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Biovigilance Update - Spring 2016




New PSO Portal Goes Live »

AABB Distributes Blood Utilization Benchmark Report From 2013 Blood Survey »

CDC Updates for Hemovigilance Module of NHSN’s Biovigilance Component, Clinical Documentation Architecture »

Red Blood Cell Alloimmunization Associated With Adverse Outcomes in Patients With Sickle Cell Disease »

Researchers Predict Vasovagal Reactions Based on Donor Self-Report of Fear, Total Blood Draw Time »

AABB Releases Association Bulletin With Updated Zika Virus Information »

FDA Publishes Donor Screening Recommendations to Reduce Risk of Transmission of Zika Virus by HCT/Ps »

AABB Collaborating With Federal Agencies in Advance of Local Transmission of Zika Virus »

IHN Symposium Features a Variety of Topics in Hemovigilance »

Peter Tomasulo, Luc Noël Honored at IHN Symposium for Contributions to Hemovigilance »

ICCBBA Presents 2016 One World Award to Rodeina Davis »


New PSO Portal Goes Live

The AABB Center for Patient Safety, a component Patient Safety Organization (PSO), has introduced the Hemovigilance Portal to enhance functionality and provide additional support for members. The AABB Center for Patient Safety supports members with their hemovigilance activities in a variety of ways. Members gain access to benchmark reports, PSO teleconferences, and submit supplemental data. They can also participate in Safe Tables, where individuals can confidentially and freely discuss adverse events from their institution and learn from others in a supportive environment. Questions and requests to apply for membership may be directed to +1.301.215.6588 or

AABB Distributes Blood Utilization Benchmark Report From 2013 Blood Survey

In March, AABB provided blood utilization benchmark reports to member hospitals in the United States that participated in the 2013 AABB Blood Survey. The report compares hospital transfusion, outdate and wastage rates for major components with rates reported by other hospitals with similar surgical volumes and with the average utilization rates of AABB member institutions in the U.S. If you have any questions about the reports, please contact

CDC Updates for Hemovigilance Module of NHSN’s Biovigilance Component, Clinical Documentation Architecture

In response to user requests and feedback, CDC is developing Clinical Documentation Architecture (CDA). CDA will allow NHSN-Biovigilance users to upload denominator data to the Hemovigilance Module without manual data entry. CDA will decrease the reporting burden, improve data quality and increase data granularity allowing for rate calculations by product type and combinations of collection method or modification. Users with Health Level 7 (HL7) membership may download the CDA Implementation Guide from the HL7 website. All others will be able to access the HL7 CDA Release 2 Implementation Guide: Healthcare Associated Infection Reports, Release 3, DSTU Release 1 - US Realm on the CDC website by late May. CDC will host a webinar this summer with further details.

The Centers for Disease Control and Prevention reminds individuals to complete their Annual Facility Survey. Surveys are supposed to be completed during January, and CDC urges those that have not yet completed them for their facility to do so as soon as possible. The report provides CDC with facility and transfusion services characteristics. CDC uses these descriptive data to provide context for aggregated national analysis.

CDC also reminds facilities to begin addressing any missing data for 2015. Individuals can see when they log into the Biovigilance Component Home Screen. Those with questions and feedback are asked to contact and include ‘Biovigilance’ in the subject line for the fastest response.


Red Blood Cell Alloimmunization Associated With Adverse Outcomes in Patients With Sickle Cell Disease

Red blood cell alloimmunization may lead to myriad adverse outcomes in patients with sickle cell disease, including delayed medical care, higher medical costs, and an increased risk of morbidity and mortality, according to the results of a study published in “Transfusion” in January.

The findings were based on case reports of five patients with sickle cell disease, all of whom had died. All five patients experienced red blood cell alloimmunization. According to the authors, the case reports offer insight on the “direct and indirect consequences of red blood cell alloimmunization,” particularly since all five patients experienced delayed hemolytic transfusion reactions or did not receive needed red blood cell transfusions. In several cases, red blood cell transfusions were delayed or did not occur because there were difficulties in obtaining compatible blood.

The researchers said these findings offer further evidence that mortality risk may be increased for patients with sickle cell disease who experience red blood cell alloimmunization compared with patients who do not.

The researchers concluded that the data indicate that as life expectancy for people with sickle cell disease continues to increase, the health impact of red blood cell alloimmunization merits more attention. “Additional research on the biology underlying red blood cell alloimmunization is needed to help develop new therapies to mitigate the dangers of this complication,” the authors wrote.


