Biovigilance Update - Winter 2014

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WINTER 2014

IN THIS ISSUE

Researchers Call for Comprehensive Approach to Transfusion Safety to Enhance Patient Care »

AABB Summarizes and Analyzes the Impact of FDA's Unique Identification System for Medical Devices »

AABB Issues Association Bulletin Updating Recommendations for TRALI Risk Mitigation for Plasma and Whole Blood for Allogeneic Transfusion »

Reminder: Hospitals Encouraged to Join AABB's PSO for Patient Safety Support »

CDC Releases Version 8.1 of National Healthcare Safety Network; Includes Updates to Hemovigilance Module »

Transfusion News Video Examines Risk Factors for Transfusion-Associated Cardiac Arrest in Pediatric Patients »

Web-Based Hemovigilance Tool for Differential Diagnosis of Transfusion Reactions Now Available »

Reminder: AABB Donor Hemovigilance Program Now Open »

AABB Submits Comments on Draft Guidance Regarding the Use of Nucleic Acid Tests to Reduce Risk of WNV Transmission From Cell and Tissue Donors »

Results of AABB Survey on Hospital Human Tissue Oversight in the U.S. Published in 'Transfusion' »

TOP NEWS

Researchers Call for Comprehensive Approach to Transfusion Safety to Enhance Patient Care

The authors of a recent "Transfusion" article are calling for health care professionals to adopt an approach to transfusion safety that involves the entire transfusion process — from the laboratory to the bedside — to help prevent patient harm, reduce errors that pose a risk to patients and increase efficiencies. In the article, "Hospital-Based Transfusion Error Tracking From 2005 to 2010: Identifying the Key Errors Threatening Patient Transfusion Safety," the investigators report on their study analyzing transfusion errors that occurred at a large teaching hospital in Canada. A total of 15,134 errors were reported into the hospital's hemovigilance reporting tool, known as the Transfusion Error Surveillance System, or TESS, with a median of 215 errors per month. Sixty percent of errors arose from the transfusion service, and 40 percent stemmed from the clinical services. According to the researchers, "errors occurred at every point in the transfusion process, with the greatest potential risk of patient harm resulting from inappropriate ordering of blood products and errors in sample labeling." The investigators emphasized the importance of active vigilance and surveillance among laboratory and clinical staff and the adherence of physicians to transfusion guidelines.

Individuals interested in learning about AABB's resources for assisting hospitals in their hemovigilance efforts should visit the AABB Center for Patient Safety Web page. AABB also offers educational materials and tools to assist in the clinical decision to transfuse blood, which are located on the association's Patient Blood Management Web page.


AABB Summarizes and Analyzes the Impact of FDA's Unique Identification System for Medical Devices

AABB posted an analysis (member-only content) of the United States Food and Drug Administration's final rule for the unique device identification, or UDI, system, which is expected to provide better tracking, inventory management and reporting of adverse events that may occur with a medical device. The analysis describes the regulations as they apply to cellular therapies, software and other medical devices involved in blood collection. The FDA is phasing in the implementation of the UDI requirements depending on the classification of the medical device.

The UDI system consists of two parts. The first component is the device identifier, or DI, the fixed portion of the overall UDI code that identifies the labeler and the specific version number or model of the medical device. The DI must be issued under a system operated by an FDA-accredited issuing agency and will be searchable in a global public database. The second component is the variable portion of the UDI known as the product identifier. The product identifier contains variable, product-specific information on the medical device such as the lot or batch number, serial number, expiration date, manufacture date and/or the cell therapy product distinct identification code. AABB's analysis of the UDI system also includes links to government and FDA resources.


