Biovigilance Update - Spring 2014

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SPRING 2014

IN THIS ISSUE

AABB Releases 2012 Donor Hemovigilance Report »

AABB's 29th Edition of BBTS Includes New TRALI Mitigation Requirements; Association Holds Webinar Focused on Optimizing Use of Plasma Components »

AABB Posts Updated Infectious Disease Fact Sheets »

CDC Updates NHSN Hemovigilance Module »

CDC Encourages Facilities to Complete 2013 Hemovigilance Module Survey »

FDA Posts FY 2013 Annual Summary for Biological Product and HCT/P Deviation Reports »

Study Summarizes RBC Transfusion Complications in Thalassemia Patients »

Study Assesses TRALI Occurrence and Potential Risk Factors Among Elderly Inpatients in the U.S. »

Association Encourages Blood Collection Facilities to Report Presumed Viremic Donations to AABB's WNV Network »

International Hemovigilance Network Holds Annual Meeting; AABB Representative Speaks on Inclusion of Blood in NOTIFY Library »

AABB Adds Eye Banks to Informed Consent Form for Tissue Implants »

TOP NEWS

AABB Releases 2012 Donor Hemovigilance Report

The 2012 AABB Donor Hemovigilance Report, prepared by the AABB United States Donor Hemovigilance Working Group, is now available. This first annual report summarizes data from five blood centers — representing approximately 1.2 million donations — on adverse reactions occurring in blood donors. The overall reaction rate was 13.41 per 1,000 donation procedures. Participating blood centers used the Donor Hemovigilance and Analysis Reporting Tool, or Donor HART, software to report collection sites, donor demographics and adverse reactions. The report also describes the current capabilities and applications of the Donor HART software as well as its potential for further development. Blood centers and hospital blood banks interested in joining the AABB U.S. Donor Hemovigilance Program are encouraged to contact biovigilance@aabb.org for more information.


RECIPIENT HEMOVIGILANCE

AABB's 29th Edition of BBTS Includes New TRALI Mitigation Requirements; Association Holds Webinar on Optimizing Use of Plasma Components

The 29th edition of Standards for Blood Banks and Transfusion Services includes Standard 5.4.1.2, which requires the implementation of measures to reduce the risk of transfusion-related acute lung injury, or TRALI. The Blood Bank/Transfusion Services Standards Program Unit, or BBTS SPU, wishes to remind the users of the 29th edition that Standard 5.4.1.2 specifies that plasma and whole blood used for allogeneic transfusion must be from males; females who have never been pregnant; or females who have been tested since their most recent pregnancy and had their results shown to be negative for antibodies to human leukocyte antigens. The 29th edition became effective on April 1.

Standard 5.4.1.2 does not address apheresis platelets. The AABB TRALI Working Group continues to review the science surrounding the risk of TRALI from apheresis platelets and the efficacy of available interventions. If a standard regarding apheresis platelets is deemed appropriate, the BBTS SPU will seek public comment before finalizing the standard. For additional information and guidance on the implementation of Standard 5.4.1.2, the BBTS SPU suggests reviewing AABB Association Bulletin #14-02 and watching the recording of the association's March 27 webinar, “Suggestions for Optimizing Use of Plasma in the Era of TRALI Risk Reduction.” This complimentary webinar highlighted recent TRALI requirements that may impact the supply of plasma components. After reviewing recent trends, the speakers discussed a number of strategies available to hospitals to optimize plasma use, especially group AB plasma.


AABB Posts Updated Infectious Disease Fact Sheets

The AABB Transfusion Transmitted Diseases Committee updated the existing emerging infectious disease, or EID, fact sheets for chikungunya, dengue and hepatitis E viruses. All fact sheets are available on AABB's EID Web page.

The updated fact sheet on chikungunya virus provides information on mosquito-transmitted cases of the virus in North America. The first such cases were reported in the Caribbean in December 2013. Health authorities have recorded more than 4,200 confirmed or probable cases according to an April 28 report from the Caribbean Public Health Agency.

The fact sheet on dengue virus now includes comments on Zika virus, a mosquito-borne virus similar to dengue. This addition reflects a recent Zika virus outbreak in French Polynesia. Transfusion transmission of Zika and chikungunya viruses has not been documented at this time.

The committee updated the hepatitis E virus, or HEV, fact sheet to highlight the risk of severe complications in immunocompromised individuals, especially solid organ transplant recipients. Although there is evidence of transfusion transmission of HEV outside the U.S., there is no demonstration of significant incidence of HEV-infected donors or transfusion transmission of this virus in the U.S.

Health authorities in other countries have implemented, or are considering implementing, nucleic acid testing for chikungunya, Zika and hepatitis E viruses.


CDC Updates NHSN Hemovigilance Module

The U.S. Department of Health and Human Services Centers for Disease Control and Prevention is currently drafting the first report of adverse reaction rates from its National Healthcare Safety Network, or NHSN, Hemovigilance Module. When analyzing the data, CDC found a number of data quality issues. Module participants have been asked to review specific reporting areas to improve data quality, including denominator reporting for whole blood derived platelets and cryoprecipitate, and the linking of incident records to adverse reaction records.

Facilities now can calculate adverse reaction and incident rate tables within the Hemovigilance Module. The Adverse Reaction Rate Table provides individual rates for each adverse reaction type as well as an overall rate for all adverse reactions. The incident rate tables provide rates for incidents related to either samples or products.

CDC requests facilities to email questions and feedback to the NHSN and to include “Biovigilance” in the subject line.


