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Biovigilance Update - Winter 2015-16


WINTER 2015-16


AABB Releases Results of 2013 Blood Survey Report »

National Healthcare Safety Network Updates Hemovigilance Module for 2016 »

Future Enhancements to the National Healthcare Safety Network Hemovigilance Module »

Notices from CDC regarding Hemovigilance Reporting »

Hemovigilance Workshop in Anaheim »

Report Summarizes 2015 SHOT Symposium, 2014 SHOT Report »

Results of ‘STRIDE’ Study Presented at Annual Meeting »

2015 AABB Annual Meeting Education Sessions Feature Donor Hemovigilance »

NOTIFY Project Supports Global Vigilance and Surveillance Activities »

Neglected Tropical Diseases Becoming Endemic in US »

Zika Reported in Puerto Rico; Concerns Grow Over Possible Link to Microcephaly »


AABB Releases Results of 2013 Blood Survey Report

AABB published a report on the results of the 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey (the Blood Survey). The report provides data on the blood collection and utilization practices of AABB member facilities between Jan. 1, 2013 and Dec. 31, 2013. The report also offers patient blood management (PBM) benchmarks, including implementation data and transfusion thresholds. It includes trends in areas with sufficient data to facilitate comparisons with previous United States federal blood surveys conducted by AABB.

Overall, more than half of AABB member blood collectors, hospital transfusion services and centralized transfusion services responded to the survey, with 92 percent of blood centers providing data. This high response rate enables comparisons of data from the 2013 Blood Survey with that from AABB member hospital responses in the 2011 National Blood Collection and Utilization Survey.

Results from the survey show significant decreases in total whole blood allogeneic blood collections and red blood cell collections. Likewise, 2013 saw fewer allogenic blood donors and donations. Plasma collections declined, as well. In contrast, the number of apheresis platelet donations in 2013 was similar to the number in 2011. The total numbers of transfused whole blood and red blood cell units declined, as did the number of transfused plasma units. However, the number of transfused apheresis platelets increased. Extrapolating from the data, the overall rate of transfusion in the U.S. is an estimated 40.3 units per 1,000 individuals of all ages.

More than half of AABB member hospitals report implementing aspects of patient blood management into their transfusion practice, with more than 1/3 having a PBM program and nearly 1/4 having implemented five or more PBM interventions.


National Healthcare Safety Network Updates Hemovigilance Module for 2016

Beginning in January 2016, the Hemovigilance Module Denominator reporting form includes a new section where users can report the total numbers of units and aliquots produced with pathogen-reduction technology (PRT). Users should enter units and aliquots transfused by product type and collection method, as they do in the previous denominator form table. Users will report PRT units as a subset of the total number of units and aliquots transfused. New training materials include a brief QuickLearn tutorial to guide users through these reporting changes.

The reporting process for pooled platelet and cryoprecipitate products changed in January, as well. Users should report individual units instead of pools to ensure consistent and reliable data analyses. The table of instructions for the denominator form describes how users should report pooled products.

Future Enhancements to the National Healthcare Safety Network Hemovigilance Module

In response to user requests and feedback, CDC has started to develop Clinical Documentation Architecture (CDA) for the Hemovigilance Module Denominator form. CDA will allow NHSN users to upload denominator data to the Hemovigilance Module without manual data entry. The CDA Implementation Guide will be available in the spring of 2016 to assist blood bank software developers in incorporating NHSN specific CDA for their software. According to the agency, CDA will decrease the reporting burden, improve data quality and significantly increase data granularity allowing for rate calculations by product type and combinations of collection method or modification. CDC is working to increase awareness about the CDA Implementation Guide among blood bank software vendors.

Notices from CDC regarding Hemovigilance Reporting

As 2016 begins, CDC reminds facilities to begin addressing any missing data for the 2015 reporting year. Users can check the alerts on the Biovigilance Component home screen to see what data is missing. Questions and feedback may be sent to; please include ‘Biovigilance’ in the subject line for the fastest response.

When a patient experiences two reactions, users should report both reactions in separate adverse reaction reports. This applies whether the patient receives one or multiple units. Questions about a specific case can be directed to with “Biovigilance” in the subject line.

All Hemovigilance Module forms can be customized for local use from the forms available on the CDC website. Users can download Word files and incorporate Hemovigilance Module forms into their facility’s internal data collection process.

Hemovigilance Workshop in Anaheim

The preconvention workshop, Introduction to Hemovigilance, provided an overview of national and international systems, a review of key definitions (including TRALI and TACO) and a discussion on the data needed for hemovigilance reporting. The workshop also included a description of the AABB Center for Patient Safety (CPS), which currently has more than 100 participating hospitals, representing more than 750,000 transfusions annually. Enrolled facilities, which upload data on adverse events, receive benchmarking reports on hemovigilance, access to educational audioconferences and in-depth feedback through “safe table” conference calls to review data and address coding issues. The CPS ensures members confidentiality in reporting patient information without concern for legal liability or professional sanctions.