RECIPIENT HEMOVIGILANCE

AABB Issues Association Bulletin Updating Recommendations for TRALI Risk Mitigation for Plasma and Whole Blood for Allogeneic Transfusion

AABB has released Association Bulletin #14-02 (member-only content), announcing that the association's Board of Directors has approved recommendations on methods to meet Standard 5.4.1.2 in the 29th edition of Standards for Blood Banks and Transfusion Services. These recommendations focus on methods for implementing measures to reduce the risk of transfusion-related acute lung injury, or TRALI, in plasma components and whole blood for allogeneic transfusion. Additionally, the bulletin outlines current scientific knowledge about the risk of TRALI from plasma transfusion and the efficacy of interventions to reduce this risk. It also describes operational and other logistical considerations for the implementation of Standard 5.4.1.2.

This standard applies to plasma collected and prepared after April 1, 2014, but not to frozen plasma collected before this date and held in inventory. The recommendations were prepared by representatives from the Blood Bank/Transfusion Service Standards Program Unit, the AABB TRALI Task Force and the work group responsible for AABB's July 2013 conference on TRALI risk reduction.


Reminder: Hospitals Encouraged to Join AABB's PSO for Patient Safety Support

Hospitals are encouraged to join AABB's patient safety organization, the AABB Center for Patient Safety, to receive support with their hemovigilance activities and to participate in targeted intervention analyses in transfusion medicine. Currently, the center is analyzing blood utilization and wastage information, providing benchmarks for participating institutions. Joining the PSO also allows hospitals to participate in the PSO teleconferences and Safe Tables — private sessions in which individuals can freely and confidentially discuss adverse events at their hospitals to learn from one another in a supportive environment. Interested institutions should contact the center at +1.301.215.6588 or by email for further information or to inform AABB of their interest in joining the PSO.


CDC Releases Version 8.1 of National Healthcare Safety Network; Includes Updates to Hemovigilance Module

The Centers for Disease Control and Prevention released version 8.1 of its National Healthcare Safety Network on Feb. 1, 2014, with updates to the Hemovigilance Module. On the Monthly Reporting Plan, facilities now indicate whether or not they are participating in surveillance for a given month. Minimal participation in surveillance requires complete reporting of all CDC-defined adverse reactions, incidents (i.e., errors or accidents) associated with adverse reactions, and denominators. On the Adverse Reaction form, delayed serologic transfusion reactions now allow for multiple antibody selections, and the transfusion date/time on the Component Details table now collects the transfusion end date/time. Whole blood products, unmodified (not irradiated or leukocyte reduced) products, discards, and the number of total crossmatch procedures have been added to the Monthly Reporting Denominators form. New process and incident codes have been added to the Incident and the Monthly Incident Summary forms. Up to 20 incident codes/incident locations and six occupation codes can be reported on a single Incident form. Lastly, minor changes were made to the order and wording of several questions on the Annual Facility Survey.


Transfusion News Video Examines Risk Factors for Transfusion-Associated Cardiac Arrest in Pediatric Patients

A recent Transfusion News video describes a study conducted by Angela C. Lee, MD, and colleagues on transfusion-associated hyperkalemic cardiac arrest, or TAHCA, in pediatric patients. Although the literature and clinical studies on this subject are not extensive, Lee and colleagues identified risk factors and ways to reduce risk to patients. Their recommendations include checking and correcting electrolyte and hemoglobin levels; avoiding rapid infusers; and employing potassium-reducing methods and large bore peripheral intravenous catheters greater than 23-gauge. Deborah Sesok-Pizzini, MD, MBA, one of the authors of an editorial on Lee's article, emphasized the importance of standardizing data collection for evaluating hyperkalemic reactions and the associated cardiac events and arrests. The video also notes the need for additional studies to better understand risk factors for TAHCA and guidelines for pediatric patients at high risk for the condition.


