Biovigilance Update - Summer 2015

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SUMMER 2015

IN THIS ISSUE

PR Symposium Highlights History, Evidence and Implementation Experiences »

Case Review of Hypotensive Transfusion Reactions Using CDC-AABB Hemovigilance Criteria »

NHSN Needs Missing Data to Complete Aggregate National Analysis »

‘Transfusion’ Article Reviews History of TRALI Research, Suggests Future Directions »

Facilities Encouraged to Join AABB Donor Hemovigilance
Program »

Hemovigilance Issues Discussed at NIH State of the Science Symposium in Transfusion Medicine »

ACBTSA Recommends Actions to Improve Tracking and Tracing of Tissue »

Article in ‘Transfusion Today’ Highlights Notify Library »

WHO Organizes First Technical Meeting for Notify Library »

Blood Collection Facilities Encouraged to Report Presumed Viremic Donations to AABB’s WNV Biovigilance Network »

TOP NEWS

PR Symposium Highlights History, Evidence and Implementation Experiences

AABB hosted a symposium on pathogen reduction (PR) technologies and their implementation on April 27-28 in Bethesda, Md. The symposium provided a platform for experts from the United States and abroad to present a range of opinions and describe experiences implementing PR technologies. Meeting participants agreed that risk-based decision making will be a key resource in providing pathways to the adoption of PR technologies. The experiences of European colleagues indicate that implementing these technologies is possible and logistically feasible. With patient safety the ultimate concern, hemovigilance must remain a critical component of transfusion medicine practice and deserves national attention as various PR implementation activities occur. In addition to safety, cost will be an important consideration in the U.S., as it is in European countries' decision making. Those in transfusion medicine face numerous choices pertaining to the adoption of PR for plasma and platelets, as well as for the future of correlated testing. Subsequent conversations on PR implementation will focus on how best to integrate decision making and policy formulation at the micro level — with company and clinical decision makers — and at the macro level, with policy makers. A sync-to-slide presentation from the symposium is available online.


RECIPIENT HEMOVIGILANCE

Case Review of Hypotensive Transfusion Reactions Using CDC-AABB Hemovigilance Criteria

Monica B. Pagano, MD, and colleagues found a number of clinical situations that are associated with hypotensive transfusion reactions. In an Early View “Transfusion” article, they report that red blood cells were implicated in 60 percent of hypotensive reactions, platelets in 11 percent and plasma in three percent. In addition, the most common clinical settings associated with these reactions are cardiac surgery, hematological-oncological diseases and general surgery. Finally, they found that in around 46 percent of cases, extracorporeal circuits had been used in the 24 hours preceding the reaction.

Pagano et al. retrospectively reviewed the medical records of 35 patients diagnosed with hypotensive transfusion at two academic medical institutions. Using criteria from the U.S. hemovigilance system — which was developed jointly by the CDC and AABB in 2010 — to define hypotensive transfusion reactions, the researchers characterized the reactions and identified associated clinical situations. The authors note that hypotension itself has a distinct pathophysiology and that the pathophysiology of hypotensive transfusion reactions has yet to be explained.


NHSN Needs Missing Data to Complete Aggregate National Analysis

The Centers for Disease Control and Prevention’s National Healthcare Safety Network, or NHSN, is currently analyzing aggregate data reported to the Hemovigilance Module for the 2013 and 2014 calendar years. To develop accurate national estimates of adverse reactions and incidents that have triggered them, the NHSN needs complete reporting of annual facility survey and monthly denominator data, adverse reactions and any incidents associated with reactions. However, some facilities have submitted incomplete data for certain key variables. As NHSN staff hope to include data from all facilities in this aggregate national analysis, they request that facilities enter any missing data from 2013 and 2014. Please contact nhsn@cdc.gov with any questions and include “Biovigilance” in the subject line for a faster response.


