Biovigilance Update - Summer 2014

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SUMMER 2014

IN THIS ISSUE

AABB to Alert Contacts When New Cases of WNV Are Reported »

Massachusetts Implements Hemovigilance Reporting Requirements »

FDA Releases 2013 Transfusion-Related Fatalities Report »

CDC’s National Healthcare Safety Network Begins Conversion to the Secure Access Management System »

AABB to Host Hemovigilance Pavilion at 2014 Annual Meeting; Meet With Representatives From the AABB Center for Patient Safety »

AABB Center for Patient Safety to Present Safe Tables for Pediatric and General Member Hospitals »

New Hemovigilance Track at Annual Meeting Will Include ‘Stump the Experts’ Panel Discussion »

With West Nile Virus Season Underway, Reporting WNV Presumed Viremic Donations More Critical Than Ever »

AABB Issues Association Bulletin on Babesiosis »

AABB Releases Association Bulletin on Clinical Recognition and Investigation of Suspected Bacterial Contamination of Platelets »

AABB Publishes Association Bulletin Providing Information on Potential for CHIKV Transfusion Transmission »

FDA Updates Malaria Guidance Document to Accept AABB DHQ/aDHQ Flowchart Modifications »

New DonorHART Lite Tool Helps Facilities Participate in Donor Hemovigilance »

U.K. National Health Service Releases 2013 Serious Hazards of Transfusion Report »

TOP NEWS

AABB to Alert Contacts When New Cases of WNV Are Reported

AABB will begin sending email alerts this week to individuals on the West Nile Virus, or WNV, laboratory contacts list to notify them when a blood center has reported a new presumed viremic donation, or PVD, to the AABB WNV Biovigilance Network. The automated alerts, which are triggered when an entry is made to the network, will provide the donation’s collection date and location, the signal/cutoff value, if applicable, and the final test interpretation when one is present. Individuals may sign up to receive the alerts by sending an email to Hemovigilance@aabb.org.


Massachusetts Implements Hemovigilance Reporting Requirements

In June 2014, Massachusetts became the first state requiring its hospitals to participate in the Centers for Disease Control and Prevention’s National Healthcare Safety Network, or NHSN, Hemovigilance Module. As of August 11, 100 percent of the 70 blood banks and transfusion services in the state had activated the Biovigilance Component containing the module, and 94 percent had begun reporting data through NHSN to the Massachusetts Department of Public Health, or MDPH. The remaining blood banks were reportedly progressing toward fulfilling their requirements. A number of Massachusetts blood banks and transfusion services have joined the AABB Center for Patient Safety group and have begun participating in national level benchmarking with peer hospitals in other states.

According to Melissa Cumming, MS, Hemovigilance and Zoonotic Project Coordinator at MDPH, the smoothest aspects of the rollout were the facility activation of the Biovigilance Component and the granting of user and administrative rights to blood bank staff. “Because all acute care facilities in Massachusetts already use NHSN and MDPH had an existing relationship with NHSN facility administrators, it was relatively straightforward to contact this group all at once with a request to activate the component and designate their primary hemovigilance users,” said Cumming. “This was reflected in the high rate of component activation early on in the process. The designation of primary hemovigilance user(s) also triggered the process for obtaining secure access to NHSN (either through a digital certificate or SAMS [the government’s system for award management]) and it proved beneficial to have facility administrators get the ball rolling quickly for their blood banks. Another positive aspect of the roll out has been the responsive support from CDC to both MDPH and the blood banks. This support has been instrumental in dealing with occasional enrollment issues and technical questions when they arose.”

Cumming noted that an important lesson learned so far focuses on location coding. In the Hemovigilance Module, adverse events and incidents are assigned to the particular location within the facility where they occurred. Location “codes” within a facility are shared between all components in NHSN, including Patient Safety and Biovigilance. If a Hemovigilance Module user attempts to modify an existing location or inadvertently adds a duplicate to an existing one, this can impact reporting of Patient Safety Data for the Centers for Medicare and Medicaid Services. For this reason, Hemovigilance Module users are urged to contact their facility administrator before adding or modifying any location codes. “This recommendation has been well-received by facility administrators,” said Cumming.


FDA Releases 2013 Transfusion-Related Fatalities Report

The Food and Drug Administration has released an annual summary of fatalities following blood collection and transfusion for fiscal year 2013 — Oct. 1, 2012, through Sept. 30, 2013. During the period covered by the FY 2013 summary, the FDA received 72 fatality reports — 65 were transfusion-recipient fatalities and seven were post-donation fatalities. Of the 65 transfusion-recipient fatalities, 38 were determined to be transfusion-related, while 21 were cases in which transfusion could not be ruled out as the cause of the fatality and reporting facilities were unable to identify a specific complication of transfusion as the cause of death. The remaining fatalities were found to be unrelated to transfusion.

