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Biovigilance Update - Fall 2016

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FALL 2016

IN THIS ISSUE

AABB to Present First US Hemovigilance Symposium in February »

AABB Launches Revitalized Donor Hemovigilance Program »

AABB Releases 2012-14 Donor Hemovigilance Report »

ISBT Seeks Comments on Draft Revised TACO Reporting Criteria »

AABB Posts FAQs on Participating in the Center for Patient Safety »

NATIONAL HEMOVIGILANCE

AABB to Present First US Hemovigilance Symposium in February

AABB will hold the first U.S. Hemovigilance Symposium in Atlanta on Feb. 13-14. Intended to become an annual event, the symposium will present experts from around the world to discuss the state of hemovigilance in the United States. Topics will include successes of the past decade, challenges for the future and recommendations for further progress and international harmonization. Speakers will compare current reporting methods for adverse transfusion-related events used by different hospitals in the U.S. with programs in other parts of the world. They will also address barriers to participating in hemovigilance programs. Advance registration is available through Feb. 6.


DONOR HEMOVIGILANCE

AABB Launches Revitalized Donor Hemovigilance Program

AABB is pleased to announce that the AABB Donor Hemovigilance Program will continue the important work of tracking adverse events associated with blood donation. AABB appreciates the efforts of Knowledge Based Systems Inc. (KBSI), which developed and operates the DonorHart software, to work with the blood community to enable continued program operations. AABB will reach out to current and prospective program participants, including hospital blood collectors, to provide information about the revitalized program. AABB anticipates providing benchmark reports to participants once sufficient program participation is reached.

In addition to staffing the program, AABB will continue to support donor hemovigilance education. The association encourages members to use harmonized definitions to track and report adverse donor reactions. These definitions were developed by AABB in collaboration with the International Society of Blood Transfusion and the International Haemovigilance Network.


AABB Releases 2012-14 Donor Hemovigilance Report

AABB published the 2012-2014 Donor Hemovigilance Report, which contains donor safety data reported by blood collecting organizations in the United States that provided sufficient denominator data for inclusion. The report includes information from 10 organizations reporting in 2014 and five for 2012. The data show a total of more than 1.3 million donations in 2014 and nearly 1.2 million donations in 2012.

Reaction rates were calculated as reactions per 1,000 donation procedures. The overall donor adverse reaction rate for 2014 was 22.8 reactions per 1,000 procedures. The rate for 2012 was 22.2 reactions. The most common type of reaction was vasovagal reactions, which increased slightly from 2012 to 2014 to a rate of 16.3 per 1,000 donations. Most such reactions were categorized as “prefaint,” without any loss of consciousness. The second leading type of reaction was needle-related local injury resulting in hematoma or bruise (3 per 1,000 donations).

The software used to report adverse donor events, the Donor Hemovigilance Analysis & Reporting Tool, or DonorHart, is a web-based application that facilitates reporting and analyzing data through an internet browser. DonorHart enables users to capture denominator data for donors, perform targeted analyses of reaction data and compare data from their own organization with data from other member organizations and the overall database.

In 2014, the software’s definitions for complications were harmonized with revised definitions developed by the Working Group on Donor Vigilance of the International Society of Blood Transfusion (ISBT), the Working Party on Haemovigilance in collaboration with the International Haemovigilance Network (IHN) and the AABB Donor Hemovigilance Working Group. The Donor Hemovigilance program strives to improve donor safety and safisfaction through monitoring, analyzing and researching adverse events prior to, during and following blood donations.


RECIPIENT HEMOVIGILANCE

ISBT Seeks Comments on Draft Revised TACO Reporting Criteria

The International Society of Blood Transfusion (ISBT) Working Party on Haemovigilance, in collaboration with The International Haemovigilance Network (IHN), developed revised criteria for transfusion-associated circulatory overload, or TACO. The updated criteria were developed by a revision group convened in 2013 at the request of members of the two groups. The previous criteria omitted some cases that were accepted as TACO by clinicians and several hemovigilance systems. The overall goal of the revision is to help raise awareness of TACO and improve reporting.

The proposed criteria stipulate that to be diagnosed with TACO, a patient should exhibit acute onset or worsening respiratory distress during or up to 12 hours after transfusion and evidence of two or more of four given symptoms: acute or worsening pulmonary edema, unanticipated cardiovascular system changes, fluid overload, or elevation in natriuretic peptide levels.

The revision group encourages readers to circulate this information as widely as possible. It will accept comments on the proposed revisions through Jan. 31 and consider all submission prior to validating the criteria. Comments can be submitted to Kevin Land, ISBT haemovigilance working party chair, or Jo Wiersum, TACO definition revision group.


AABB Posts FAQs on Participating in the Center for Patient Safety

AABB has released an FAQ document that answers common questions about the AABB Center for Patient Safety (CPS). The document describes the benefits of belonging to a patient safety organization, or PSO. It explains how the center protects confidential data. It also discusses the the recent Agency for Healthcare Research and Quality/Office for Civil Rights guidance on patient safety work product and providers’ external obligations and its effect on CPS participation. Finally, the FAQ answers questions related to Protected Health Information as defined by the Health Insurance Portability and Accountability Act (HIPAA).

The AABB Center for Patient Safety is a component PSO that operates independently of AABB. Founded in December 2008, the center is dedicated to providing members with confidential analysis of data on adverse reactions and incidents associated with blood transfusion. Based on these analyses, the center suggests best practices and designs interventions to improve patient safety.