‘Transfusion’ Article Reviews History of TRALI Research, Suggests Future Directions

In an editorial about transfusion-related acute lung injury, or TRALI, that appears in the May issue of “Transfusion,” Mark Popovsky, MD, describes how researchers at the Mayo Clinic first characterized the syndrome 30 years ago based on observations that transfusion sometimes triggers what previously had been described as pulmonary hypersensitivity or leukoagglutinin transfusion reaction, among other names. The characterization of TRALI and a recognition of the role played by human leukocyte antigen (HLA) and human neutrophil antigen (HNA) antibodies set the stage for future research efforts. Since then, researchers have identified both patient risk factors — such as mechanical ventilation, which is associated with acute lung injury in an estimated one-third of transfused patients — and transfusion risk factors, including plasma, whole blood and volume of HLA Class II antibody and of anti-human neutrophil antigen. In addition, investigators have found a number of effective strategies to reduce TRALI, such as low-risk plasma — from male donors or females who have been screened for HLA antigens — and patient blood management approaches.

Yet despite progress in reducing the incidence of TRALI, some risk remains. Popovsky lists six questions to address in facilitating further risk reduction, although answering them is not always a simple endeavor. As he notes, even such seemingly straightforward questions such as the frequency of TRALI are complicated by the lack of a universal diagnostic framework and definitions of the syndrome. Popovsky describes two provocative articles that also appear in the May issue of “Transfusion”: one proposing two new models and another offering a novel classification scheme for TRALI. He concludes that additional approaches to TRALI may lead to new diagnostic and treatment methods for what remains a significant clinical problem.


DONOR HEMOVIGILANCE

Facilities Encouraged to Join AABB Donor Hemovigilance Program

AABB encourages blood collection facilities to join the Donor Hemovigilance Program to help reduce the number of adverse events associated with blood donation and to improve overall donor safety. Members gain access to internal benchmarking and national averages for comparison; nationally consistent definitions for adverse reactions; in-depth, expert analysis; risk mitigation; and a better understanding of rare but serious adverse donor reactions. To enroll in the program, facilities must submit an enrollment form, download the user manual and agree to adopt standard definitions or map definitions to national standards for donor reactions. AABB now offers a tiered annual pricing program to join, with discounted rates for higher numbers of blood collections.

Members report adverse donor reactions through the Donor Hemovigilance and Analysis Reporting Tool, or DonorHART, which allows users to analyze and view donor hemovigilance data. Blood center staff can enter adverse reaction reports and denominator data manually or upload .csv files. Once populated, DonorHART can generate tables, reports and graphics to show granular detail about adverse reactions and demographics and pertinent rates. Blood facilities that want to participate in donor hemovigilance, but do not yet gather all of the information used in the full DonorHART software, can enter data into a critical subset of the fields through the DonorHART Lite system. For additional information or to join the program, contact AABB's Department of Research and Data Analysis at +1.301.215.6588 or biovigilance@aabb.org.


Hemovigilance Issues Discussed at NIH State of the Science Symposium in Transfusion Medicine

Participants at the National Heart, Lung, and Blood Institute State of the Science in Transfusion Medicine symposium identified a number of hemovigilance-related questions as research priorities for the next 5-10 years. Participants in the blood donor working group recommended developing a framework to evaluate deferral policies and identify relevant risk factors among prospective donors and modifying those questions that do not contribute to blood safety. They also noted that some questions on the donor questionnaire may be unnecessary after pathogen reduction is broadly implemented. A broader scope of molecular testing for known or emerging infectious disease may also replace some questions. They suggested that it will be important to clearly define terms, such as “tolerable risk” and “as low as reasonably achievable.”

With regard to red blood cells, participants discussed which contextual factors affect immune response and the risk of infectious disease after transfusion. They remarked that these factors should be incorporated into the alloimmunization concept, which has been broadened to include the basic biology of immunology of red blood cell transfusion. Finally, participants noted the need for research on pathogen inactivation as it relates to platelets. The symposium was part of the NHLBI’s Strategic Visioning process to identify the most compelling questions in transfusion medicine and critical challenges to achieving the institute’s goals — promoting human health, reducing human disease, advancing translational research and developing the workforce and resources.