As in the previous five years, transfusion-related acute lung injury, or TRALI, caused the highest number of reported fatalities, followed by transfusion associated circulatory overload, hemolytic transfusion reactions, microbial infections and anaphylactic reactions. Given the large number of blood components transfused each year, the report notes that the number of fatalities remains small in comparison.

Hospitals are encouraged to report transfusion reactions through the Hemovigilance Module of the NHSN and join AABB’s group within the module to receive analyses of their data. Fatal reactions must also be reported to the FDA, and instructions on how to do so are located on the FDA’s website. Data from the FDA transfusion-related fatality report show that transfusion remains extremely safe.


CDC’s National Healthcare Safety Network Begins Conversion to the Secure Access Management System

The CDC’s NHSN has begun inviting its users to access the network through the Secure Access Management System, or SAMS. The new system, which replaces the Secure Data Network, will not require the use of digital certificates. Instead, NHSN users will be able to access the application from any computer with a password and a SAMS grid card. As of early June, nearly 30 percent of all NHSN users had started migrating to SAMS. For more information, visit the SAMS information page or contact NHSN.


HEMOVIGILANCE AT ANNUAL MEETING

AABB to Host Hemovigilance Pavilion at 2014 Annual Meeting; Meet With Representatives From the AABB Center for Patient Safety

AABB will host a Hemovigilance Pavilion at its 2014 Annual Meeting, to be held October 25-28 in Philadelphia. A variety of educational materials on patient and donor safety will be on display at the pavilion, which will be located near the bookstore. AABB staff and other subject matter experts will be available to discuss important issues as well as to conduct tailored demonstrations of the NHSN’s Hemovigilance Module and the Web-based Donor HART software.

AABB Annual Meeting attendees will have the opportunity to engage with representatives from the AABB Center for Patient Safety, or AABB CPS, the association’s patient safety organization. Focused on hemovigilance, the AABB CPS is dedicated to confidentially collecting and analyzing data on adverse reactions and incidents associated with blood transfusion. Through analyses, the AABB CPS strives to identify and communicate best practices and to design interventions to improve patient safety. The AABB CPS will host an invitation-only information session on October 27, at which time hemovigilance experts and current members of the AABB CPS will describe the benefits and “how to” steps of participating in the association’s hemovigilance program. Registration for the 2014 AABB Annual Meeting is available through the association’s website. Individuals interested in attending the information session should contact the AABB CPS at +1.301.215.6588 or by email at hemovigilance@aabb.org to request an invitation.

AABB has just introduced an Annual Meeting mobile app for those who use smart devices. The free interactive tool can be downloaded from the AABB website.


AABB Center for Patient Safety to Present Safe Tables for Pediatric and General Member Hospitals

Individuals from hospitals that are members of the AABB CPS are eligible to participate in the fourth Annual Meeting Safe Table — to be held on Friday, October 24. This year, AABB will host a general safe table session and one specifically for pediatric hospitals. During this private event, center members can discuss adverse events in their hospitals and learn from their peers in a confidential environment. The agenda also will include expert-led discussions of anonymized transfusion reaction case studies.


New Hemovigilance Track at Annual Meeting Will Include ‘Stump the Experts’ Panel Discussion

AABB will highlight hemovigilance at its 2014 Annual Meeting through a series of focused sessions — marked with the designator “HEM” on the agenda. At the “Stump the Hemovigilance Experts" session — to be held October 26 from 10:30 until noon — expert panelists will discuss the coding and categorization of adverse reactions according to national definitions. Participants are encouraged to bring or submit challenging cases from their own experience. Additional sessions will cover such topics as the use of hospital hemovigilance data to improve performance and tissue hemovigilance considerations for blood bankers.


TRANSFUSION TRANSMITTED INFECTIONS

With West Nile Virus Season Underway, Reporting WNV Presumed Viremic Donations More Critical Than Ever

Sixty-eight donations that were confirmed positive for West Nile virus, or WNV, have been reported to AABB’s WNV Biovigilance Network as of Aug. 19, 2014, in addition to 67 presumed viremic donations that are still awaiting test interpretation. The association encourages blood collection facilities to report all presumed WNV-infected donations to AABB’s WNV Biovigilance Network. The network, created by the AABB WNV Task Force and launched in 2006, is designed to collect and report data on donors with suspected WNV infection in the U.S. and Canada.

This 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 amplification testing (NAAT) for WNV. The map and charts are updated in real time as data is entered into the system.

At the time of their initial report to the AABB website, facilities should enter the donor’s residential zip code to ensure that the presumed viremic donation is included on the map. Facilities are reminded, as well, to update the site with confirmatory information as it becomes available. AABB requests that facilities review and update their contact information so they can be notified if individual donor NAAT is triggered in their area.


AABB Issues Association Bulletin on Babesiosis

The AABB Board of Directors released Association Bulletin #14-05 to provide updated information and recommendations regarding the epidemiology, clinical manifestations, diagnosis and treatment of babesiosis — including transfusion-transmitted babesiosis, or TTB — as well as the management of potential TTB and measures to mitigate TTB risk. Developed by the AABB Transfusion Transmitted Diseases Committee's Babesia and Other Tick-Borne Diseases Work Group, the bulletin also identified critical issues requiring further consideration. This bulletin supersedes Association Bulletin #09-06.