Report Summarizes 2015 SHOT Symposium, 2014 SHOT Report

The British Blood Transfusion Society published a conference report in its journal, “Transfusion Medicine.” The report summarizes the 2015 Serious Hazards of Transfusion, or SHOT, symposium held in June and the 2014 Annual SHOT Report presented there. The report, which is available on the SHOT website, describes adverse transfusion events reported to the United Kingdom’s national hemovigilance program. It includes aggregate reporting of errors and near misses in addition to transfusion reactions. In addition, the SHOT Report provides two recommendations: (1) a TRALI recommendation to manufacture cryoprecipitate from male donors when possible and (2) to provide transfusions with the same attention to patient observations whatever the time of day or night; transfusions may occur at night when necessary and appropriate (reversing the previous recommendation against nighttime transfusions).

The report lists 15 transfusion-associated deaths in 2014 in the U.K., down from 22 in 2013. Of those, six were due to transfusion-associated circulatory overload (TACO), three to transfusion-associated dyspnea, two to transfusion-related acute lung injury and one to hemolytic transfusion reaction. During the past five years, TACO has been responsible for the highest number of transfusion-related deaths.

With respect to all reported adverse transfusion events, the majority — 78 percent — resulted from human error. Multiple errors often occurred during a single transfusion; the report states that the transfusion process consists of nine separate steps that are frequently performed by different health care workers. The report supports checklists as one way to reduce human error but recommends training staff in “resilience” — the intrinsic ability for a system to adjust its functioning before, during and after changes and disturbances — as a better way for the health care system to make transfusion even safer.


Results of ‘STRIDE’ Study Presented at Annual Meeting

Results from the two-year, randomized, placebo-controlled “Strategies To Reduce Iron Deficiency” (“STRIDE”) study were presented in two oral abstract sessions at the 2015 AABB Annual Meeting. Ritchard Cable, MD, discussed findings on donor behavior during the plenary oral abstract session. Specifically, he reported that donors with low ferritin levels — 26 µg per liter or less — were more likely to take an iron supplement and less likely to delay their next donation when they received a letter that informed them of their low iron level and recommended an iron supplement and/or delaying their next donation. Alan Mast, MD, PhD, presented donor iron status data in another session. Mast reported that the prevalence of donors with low ferritin levels decreased by more than 80 percent when they received iron supplements in either 19 or 38 mg doses. These and other findings from the “STRIDE” study are available in an AABB Annual Meeting News Blog posting from the meeting.

2015 AABB Annual Meeting Education Sessions Feature Donor Hemovigilance

Experts addressed many aspects of hemovigilance during the 2015 AABB Annual Meeting. The issue of iron depletion came up during the Hot Topic session, “Management of Blood Donor Iron Depletion.” During this session, speakers considered whether and how blood centers should manage donor iron levels. Following presentations on the latest research findings, an assembled panel responded to questions on how to tackle the issue with donors. Evidencing the lack of consensus on the issue, panelists disagreed on whether or not blood centers are obliged to provide donors with iron supplements or even to encourage their use. The results of the Strategies To Reduce Iron Deficiency' (STRIDE) study, discussed elsewhere in this issue, were presented in two oral abstract sessions at the meeting.

With respect to donor hemovigilance, the educational session “Managing Donor Adverse Events in the Young Donor Population” discussed the ways in which teenage blood donors differ from adults. Specifically, young donors reportedly view donating blood as a sign of maturity and benefit from learning about the donation process and the need for blood. Session speakers described steps blood centers have taken to reduce the risk of reactions in young donors. These include giving them rubber bracelets so school nurses and teachers can monitor them for signs of delayed reactions, setting up floor mats and hydration stations and encouraging prospective teen donors to drink water and eat a snack prior to donating. According to speaker Thomas Watkins, DO, PhD, “Anything that we can do to make things safer ultimately lowers costs, it promotes better donor experiences, it encourages future donations, and I think that’s crucial in young donors.”


NOTIFY Project Supports Global Vigilance and Surveillance Activities

The NOTIFY Library facilitates the sharing of published biovigilance information to educate and provide transparency on adverse occurrences associated with Medical Products of Human Origin (MPHO). Since the first technical meeting of the Editorial Groups took place in Barcelona last February, the number of records published in the NOTIFY Library has greatly expanded. More than 350 records have been published during the last eight months. The records fall into the following categories: 189 records in the “Clinical complication group” (mostly blood related), 78 records of “Infection transmissions,” 30 records of “Living donor reactions,” 34 records of “Malignancy transmissions” and 19 “Process-related” adverse event records. Infection group records include 26 related to bacteria, one fungal, 17 parasitic, two prion and 32 viral.

