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Biovigilance Update - Winter 2012 

 Visit aabb.org/biovigilance

WINTER 2012

IN THIS ISSUE

2011 HHS National Blood Collection and Utilization Survey to Be Launched in February »

AABB to Hold First Patient Safety Organization Teleconference This Spring; Hospitals Encouraged to Participate »

IHN, ISBT Post International Definitions for Blood Donation and Transfusion Reactions »

Upcoming Audioconference to Highlight Causes of TRALI »

CDC Plans Release of NHSN Version 6.6.1 With Several Updates to the Hemovigilance Module »

CDC NHSN Patient Safety Component Establishes Definition for Necrotizing Enterocolitis »

Hospitals Encouraged to Join AABB's Transfusion Safety Group Within CDC's NHSN Hemovigilance Module »

Reminder: Guide Available to Help Member Hospitals Join AABB's NHSN Group »

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

Additional Blood Centers Join Donor Hemovigilance System Pilot; Individuals Encouraged to Sign Up for System Training »

HL7 Publishes Guide to Extend Hospital Data Exchange Standard to Blood Centers »

NMDP Creates Vigilance and Surveillance System for Cellular Therapies »

AABB Developing Sample Informed Consent Form for Tissue Transplantation »

AABB to Hold Additional Hemovigilance Module Recruitment Meetings in 2012 »

U.S. BIOVIGILANCE NETWORK

2011 HHS National Blood Collection and Utilization Survey to Be Launched in February

The 2011 United States Department of Health and Human Services' National Blood Collection and Utilization Survey will be mailed the week of Feb. 12. The goal of the survey is to gather reliable, accurate estimates of national and regional blood collections and information on the utilization and safety of blood, tissue and stem cell products from peripheral blood, cord blood and bone marrow origins. The HHS NBCUS also will include the collection of information on biovigilance and patient blood management activities. The survey will be mailed to all blood centers, approximately 3,000 hospitals that transfuse blood and approximately 60 cord blood banks in the U.S. AABB will accumulate, tabulate and analyze responses and prepare a comprehensive 2011 survey report, the seventh such report on collection and utilization.

"It is important to develop this accurate baseline data for a number of reasons, including biovigilance analysis and policy decisions," said Barbee Whitaker, PhD, director of AABB's Center for Data and Special Programs. "We need all facilities that receive the survey to participate." This survey has been performed by AABB biennially since 1997 and has been fully funded by HHS since 2005. Findings will support initiatives conducted by the federal government and the transfusion medicine and cellular therapy community. Participants will be able to complete the survey online or return the completed paper survey by mail. For more information, individuals should contact AABB's Center for Data and Special Programs at +1.301.215.6574 or by email.


AABB to Hold First Patient Safety Organization Teleconference This Spring; Hospitals Encouraged to Participate

AABB will hold its first teleconference for members of its patient safety organization — the Patient and Donor Safety Center, or PDSC — this spring. This patient safety organization event follows the well-attended 2011 AABB Annual Meeting "Safe Table" — the private forum where hospitals in AABB's PDSC collaborated on important hemovigilance-related patient safety issues. As with the Safe Table, the teleconference is open only to facilities that have signed a confidentiality agreement and are members of the PDSC. Hospitals that have joined receive support for their hemovigilance efforts and contribute to targeted intervention analyses in the area of transfusion medicine through participation in AABB's Transfusion Safety Group within the National Healthcare Safety Network, or NHSN. The purpose of the group is to provide recommendations for enhancements to patient safety at its member facilities. Participation also will assist with quality improvement efforts nationwide.

Those interested in joining AABB's PDSC or who have topics to recommend for upcoming teleconferences or future PDSC events should contact Barbee Whitaker, PhD, director of AABB's Patient and Donor Safety Center, at +1.301.215.6574 or by email.


IHN, ISBT Post International Definitions for Blood Donation and Transfusion Reactions

The International Haemovigilance Network and the hemovigilance working party of the International Society of Blood Transfusion, or ISBT, have now made publicly available a set of standard definitions for the surveillance of blood donor complications (published in 2008) as well as definitions for non-infectious transfusion reactions (published in 2011). The purpose of the definitions — which have been posted on the ISBT website and the new International Haemovigilance Network website — is to help harmonize hemovigilance activities around the world and to aid analyses focused on improving donor and patient safety.