Web-Based Hemovigilance Tool for Differential Diagnosis of Transfusion Reactions Now Available

Transfusion Rx DDx, an open access Web application for coding transfusion reactions according to the protocol of the Hemovigilance Module of the Centers for Disease Control and Prevention's National Healthcare Safety Network, or NHSN, is now available. Created by John D. Roback, MD, PhD, associate professor of Pathology and Laboratory Medicine at the Emory University School of Medicine, and Geoffrey H. Smith, MD, a pathology resident in that program, the application asks a series of simple questions to rapidly and accurately categorize any transfusion reaction according to the NHSN criteria. Other novel features of this application include a status table showing which diagnoses have been ruled in, excluded or not yet tested; optional questions for assigning severity and imputability for each diagnosis; a written summary of which diagnoses were established (and why) as well as those that were excluded (and why); and the ability to email the written summary as a PDF document. "We think this Web application will enable any health care provider, experienced or not, to accurately and rapidly diagnose transfusion reactions according to specific NHSN Hemovigilance criteria," said Roback. Transfusion Rx DDx can be accessed at www.trddx.com via computer and smartphones.


DONOR HEMOVIGILANCE

Reminder: AABB Donor Hemovigilance Program Now Open

The AABB United States Donor Hemovigilance Program, which collects data on adverse reactions occurring in blood donors, is now open. Blood collection facilities that participate will be able to enter their data manually over the Internet and/or upload data files electronically. The data will be aggregated and analyzed so the centers can compare their experiences with national patterns. AABB, through its working group on donor hemovigilance, will produce a comprehensive review of the aggregate data, including an annual report. Only AABB and an individual center will have access to that center's data. "This program will help reduce donor reactions, which in turn will improve the donor experience," said Kevin Land, MD, FCAP, FASCP, senior medical director for Field Operations at Blood Systems Inc. and chair of AABB's Donor Hemovigilance Working Group. "Qualified donors returning to donate again helps us ensure that the blood needs of patients are met in a timely manner." Individuals interested in joining should contact AABB's Department of Research and Data Analysis at +1.301.215.6588 or by email.


WEST NILE VIRUS BIOVIGILANCE

AABB Submits Comments on Draft Guidance Regarding the Use of Nucleic Acid Tests to Reduce Risk of WNV Transmission From Cell and Tissue Donors

AABB submitted comments to the FDA on the draft guidance, "Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products," issued in October 2013. The draft guidance includes the recommendation that donors of human cells, tissues and cellular- and tissue-based products, or HCT/P, be tested for West Nile virus, or WNV, by individual donor nucleic acid testing using an FDA-licensed assay. In the comments, AABB expresses support for the general requirement for testing HCT/P donors for WNV. The association also acknowledges that the recommendation is consistent with the package inserts of the two FDA-licensed donor screening assays for WNV, which are currently approved for testing individual — but not pooled — samples from HCT/P donors. However, AABB believes that the recommendation should not be restricted to testing only individual donor samples. The association suggests a revised, more flexible recommendation that leaves room for future advances in donor screening assays such as the ability to test for WNV using pooled donor samples.


TISSUE BIOVIGILANCE

Results of AABB Survey on Hospital Human Tissue Oversight in the U.S. Published in 'Transfusion'

An AABB survey conducted in 2011 by Annette J. Schlueter, MD, PhD, and colleagues for the AABB Biovigilance Tissue Working Group measured the long-term impact of standards for tissue storage and issuance that were implemented by The Joint Commission in 2005. Recently released as part of the January 2014 issue of "Transfusion," the study followed up on a baseline AABB survey performed in 2005 to determine the level of involvement that hospital departments have in tissue handling and oversight.

The AABB Biovigilance Tissue Working Group implemented a Web-based survey that asked AABB hospital institutional members about human tissue types used, departmental responsibilities and their view of AABB involvement. Respondents reported that blood bank and transfusion services, or BBTS, and combined blood and tissue services, or CBTS, have increased responsibility since the 2005 survey for storing and monitoring eye tissue and heart valves and reporting suspected post-implantation infections. Additionally, BBTS and CBTS — more than other departments — assume stem cell and cord blood management duties. The study found BBTS is more involved with regulatory oversight than it was in 2005. Additionally, the survey revealed that member hospitals seek more guidance from AABB on implementing procedures and/or standards, clarifying the responsibilities of BBTS in tissue management and oversight, as well as advocating with tissue vendors for standardized labeling.

As a consequence of the results of this survey, the Biovigilance Tissue Working Group developed a sample informed consent form for tissue transplantation.