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Biovigilance Update - Winter 2011 

A Message From AABB CEO Karen Shoos Lipton

February marks the one-year anniversary of the National Healthcare Safety Network's Hemovigilance Module — our national system for tracking adverse events in transfusion medicine. Developed by CDC with input from AABB through the association's Interorganizational Task Force on Biovigilance, the Hemovigilance Module is a milestone of great importance for patient safety in the U.S. and one that has become a top priority for AABB. Because of the significance of this initiative, we wanted to begin sharing news about biovigilance with all of our members through this newsletter.

We are proud of the progress we have made and are looking forward to continuing our partnership with CDC and other key stakeholders in biovigilance. The Hemovigilance Module and the Donor Hemovigilance System, which was launched in the last quarter, will undoubtedly play a major role in improving the health and safety of transfusion recipients and blood donors in the years to come. With these two systems under way, we now look forward to the expansion of the U.S. Biovigilance Network to cover organs, tissues and cellular therapies.

I encourage hospitals that have not yet joined the Hemovigilance Module to take the steps to join today. The module is well-protected, and the effort will benefit not only patient safety in the broad context, but each individual facility as well.

For more information on the U.S. Biovigilance Network and how to participate in the Hemovigilance Module or Donor Hemovigilance System, please contact us with your inquiries.

Sincerely,

Karen Shoos Lipton, JD
Chief Executive Officer

 Visit aabb.org/biovigilance

WINTER 2011

IN THIS ISSUE

Nearly 100 Hospitals Enrolled in NHSN Hemovigilance Module at
1-Year Anniversary; Data Submissions Steadily Increasing »

AABB Creates Guide to Help Member Hospitals Join AABB's NHSN Group »

AABB News Article Highlights Association's NHSN Group/PSO Activities and Biovigilance-Accreditation Firewall »

CDC Partners With CMS HAI Program, Increases NHSN Server Capacity »

CDC Making Way for Electronic Data Entry in Hemovigilance
Module »

AABB Task Force to Issue Tissue Survey in March »

Mobile Device Tool Created for Easy Access to Hemovigilance Adverse Reaction Definitions »

Materials Available to Facilitate Participation in NHSN Hemovigilance Module »

Presentation at International Haemovigilance Seminar Describes System Features, Blood Center Implementation »

Journal of Pediatrics Study Finds Link Between Packed Red Blood Cell Transfusion and Necrotizing Enterocolitis »

Journal Article Highlights Benefits of Transfusion Error-Reporting System »

AABB Continues Hemovigilance Educational Activities in U.S., Abroad »

U.S. BIOVIGILANCE NETWORK

Nearly 100 Hospitals Enrolled in NHSN Hemovigilance Module at 1-Year Anniversary; Data Submissions Steadily Increasing

Since the launch a year ago of the Hemovigilance Module of the Centers for Disease Control and Prevention's National Healthcare Safety Network, nearly 100 hospitals have enrolled, and more continue to join. CDC estimates that more than 2,500 adverse reactions and incidents have been entered thus far. CDC plans to analyze and publish the aggregate data and to develop evidence-based public health recommendations for the transfusion community. Hospitals interested in joining the Hemovigilance Module should visit the CDC website for more information.


AABB Creates Guide to Help Member Hospitals Join AABB's NHSN Group

AABB has created a guide to provide additional assistance to hospitals seeking to join AABB's group within CDC's NHSN Hemovigilance Module. In addition to describing the benefits of hemovigilance and joining the module, "Getting Started With Hemovigilance" includes steps hospitals can take to join AABB's Transfusion Safety Group. Although not a requirement, enrolling in AABB's group and patient safety organization will give each hospital an opportunity to participate in targeted intervention analyses to help further propel quality improvement efforts at the facility and nationwide. Those interested in joining AABB's group and PSO should visit the association's website or contact Barbee I. Whitaker, PhD, director of data and special programs at AABB, by phone at 301-215-6574 or by e-mail.