Upcoming Audioconference to Highlight Causes of TRALI

AABB will host an audioconference on March 28 focusing on the causes of transfusion-related acute lung injury. Presenters Chris Silliman, MD, PhD, and Tuan Le, MD, will examine donor- and patient-related causes of TRALI and describe the role of the neutrophil priming assay for investigating the condition. Facilities can register on the AABB website. Questions may be submitted to AABB's Patient and Donor Safety Center by phone at +1.301.215.6588 or by email.


RECIPIENT SYSTEM

CDC Plans Release of NHSN Version 6.6.1 With Several Updates to the Hemovigilance Module

The Centers for Disease Control and Prevention will be implementing several enhancements to the NHSN's Hemovigilance Module, in response to user feedback. NHSN version 6.6.1, due to be released in April 2012, will include changes to the Adverse Reaction and Incident forms. The Adverse Reaction form will be rearranged so that the Component Details section follows the section on Investigation Results, and the Component Details section will allow entry of both ISBT-128 and Codabar-labeled units for a single reaction. Also, "Facility location where reaction occurred" will be changed to "Facility location where patient was transfused."

To improve the quality of adverse reaction reports, selection criteria restrictions based on the specific adverse reaction selected will be added. In the new version, only the case definition and imputability options that are listed in the CDC-defined case definitions will be available for selection for each adverse reaction. In addition, when only one unit is associated with an adverse reaction, it must be identified as the implicated unit except when reporting transfusion-associated circulatory overload. Lastly, on the Incident form, the choices for "Incident result" have been changed for clarity, while preserving the original meaning. For example, "No recovery, harm" will be restated as "Product transfused, reaction."

Individuals with questions regarding these changes or who would like to participate in the Hemovigilance Module should send an email to CDC or visit the agency's website.


CDC NHSN Patient Safety Component Establishes Definition for Necrotizing Enterocolitis

CDC's NHSN Patient Safety Component, for the entry of health care-acquired infections, has established a definition for infant necrotizing enterocolitis, or NEC, containing clinical, radiographic and surgical criteria. "This Patient Safety Component definition may be helpful for facilities participating in the NHSN Hemovigilance Module," said Barbee Whitaker, PhD, director of AABB's Patient and Donor Safety Center, adding that users of the Hemovigilance Module should report cases of NEC suspected of being associated with transfusion by using the "Other" category in the module.


Hospitals Encouraged to Join AABB's Transfusion Safety Group Within CDC's NHSN Hemovigilance Module

Hospitals are encouraged to join AABB's Transfusion Safety Group within the Hemovigilance Module of CDC's NHSN. AABB personnel, working with additional experts, will analyze the group's hemovigilance data with the intent of developing interventions that will improve patient safety — an essential mission of the U.S. Biovigilance Network. Also, through its group, AABB will review data on a confidential basis for individual hospitals and provide in-depth analyses and recommendations for enhancements to patient safety specifically at those facilities. "For hospitals already participating in the Hemovigilance Module of the NHSN, joining AABB's group involves only a few simple steps," said Barbee Whitaker, PhD, director of the AABB Patient and Donor Safety Center. The steps for joining the group are outlined on page 6 of AABB's guide, "Getting Started With Hemovigilance." Those seeking more information should contact AABB's Patient and Donor Safety Center by telephone at +1.301.215.6588 or email.


Reminder: Guide Available to Help Member Hospitals Join AABB's NHSN Group

AABB offers a step-by-step guide, "Getting Started With Hemovigilance," to help hospitals join the association's Transfusion Safety Group within the NHSN. In addition to providing instructions for joining AABB's group, the guide describes the benefits of participating in a national hemovigilance program. Enrolling in AABB's group and Patient and Donor Safety Center, a patient safety organization, gives each hospital the opportunity to participate in targeted interventions and other analyses and will help propel additional quality improvement efforts at the facility. More information on hemovigilance, including the U.S. Biovigilance Network, is available on the AABB website.


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

A mobile device tool is available for easy access to the CDC's adverse reaction definitions used in the NHSN Hemovigilance Module. The tool, which can be shared with clinicians for categorizing adverse reactions, is 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.