Researchers Predict Vasovagal Reactions Based on Donor Self-Report of Fear, Total Blood Draw Time

A study published in “Transfusion” provides evidence that both fear and length of blood draw contribute significantly to vasovagal reactions in donors. Vasovagal reaction rates increased with blood draw time, with reaction rates doubling from the shortest (less than six minutes) to the longest (more than 10 minutes) times. Researchers found that combining the effects of blood draw times with fear of blood draws improved predictions of vasovagal reaction. “Specifically, in this study fear of blood draws predicted an approximate threefold increase in the odds of experiencing a vasovagal reaction at each draw duration level examined, and these effects persisted after controlling for donor sex, weight, estimated blood volume, pulse rate, and first-time donation status.”

Researchers analyzed data from a routine predonation health screen of 2730 high school-age whole blood donors. In addition to standard health screen questions (age, sex, weight, number of prior donations, etc.), the students were asked to rate, in writing, their fear of having blood drawn on a five-point rating scale, in which a rating of one indicated “not afraid at all” and five meant “extremely afraid.” Phlebotonists, who were blind to the donors’ fear level, reported degree of donor reaction (none, mild, moderate or severe) and location where the reaction occurred.

According to the study’s authors, the findings indicate that donors — particularly those who are young or inexperienced — should be screened routinely for fear of donation. In addition, phlebotomists should give fearful donors special attention to reduce their predonation distress and educational materials emphasizing that the same amount of blood is drawn from all donors and that varying draw times are normal. The researchers also recommend careful observation during donation and greater attention postdonation to mitigate the risk of a delayed reaction. They call for further studies with larger and more diverse donor populations to replicate and extend the findings and to test specific interventions.


AABB Releases Association Bulletin With Updated Zika Virus Information

AABB released Association Bulletin (AB) #16-04 to provide updated information on the ongoing outbreaks of Zika virus infection in Mexico, the Caribbean, Central and South America and other regions around the world. The bulletin follows the release of the Food and Drug Administration’s guidance document, “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus.” AB #16-04, which supersedes AB #16-03, provides information and recommendations consistent with those in the FDA guidance. Although the FDA guidance contains recommendations that apply to areas both with and without active Zika virus transmission, the bulletin focuses on blood collection activities in areas without active transmission. The Centers for Disease Control and Prevention keeps an up-to-date Web page, Areas with Zika, listing areas with active Zika virus transmission; AABB encourages interested individuals to consult this resource daily to keep apprised of the virus’s rapid spread. Although the bulletin focuses on Zika virus, the measures described also apply to chikungunya and dengue viruses.

AB #16-04 contains informational materials for blood centers and prospective donors on the potential for transfusion-transmitted Zika virus. It also describes symptoms consistent with acute tropical infections. The bulletin recommends adding a question to the additional questions area of the Donor History Questionnaires (DHQs) about recent travel to, or residency in, an area with active Zika virus transmission. It also provides recommendations for implementing a four-week self-deferral for donors who have returned from areas with active Zika virus transmission; those diagnosed or experiencing symptoms consistent with Zika virus infection; and those potentially at risk for sexual transmission of the virus. Finally, the bulletin offers educational self-deferral sheets and post-donation information (PDI) materials relevant to Zika, chikungunya and dengue viruses and recommendations for their use, including recommended blood center and transfusion service actions in response to PDI reports.

FDA Publishes Donor Screening Recommendations to Reduce Risk of Transmission of Zika Virus by HCT/Ps

The FDA published a final guidance containing recommendations for establishments that make eligibility decisions for prospective donors of human cells, tissues and cellular and tissue-based products (HCT/Ps). The guidance, which supplements the August 2007 guidance, “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products,” identifies Zika virus as a relevant communicable disease agent or disease and is meant for immediate implementation. It highlights the potential risk of transmission of Zika virus by HCT/Ps, including hematopoietic stem or progenitor cells from cord and peripheral blood, corneas, bone, skin and heart valves. FDA recommends completing a medical record review for all prospective donors to confirm that they are free from risk factors for, or clinical evidence of, Zika virus infection. Risk factors include any of the following within the past six months: a medical diagnosis of Zika virus infection; residence in, or travel to, an area with active Zika virus transmission; or sexual relations with a male who meets either of these criteria. There are different recommendations for living and cadaveric HCT/P donors. FDA recommends implementation as soon as feasible but no later than four weeks after the issue date.