AABB Releases Association Bulletin on Clinical Recognition and Investigation of Suspected Bacterial Contamination of Platelets

The AABB Board of Directors has published Association Bulletin #14-04 to provide transfusion service medical directors with guidance on the recognition of suspected reactions to bacterially contaminated platelets and the steps recommended to minimize patient harm. AABB encourages directors to share this document with their hospital transfusion committee members for dissemination to clinical staff and incorporation of the recommendations into the institution's policies. The bulletin contains clinical criteria to assist in the investigation of suspected reactions to bacterially contaminated platelets and bedside actions to help support the patient. In addition, the bulletin lists steps that transfusion service and blood center staff can take to help protect other patients from receiving contaminated co-components. The AABB Transfusion Transmitted Diseases Bacterial Contamination Work Group developed this bulletin as a supplement to Association Bulletin #12-04, which included a recommendation to focus on improved recognition and monitoring of suspected transfusion reactions in all platelet components.


AABB Publishes Association Bulletin Providing Information on Potential for CHIKV Transfusion Transmission

The AABB Board of Directors has released Association Bulletin #14-03 in response to the ongoing outbreak of chikungunya virus, or CHIKV, infection in the Caribbean islands. The AABB Transfusion Transmitted Diseases, or TTD, Committee developed this bulletin to provide information about the potential for transfusion-transmitted CHIKV. The bulletin includes educational postdonation information, or PDI, materials for use by blood collection organizations and considerations for the collecting facility in response to PDI reports.

CHIKV has received increasing attention in North America due to the high volume of travel to and from the Caribbean islands and the identification of autochthonous vectorial transmission in the Caribbean islands during December 2013. The high volume of travel between North America and the Caribbean islands has led to confirmed cases of the virus in North America. Although transfusion transmission of CHIKV has not been documented, it is theoretically possible as the virus is present in blood for several days and because about 20 percent of cases are asymptomatic.

The AABB TTD Committee is monitoring the situation, and AABB will release additional information when it becomes available.


FDA Updates Malaria Guidance Document to Accept AABB DHQ/aDHQ Flowchart Modifications

On August 1, the FDA published an updated guidance, “Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria,” for immediate implementation. The guidance recognizes the revised AABB flowcharts as acceptable for screening donors of blood and blood components for malaria risk. As established in the 2013 malaria guidance document, the FDA asks that blood establishments implement the recommendations from the revised guidance no later than Aug. 19, 2014.

The updated malaria guidance document both recognizes the updated flowcharts and provides an implementation strategy for the acceptable documents. Facilities who begin utilizing the revised flowcharts, and those using them with minor formatting changes, may report these changes in the facility’s annual report. Specific flowchart modifications to both the DHQ and the abbreviated DHQ are described on the AABB website. Questions should be directed to regulatory@aabb.org.


DONOR HEMOVIGILANCE

New DonorHART Lite Tool Helps Facilities Participate in Donor Hemovigilance

Knowledge Based Systems Inc. recently released DonorHART Lite, a modified form of the Donor Hemovigilance and Analysis Reporting Tool, or DonorHART, software that allows users to report, analyze and view donor hemovigilance data. DonorHART Lite, developed with funding from the U.S. Department of Health and Human Services and the U.S. Department of Defense, is now available in addition to the fully functional DonorHART software. Donor HART Lite allows blood collection facilities to enter information into a critical subset of the fields available in Donor HART and to generate reports. The AABB Donor Hemovigilance Working Group designed DonorHART Lite for blood centers and hospitals that currently do not gather all of the comprehensive data supported by the full DonorHART software, but want to participate in donor hemovigilance. Blood collection facilities can migrate to the full version of the software once they are able to collect and submit additional data elements. The working group deliberately designed the DonorHART Lite software to support future donor hemovigilance analysis requirements and provide facilities with a roadmap to expand their data collection over time.


GLOBAL BIOVIGILANCE

U.K. National Health Service Releases 2013 Serious Hazards of Transfusion Report

The 2013 Serious Hazards of Transfusion, or SHOT, Report, released on July 9 in the United Kingdom, indicates that preventable human error still causes the majority of all transfusion related adverse events — 77.6 percent of reports. Human factors were responsible for nine ABO incompatible red cell transfusions in 2013, although cumulative SHOT data show that two-thirds of those transfusions did not result in any harm. The report recommends a final checklist be used at the patient’s bedside, which could potentially catch and remedy mistakes, while noting that a checklist alone cannot eliminate human error. Finally, the writers recommend additional training in teamwork for those involved in the transfusion process as a means to provide a better understanding of why certain types of error continue to occur. The report, a report summary and related material can be viewed online at the SHOT website.