DONOR SYSTEM

Additional Blood Centers Join Donor Hemovigilance System Pilot; Individuals Encouraged to Sign Up for System Training

Two additional blood centers have joined the pilot of the Donor Hemovigilance System — the BloodCenter of Wisconsin and LifeShare Community Blood Services. The system, soon to be opened to all blood collection facilities, is used to track the occurrence of adverse events associated with blood donation by allowing participating facilities to enter donor reaction data and denominator data — such as the total number of donations at a facility — into a Web-based electronic data collection system. The system has sufficient flexibility to accommodate different data entry methods and allow for partial data submission. Blood collection personnel are encouraged to sign up and undergo system training. Enrollment materials, including training documents, are available on the AABB website. Individuals with questions should contact Barbee Whitaker, PhD, director of AABB's Patient and Donor Safety Center, at +1.301.215.6574 or by email.


HL7 Publishes Guide to Extend Hospital Data Exchange Standard to Blood Centers

Health Level Seven International has published a guide to extend the HL7 data exchange standard to blood centers. HL7 is a common data exchange standard used by many hospitals and clinical laboratories. The blood banking specification for the standard, which was in development for two years, allows for data exchanges between blood center devices and systems for many aspects of the blood donation experience (e.g., donor registration and product transport). Eventually, the specification may facilitate data exchanges between blood centers and hospital transfusion services.

According to a press release, the document, "HL7 Version 2.6 Implementation Guide: Blood Bank Donation Services (US Realm), Release 1," is available for purchase on HL7's website. The development team for the guide, informally called "Blood Banking HL7" or "BBHL7," was composed of standards experts, blood center IT and operations personnel, and representatives of blood establishment computer software vendors. The team received staff support from America's Blood Centers and was co-funded by the Foundation for America's Blood Centers and Blood Systems. (Note: HL7 blood donor adverse reaction codes are compliant with the Donor Hemovigilance reporting tool, Donor HART, and are available on AABB's website.)


CELLULAR THERAPY BIOVIGILANCE

NMDP Creates Vigilance and Surveillance System for Cellular Therapies

The National Marrow Donor Program has created a new vigilance and surveillance system to capture serious adverse events associated with hematopoietic stem cell transplantation as well as product quality issues. The system, highlighted in the January 2012 issue of AABB News, is a module of FormsNet, NMDP's electronic data collection system. Data on licensed and unlicensed cord blood units may be reported into the module, which was developed in conjunction with the Center for International Blood and Marrow Transplant Research. The module may be used by any U.S. hematopoietic stem cell transplant center, for units both facilitated and not facilitated by NMDP, as well as non-U.S. establishments that have received NMDP products. NMDP is currently working on modifications to allow for the reporting of adverse events and complaints associated with all cell products.

The U.S. Biovigilance Network is helping to centralize vigilance and surveillance efforts for blood, cells, tissues and organs within this country. The goal is to promote communication and harmonization among different communities, thereby promoting safety for donors and recipients of substances of human origin.


TISSUE BIOVIGILANCE

AABB Developing Sample Informed Consent Form for Tissue Transplantation

In response to concerns raised during a recent Advisory Committee on Blood Safety and Availability meeting, AABB's Biovigilance Tissue Working Group has spearheaded a project to create a sample informed consent form for tissue transplantation at hospitals in the U.S. The lack of adequate informed consent for tissue recipients at many hospitals was highlighted at the December 2011 ACBSA meeting. AABB is currently reviewing forms from a variety of sources and is working with leaders in the field to develop uniform language. AABB's goal is to promote patient safety as well as enhance tissue tracking and tissue biovigilance. Hospitals performing tissue transplantation are encouraged to participate in this process by sending their informed consent forms for the procedure to Barbee Whitaker, PhD, director of AABB's Patient and Donor Safety Center, by email. Questions also can be submitted by email or by phone at +1.301.215.6574.


ON THE ROAD

AABB to Hold Additional Hemovigilance Module Recruitment Meetings in 2012

AABB will continue its Hemovigilance Module recruitment meetings in 2012, educating hospitals about the system and its various benefits including benchmarking capabilities. Facilities interested in hosting a meeting may contact Barbee Whitaker, PhD, director of AABB's Patient and Donor Safety Center, at +1.301.215.6574 or by email.

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