AABB Collaborating With Federal Agencies in Advance of Local Transmission of Zika Virus

While confirmed cases of Zika virus in the U.S. have been associated so far with travel to areas with active Zika virus transmission, AABB continues working with federal agencies to develop a contingency plan for expected local transmission of the virus in the U.S. In addition to publishing recommendations to help decrease the risk of transfusion-transmitted Zika virus, organizing work groups and planning educational workshops, the association is engaged in ongoing conversations with the CDC and FDA to refine the definition of “area of active Zika virus transmission.” It is also working to develop a rapid and efficient communication plan to notify blood establishments when an area is determined to have active transmission.

Such a plan is important not only so blood collectors know when to cease collections in affected areas but also so donors in non-affected areas are educated appropriately before travel to areas with active transmission. The process will begin when local and state health officials report active Zika virus transmission to the CDC, which then will incorporate the information into the CDC website, as identified in the FDA guidance document. The CDC maintains an up-to-date map of areas around the world with active mosquito-borne transmission of Zika virus. AABB will continue to update members as this process progresses. The Association is reviewing options to provide information via AABB web-based resources to assist in donor and product management if — and when — areas of active Zika virus transmission are identified in the U.S.


IHN Symposium Features a Variety of Topics in Hemovigilance

The 17th International Haemovigilance Symposium, held last month in Paris, included sessions on hemovigilance in Europe, Africa and countries around the world, including the United States, Brazil and India. The opening session, chaired by Erica Wood, MBBS, FRACP, FRCPA, president of the International Haemovigilance Network (IHN), and Pierre Tiberghien, MD, PhD, highlighted achievements and lessons in hemovigilance from the past 20 years. Plenary sessions addressed inflammation and its implications for blood donors and transfused patients; sickle cell disease and hyperhemolysis; iron; and hemovigilance in Africa. Other sessions highlighted tools for practice improvement, including simulation training, horizon scanning and database and registry data, and microbiological hemovigilance. Donor hemovigilance sessions addressed vasovagal reactions, young donors and delayed reactions, while recipient hemovigilance sessions focused on human factors and transfusion error, transfusion-associated circulatory overload (TACO) and fatal reactions reported to the INH’s international database, the International Surveillance of Transfusion-Associated Reactions and Events, or ISTARE. Power Point slides from the presentations are available on the program page of the IHN website.

Peter Tomasulo, Luc Noël Honored at IHN Symposium for Contributions to Hemovigilance

Erica Wood, MBBS, FRACP, FRCPA, IHN president, presented awards to hemovigilance experts Peter Tomasulo, MD, and Luc Noël, MD, at the recent IHN Seminar in Paris. Tomasulo received the 2016 IHN Medal for extraordinary contributions to the work performed by the IHN. He serves on the “Transfusion” editorial board and previously chaired the AABB Donor Hemovigilance Working Group. In addition, Tomasulo has worked at numerous blood centers, including the American Red Cross, Blood Systems Inc. and the International Federation of Red Cross and Red Crescent Societies. He is well known for his contributions to blood donor safety.

Noël received the 2016 IHN Award to recognize his significant contributions to hemovigilance and the broader field of biovigilance. Noël worked at the World Health Organization from 1999, when he began serving as coordinator of Blood Transfusion Safety, until his 2014 retirement. In 2004, he was appointed coordinator for the Clinical Procedures unit, where his work on transplantation was incorporated into the WHO’s revision of the Guiding Principles for Human Cell, Tissue and Organ Transplantation. A founding developer of the Notify Library, Noël has been instrumental in promoting the ethical use of Medical Products of Human Origin.

ICCBBA Presents 2016 One World Award to Rodeina Davis

ICCBBA announced that Rodeina Davis has been chosen to receive its 2016 One World Award, acknowledging her contributions to the understanding and application of transfusion information standards. An information technology professional, Davis was the principal investigator in a study implementing the use of Radio Frequency Identification (RFID) technology in transfusion medicine. Davis received the AABB President’s Award in 2010 for this work. In addition, she served as a member of the AABB Biovigilance Recipient System Working Group from 2006-2011, as well as on the Executive Council for the International Society for Blood Transfusion (ISBT) Information Technology Working Party and the ISBT Validation Task Force. Davis co-chaired ISBT task forces to develop the guidelines for RFID and for information security in transfusion medicine.