CDC Encourages Facilities to Complete 2013 Hemovigilance Module Survey

The CDC recommends that facilities begin working on the 2013 Hemovigilance Module Annual Facility Survey and complete it on paper before entering the information into the National Healthcare Safety Network. The paper version of the survey is available on the CDC’s Web page. The agency is aware of issues relating to the ‘Print PDF Form’ link as well as to survey question eight. Although the data entered on survey question eight do not display correctly on the printed version of the form, the saved version and the database contain the accurate information. CDC is working to resolve these issues.


FDA Posts Annual Summary for Fiscal Year 2013 for Biological Product and HCT/P Deviation Reports

The Food and Drug Administration, on April 8, 2014, posted a summary of the biologic product deviation, or BPD, reports it received during fiscal year 2013. The summary is a compilation of the data in the BPD reports and includes comparisons and highlights of changes. FDA requires reporting of certain deviations and unexpected events in the manufacturing of blood, blood components and other licensed biological products, including human tissue and cellular and tissue-based products. As in previous years, reports involving post donation information, or PDI, made up the largest proportion of BPD reports, 71.7 percent. The second largest percentage of BPD reports, 8.3 percent, involved quality control and distribution. Travel to a malaria endemic area or a variant Creutzfeldt-Jakob disease risk area made up the largest proportion of PDI reports, 50.5 percent. Detailed information concerning deviation reporting for blood and plasma establishments as well as licensed manufacturers of biological products other than blood and blood components is available on FDA’s Biologic Product Deviations Web page.


Study Summarizes RBC Transfusion Complications in Thalassemia Patients

A March 2014 “Transfusion” article highlights the complications experienced by thalassemia patients who receive red blood cell, or RBC, transfusions. E.P. Vichinsky et al. analyzed data from approximately 400 patients who were enrolled in the CDC’s Thalassemia Blood Safety Network between 2004 and 2012. The researchers found a number of common complications including iron overload, infection and alloimmunization to minor RBC antigens. More than 75 percent of the patients experienced hemosiderosis, an excess amount of iron in the body. Approximately 25 percent of patients had been exposed to an infectious disease and 19 percent were alloimmunized. The authors recommend the establishment of national guidelines for RBC preparation and RBC phenotyping, which would match blood donors and recipients for minor as well as major blood group antigens. These measures could decrease transfusion-related complications in thalassemia patients.


Study Assesses TRALI Occurrence and Potential Risk Factors Among Elderly Inpatients in the U.S.

A study by M. Menis et al., to be published in the May 2014 issue of “Transfusion,” addresses the occurrence of and potential risk factors for transfusion-related acute lung injury, or TRALI, in U.S. hospital patients 65 years and older. The authors found a substantial increase in the incidence of TRALI when patients received platelet- and plasma-containing transfusions and when they received five or more transfusions. By examining claims data from inpatient Medicare beneficiaries who were hospitalized at least once during 2007 through 2011, the researchers found that 0.02 percent of the patients received diagnoses of TRALI. Patients who were 65 to 79 years old showed a significantly increased TRALI risk, as compared to those who were older than 79. Other risk factors included prior medical conditions, in particular post-inflammatory pulmonary fibrosis, gender and race. The authors conclude that elderly hospital patients face severe complications from TRALI including substantially longer stays and higher mortality rates, and that increased physician awareness and identification of those at-risk for TRALI may reduce such issues.


WEST NILE VIRUS BIOVIGILANCE

Association Encourages Blood Collection Facilities to Report Presumed Viremic Donations to AABB's WNV Network

Blood collection facilities are encouraged to report all presumed West Nile virus-infected, or WNV, donations to AABB's West Nile Virus Biovigilance Network. According to a CDC WNV update, the number of reported cases of WNV disease decreased by approximately 50 percent in 2013 compared with 2012 reporting. There were 685 presumed viremic donations reported to AABB's WNV Network in 2012 and 307 confirmed cases reported in 2013.

The network, launched in 2006, is designed to collect and collate 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 the FDA and the 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.


GLOBAL HEMOVIGILANCE

International Hemovigilance Network Holds Annual Meeting; AABB Representative Speaks on Inclusion of Blood in NOTIFY Library

The International Hemovigilance Network held its 16th annual seminar March 7-9 in Barcelona, Spain. The seminar covered many aspects of hemovigilance including blood donor safety, transfusion reactions and other adverse events, blood transfusion in developing countries, and optimal blood use. Barbee I. Whitaker, PhD, AABB's director of Research and Data Analysis, spoke during the plenary session about the proposed inclusion of blood in the Project NOTIFY Library — the global database of adverse events and reactions in medical products of human origin. Adding blood to the database will support education on transfusion safety for the public, clinicians and regulators worldwide. AABB members Hany Kamel, MB, BCh; Kevin Land, MD, FCAP, FASCP; and Peter Tomasulo, MD, FACP, addressed donor vigilance in their presentations, bringing international attention to donor welfare.


TISSUE BIOVIGILANCE

AABB Adds Eye Banks to Informed Consent Form for Tissue Implants

AABB's Biovigilance Tissue Working Group updated its sample informed consent form for use for U.S. hospitals conducting tissue transplantation. The form now includes eye banks, for which the Eye Banks Association of America oversees accreditation. The sample form, which includes suggested language for tissue transplantation informed consent, is posted on AABB’s website. The working group created the form to address the lack of adequate informed consent for tissue recipients, an issue highlighted by the U.S. Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability at a December 2011 meeting. Individuals with questions should contact Barbee I. Whitaker, PhD, director of AABB's Department of Research and Data Analysis, by email or phone at +1.301.215.6574.