Abstract Submissions for Its 2013 Annual Meeting & CTTXPO

AABB individual members now can submit abstracts to be considered for presentation at the 2013 Annual Meeting & CTTXPO in Denver. Entries will be accepted through May 8. This year's categories and submission guidelines are available on the AABB website. Authors of abstracts selected for presentation will be notified by June 24. Questions regarding the 2013 abstract program should be directed to AABB's Education and Professional Development department.


AABB Audioconferences Highlight Hemovigilance Activities

AABB recently conducted two audioconferences on hemovigilance activities. A Jan. 16 session, titled "Hemovigilance Report Generation and Analysis: How to Make the Most out of Your Data," reviewed data set generation, analysis and reporting from the NHSN Hemovigilance Module. It also covered how to use data from the Hemovigilance Module as a learning tool. A Feb. 6 audioconference, titled "Blood Center's Role in the Management of Recipient Adverse Events," provided a general overview of the role of blood centers in the investigation of these types of events. Recordings of these audioconferences are available online.


DONOR HEMOVIGILIANCE

Reminder: Blood Collection Facility Personnel Encouraged to Undergo Donor Hemovigilance System Training

Blood collection facility personnel are encouraged to participate in training for the U.S. Donor Hemovigilance System. The system is helping participating facilities track and reduce the occurrence of adverse events by allowing the establishments to enter data related to donor reactions into a Web-based electronic data collection and analysis tool. The system has sufficient flexibility to accommodate different data-entry methods and allows for partial data submission. Enrollment materials, including training documents, are available on the AABB website.


TISSUE BIOVIGILANCE

JAMA Article Urges Enhanced Tissue Tracking; Acknowledges AABB Efforts in Blood Tracking Systems

An article in "The Journal of the American Medical Association" points out a regulatory gap in tissue tracking requirements and recommends action by the Food and Drug Administration. Authors John DePaolo and James Barbeau note that the FDA requires tissue banks to track tissues from the donor to the consignee or final disposition, but hospitals are exempt from this requirement. The article highlights deficiencies in the tissue tracking requirements that have led to several cases of infectious disease transmission. The authors acknowledge AABB and the American Association of Tissue Banks for working to implement ISBT-128 labeling — a standardized system widely used in the blood banking, tissue and cellular therapies industries — through their voluntary standards and accreditation programs. A preview of the article is available to the public; the full version may be accessed by JAMA subscribers.


INTERNATIONAL BIOVIGILANCE

India Launches National Biovigilance Program

India's National Institute of Biologicals, in collaboration with the Indian Pharmacopoeia Commission, launched a national biovigilance program in December 2012, according to an article posted on Pharmabiz.com. Among its activities, the Biovigilance Program of India will track adverse events and incidents associated with blood transfusion, tissue and organ transplantation, and cell therapies. The program will be used to help identify trends, best practices and interventions that may help improve patient care and safety, while also reducing the cost of health care. Sixty medical colleges were enrolled as of early January 2013.


AABB Participates in Chinese Blood Services Leadership Program

AABB recently participated in the "Education Course for Leadership of Blood Services," a comprehensive program designed to help blood bank leaders in China advance their skills in management and technology. During the program — which has been cosponsored by the Chinese Society of Blood Transfusion, Shanghai Blood Center, International Society of Blood Transfusion, the World Health Organization and AABB for six years — Barbee I. Whitaker, PhD, director of AABB's Patient and Donor Safety Center, gave an overview of the history of hemovigilance and how the initiative expanded into biovigilance. Whitaker provided details on how hemovigilance programs in the U.S. and Europe developed. In particular, she highlighted recipient and donor hemovigilance and tissue biovigilance in the U.S. and lessons learned from U.S. and European vigilance and surveillance activities. For more information on hemovigilance and biovigilance, individuals should contact AABB's Patient and Donor Safety Center at +1.301.215.6588 or by email.


Correction: In a previously posted version, Paul Strengers, MD, FFPM, was described as ISBT president. He is secretary-general of ISBT.
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