AABB News Article Highlights Association's NHSN Group/PSO Activities and Biovigilance-Accreditation Firewall

The January issue of AABB News features an article on the protection of hemovigilance data in the association's NHSN group and patient safety organization as well as the firewall between AABB's biovigilance and accreditation programs. "Data Sharing and Confidentiality in Recipient Hemovigilance Adverse Event Reporting" describes how data are protected under the Public Health Service Act and Patient Safety Act. It defines the steps facilities can take to protect patient-specific hemovigilance data and explains how to receive confidential reports and analyses from AABB. The firewall that separates AABB's biovigilance and accreditation activities ensures that data collected for the purposes of improving patient safety are reported without being shared with AABB's assessors or accreditation functions. All biovigilance-related data are fully protected and secured under AABB's patient safety organization, also known as AABB's Patient and Donor Safety Center.


CDC Partners With CMS HAI Program, Increases NHSN Server Capacity

CDC has entered into a partnership with the Centers for Medicare and Medicaid Services to make data on health care-associated infections, or HAIs, more transparent and to improve accountability within the U.S. health care system. According to the agency, the NHSN will be the tool used by facilities electing to participate in the CMS HAI Inpatient Prospective Payment System Hospital Inpatient Quality Reporting Program. As part of this program, central line-associated bloodstream infection data from each facility's adult, pediatric and neonatal intensive care units will be reported to the NHSN and shared with CMS. There are more than 4,000 facilities currently using the NHSN as part of their HAI elimination initiatives. To accommodate the increase in data to be submitted to the NHSN, CDC has doubled the number of NHSN servers, increasing computer memory and capacity.


CDC Making Way for Electronic Data Entry in Hemovigilance Module

CDC has completed and issued the full implementation guidance for the electronic entry of data into the Hemovigilance Module. The guidance describes NHSN's clinical document architecture, which software developers can use to develop tools to submit data electronically to the Hemovigilance Module, decreasing hospitals' data-entry burden. CDC is planning to have the NHSN CDA application configured in October and is planning to begin a pilot in that time frame. For more information, individuals should contact CDC's contracted project manager, Marla Albitz.


AABB Task Force to Issue Tissue Survey in March

AABB's Tissue Task Force will release a Web-based survey to AABB member hospitals in March seeking information on tissue activities at the facilities. Specifically, the task force is looking for information on the types of tissues used, breadth of the hospital's responsibilities concerning them (such as tracking and adverse event investigations), the roles of different departments, and views on AABB's involvement. The survey is being conducted as part of AABB's commitment to biovigilance and to patient safety. The results of a previous study were published in the February 2007 issue of Transfusion.


RECIPIENT SYSTEM

Mobile Device Tool Created for Easy Access to Hemovigilance Adverse Reaction Definitions

A mobile device tool has been created for easy access to the CDC's adverse reaction definitions used in the NHSN Hemovigilance Module. The tool has been designed to work on iPhones, iPads, and other mobile Internet-access devices. Those interested in using the tool should bookmark the URL of the Web page where it is located. Additional information on hemovigilance, including the U.S. Biovigilance Network, is available on the AABB website.


Materials Available to Facilitate Participation in NHSN Hemovigilance Module

Various educational materials, including instructions, are available on the CDC website to facilitate hospital participation in the agency's NHSN Hemovigilance Module. In particular, there are six printable forms that can be used to aid data entry into the system. All of the forms can be used prior to official enrollment in the module to allow individuals to become familiar with the necessary data collection steps and to have data readily available for entry upon enrollment.


DONOR SYSTEM

Presentation at International Haemovigilance Seminar Describes System Features, Blood Center Implementation

Features of the Donor Hemovigilance System and its current status were presented by Mary Townsend, MD, of Coffee Memorial Blood Center at the 13th International Haemovigilance Seminar, held Feb. 9-11 in Amsterdam. During the meeting Townsend also discussed the successful implementation of the system at her facility. She described the Web-based Donor Hemovigilance Analysis and Reporting Tool, or Donor HART, and how the public-private partnership between the government and blood banking community — including AABB, the American Red Cross, America's Blood Centers, the Armed Services Blood Program and others — led to the creation of this hemovigilance system. These organizations adopted harmonized definitions, allowing the data to be comparable across a variety of classification schemes. The system has sufficient flexibility to accommodate different data-entry methods and to allow for partial data submission. Users have the ability to generate standard and custom reports for quick analysis of key reaction rates. Townsend reported that her center has collected 18 months of data on donor reactions by using the system and has successfully implemented an intervention based on the findings. Further information on Donor HART and joining the Donor Hemovigilance System is available by contacting AABB's Center for Data and Special Programs by e-mail or by phone at 301-215-6588.