As of November 2015, there were 1,467 “Adverse occurrences” that had been entered in the library. Those occurrences are linked to 2,240 bibliographic references. Specialists have reviewed each case and provided comments, establishing a high level of didactic value for other professionals. To facilitate a structured database search, all blood related records have been classified according to an extended taxonomy. The taxonomy is divided into two main groups: adverse occurrence type and MPHO type. These groups are further subdivided. A gap analysis is underway to determine missing elements.

The results of the Editorial Groups’ work were presented at the NOTIFY Project strategic meeting on Dec. 1-2 in Bologna. Meeting participants were tasked with developing a strategic plan for worldwide vigilance and surveillance of MPHO using the NOTIFY Library’s resources. The optimization and dissemination of the library’s data are expected to help the World Health Organization and its Regional Office prepare consensus principles on MPHOs — to be presented during the 70th World Health Assembly in 2017.

During 2015, NOTIFY Project dissemination activities included participation in Congresses of all the different types of MPHO, abstract presentations, workshops and plenary sessions in more than 15 countries. Information has been distributed through educational programs and initiatives involving hundreds of professionals, as well.

Finally, NOTIFY Library representatives have announced a new, more user-friendly format for viewing records that provides a more comprehensive structure.


Neglected Tropical Diseases Becoming Endemic in US

Public health departments and health care facilities, particularly those in warm, humid areas in the southern United States, need to devote more time and resources to prepare for tropical disease outbreaks, according to an article in “Modern Healthcare.” So-called “Neglected Tropical Diseases,” or those the Centers for Disease Control and Prevention describes as “parasitic or bacterial infections that cause substantial illness for more than one billion people globally,” are becoming more prevalent in the U.S. “We pay close attention to blood safety with respect to emerging tropical diseases,” said Susan L. Stramer, PhD, vice president for scientific affairs in Biomedical Services at the American Red Cross, chair of the AABB Transfusion Transmitted Diseases Committee and AABB past president. “Following guidelines of the U.S. Food and Drug Administration, thus far we have managed safety by ensuring that donors feel well on the day of donation and implementing investigational testing as needed. Emerging technologies such as pathogen reduction are also a critical addition to efforts to ensure the safety of our blood products moving forward.”

Last year, more than 2,700 cases of chikungunya were reported in the U.S. Both chikungunya and dengue can be found in Texas and the Gulf Coast. Increased sightings of the Aedes aegypti mosquito, the primary carrier for these viruses, indicate that the insect may be becoming endemic to these areas. In addition, cases of Chagas disease have been reported in the southern U.S. Although nearly all of these cases are believed to have been acquired elsewhere, the presence of the triatomine (or kissing) bug — which carries Trypanosoma cruzi, the parasite that causes Chagas disease — makes locally acquired infection a possibility. According to the CDC, the transmission of Chagas and dengue through blood products and organ transplants remains a threat. Recently, the first case of transfusion-transmitted Chagas disease from red blood cells, as opposed to platelets, was detected and documented in a Belgian child — of Burundian parents — with sickle cell disease. The transfusion transmission of chikungunya remains a theoretical possibility, according to the CDC.

Zika Reported in Puerto Rico; Concerns Grow Over Possible Link to Microcephaly

The first case of locally acquired Zika infection was reported in Puerto Rico in December 2015. The report prompted the Centers for Disease Control and Prevention to issue a notice warning visitors to the island to protect themselves from mosquitoes, which are known to carry the virus. The CDC issued a similar warning — aimed especially at pregnant women — travelling to Brazil and other Latin American countries based on growing fears of an association between maternal Zika infection and infants born with microcephaly, a condition characterized by an abnormally small head and developmental issues.

In October 2015, the Brazilian Ministry of Health noted an unusual increase in cases of microcephaly following the outbreak of Zika in the north-eastern states. As of Dec. 18, 2015, the European Centre for Disease Prevention and Control had reported 2,401 suspected cases of microcephaly — including 29 deaths — in Brazil. There are also concerns about a link between Zika and Guillain–Barré syndrome observed during outbreaks in French Polynesia and Brazil. Additional information is available in the agency’s Rapid Risk Assessment document.

In 2014, AABB added comments on Zika virus, the 2007 Zika outbreak in Micronesia and the 2013 Zika epidemic in French Polynesia to the emerging infectious diseases fact sheet on dengue virus.