BIOVIGILANCE

ACBTSA Recommends Actions to Improve Tracking and Tracing of Tissue

The Advisory Committee on Blood and Tissue Safety and Availability, which met on April 7-8 in Rockville, Md., heard a wide array of presentations about tissue safety, highlighting recent progress as well as gaps in tracking, traceability and informed consent. Committee members voted unanimously to recommend that the secretary of the U.S. Department of Health and Human Services adopt a step-wise, risk-based approach to standardizing the identification, tracking and tracing of medical products of human origin. In particular, the committee recommends establishing ISBT 128 labeling as “a universal standard for mandatory implementation of unique donation identifiers for all human tissue products.” It suggests that the secretary promote the integration of transplantation records into searchable, electronic patient records. It further recommends taking steps to ensure that patients are informed when they receive a tissue product and provided a means of tracing it. The committee asks that the secretary promote education for health care providers regarding the risks of human tissue transplants, the need for meaningful informed consent and the necessity of engaging in activities to ensure tracking and tracing of tissue products. Lastly, it notes the importance of promoting international collaboration and data sharing on outcomes of tissue transplantation. Recommendations from the meeting are posted online, and a webcast is expected to be available soon on the committee’s website.


Article in ‘Transfusion Today’ Highlights Notify Library

An article in the March issue of the International Society of Blood Transfusion’s journal, “Transfusion Today,” highlights the Notify Library, a database of adverse events resulting from medical products of human origin, or MPHOs. MPHOs include all human-derived biological substances, both autologous and donated, and all materials processed into pharmaceuticals — such as immunoglobulins — and cellular therapies. The database currently contains events related to organs, tissues and cells, although events related to transfusion will be added in the future.

Created through a collaboration between the Italian National Transplantation Centre, the World Health Organisation and a partner in the European Union-funded “Substances of Human Origin Vigilance and Surveillance” project, the database’s goal is to provide health professionals and authorities an overview of adverse events resulting from each type of MPHO so they can take steps to protect patient safety. The database is freely available to the general public, as well. Each adverse reaction, error or incident in the database has been analyzed by international experts and paired with a key learning point. The events come from articles in scientific journals and from recognized biovigilance organizations and reporting systems.


WHO Organizes First Technical Meeting for Notify Library

The Notify Library supports the sharing of published biovigilance information to educate and provide transparency on adverse incidents associated with Medical Products of Human Origin (MPHO). In 2015, the Spanish Organization of Transplantation and the Catalan Transplant Organization joined the project and organized a technical meeting for editorial working group members in February 2015 in Barcelona. During the meeting, much progress was achieved on a range of issues. The meeting organizers presented a new library tutorial and website with a tool that uploads new database records directly. Meeting participants experienced the new functionality of the database and discussed unusual cases. In addition, the participants drafted a strategic plan on the inclusion of adverse occurrences and adopted the database taxonomy for adverse transfusion reactions and adverse blood donor reactions to allow the incorporation of hemovigilance records into the database. At the end of the meeting, more than 1,100 records became public in the database. Records are linked to more than 2,000 articles and adverse reaction reports from competent authorities and scientific journals and societies.


TRANSFUSION-TRANSMITTED INFECTIONS

Blood Collection Facilities Encouraged to Report Presumed Viremic Donations to AABB’s WNV Biovigilance Network

As warm weather returns to many areas of the U.S., AABB encourages blood collection facilities to report all presumed West Nile virus-infected donations to AABB’s West Nile Virus Biovigilance Network. According to the CDC, a total of 47 states and the District of Columbia reported WNV infections in people, birds or mosquitoes in 2014, including 2,122 cases of human WNV infections. During 2014, there were 303 confirmed WNV viremic donations reported to the AABB WNV Biovigilance Network and 22 suspected cases pending interpretation.

The network, launched in 2006, collects and collates data on donors with suspected WNV infection in the U.S. and Canada. Created by the AABB WNV Task Force, the network is intended to support and enhance a tracking initiative developed by AABB in partnership with FDA and CDC. AABB Association Bulletin #13-02 recommends that blood collection and testing facilities 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 map and charts are updated in real time as data are entered into the system. Facilities are encouraged to review and update their contact information for notification in the case of individual donor nucleic acid testing triggering in their area. Those interested in receiving alerts when entries are made to the network can register by sending a message that includes their contact information to hemovigilance@aabb.org.