IN THE NEWS

Journal of Pediatrics Study Finds Link Between Packed Red Blood Cell Transfusion and Necrotizing Enterocolitis

A study in an upcoming issue of the Journal of Pediatrics concluded that there is an association between packed red blood cell transfusion and necrotizing enterocolitis, or NEC, in very low birth weight neonates. The researchers reviewed the records of very low birth weight patients admitted to the neonatal intensive care unit during an 18-month period. They propose the acronym TRAGI — for transfusion-related acute gut injury — to characterize the severe gastrointestinal reaction in the premature neonates after an infusion of packed red blood cells. The study and an upcoming editorial in the journal also note other reports of a relationship between red blood cell transfusion and the development of NEC in very low birth weight neonates with moderate anemia and the need for additional studies concerning this issue. The study and the editorial are currently in press and are available only online. The authors of the study have established an online registry for TRAGI cases with the intention of collecting information from a diverse group of institutions with different clinical practices, identifying clinical correlates of TRAGI and identifying groups interested in a clinical trial. In addition, facilities participating in the NHSN Hemovigilance Module are encouraged to report cases of NEC suspected of being associated with transfusion by using the "Other" category. This category should be used for all adverse reactions possibly linked to transfusion that cannot be classified under another category.


Journal Article Highlights Benefits of Transfusion Error-Reporting System

The latest issue of the Journal of Blood Services Management, mailed with the December issue of the journal Transfusion, includes an article discussing the benefits of using an error-reporting system in a hospital's transfusion medicine unit. According to the authors, the system implemented was based on the Medical Event Reporting System – Transfusion Medicine, or MERS-TM, which also is the basis for incident reporting in CDC's Hemovigilance Module. The system was used to collect data on all near-misses, no-harm events and "misadventures" related to the transfusion process. A root cause analysis of a "mistransfusion but no-harm" event showed how an error-reporting system such as the one implemented can reveal practices that need to be changed to improve transfusion safety. Several factors were identified as root causes of the error, including human, organizational and patient-related factors, and practices were changed to prevent future occurrences. The authors concluded that their study illustrates the usefulness of having an error-reporting system in hospitals to help identify human and system failures associated with transfusion that may otherwise go unrecognized.


ON THE ROAD

AABB Continues Hemovigilance Educational Activities in U.S., Abroad

AABB continued to educate individuals and institutions about the value of hemovigilance during the past quarter, and a number of additional activities are planned for the coming months.

AABB CEO Karen Shoos Lipton, JD, gave a presentation in January on the U.S. Biovigilance Network to an audience that included transfusion safety officers at the Indiana Blood Center. At the 13th annual International Haemovigilance Seminar in the Netherlands in February, Barbee I. Whitaker, PhD, director of data and special programs at AABB, gave a presentation on public-private hemovigilance activities with Jerry Holmberg, PhD, senior adviser for blood policy at the U.S. Department of Health and Human Services. D. Michael Strong, PhD, MT(ASCP), who served as chair of the AABB Interorganizational Biovigilance Network Steering Committee, presented an update on international biovigilance. Also at this meeting, Mary Townsend, MD, of Coffee Memorial Blood Center, described features of the Donor Hemovigilance System, its current status and the successful implementation of the system at her facility (see the article under "Donor System" above).

In the spring, CDC representatives and Barbee Whitaker will give presentations at the joint meeting of the California Blood Bank Society and South Central Association of Blood Banks in Las Vegas, which will be held in April. AABB also will have a booth at this event. At the American Association of Critical-Care Nurses Conference in May in Chicago, AABB will have an educational stage where individuals can receive continuing medical education credits. Those interested in additional information on AABB's hemovigilance educational initiatives should contact AABB's Center for Data and Special Programs by e-mail or by phone at 301-215-6588.

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