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Biovigilance Update - Summer 2013 

 Visit aabb.org/biovigilance

SUMMER 2013

IN THIS ISSUE

The AABB Center for Patient Safety to Be a Key Feature of AABB Annual Meeting & CTTXPO »

Biovigilance-Related Topics to Be Featured in AABB Annual Meeting Educational Program »

AABB Announces New TRALI Risk Reduction Standards »

HHS Publishes 2011 National Blood Collection and Utilization Survey Report; Facilities Encouraged to Prepare for 2013 Data Submission »

2012 SHOT Report: More Than 60 Percent of Adverse Events Due to Preventable Errors »

CDC Begins Upgrade of NHSN Security System; New Versions of NHSN, Hemovigilance Protocol Available in August »

CDC to Hold NHSN Hemovigilance Module Webinar; Releases New Training Materials »

Recording Available for AABB's Audioconference on Deciphering Imputability for Hemovigilance Reporting »

JAMA: West Nile Virus Now Endemic Throughout Contiguous United States »

AABB Issues Association Bulletin; Updates Recommendations for WNV Testing »

HHS Releases Guideline for Organ Donor Screening »

'Transfusion' Study Suggests Blood Donation Does Not Lower Risk of CHD »

Transfusion News Video Highlights Transfusion-Transmitted Hepatitis B From Donors With Occult Infection »

Recent Issue of 'AABB News' Explores Use of Patient-Centric Data Metrics to Improve Care »

TOP NEWS

The AABB Center for Patient Safety to Be a Key Feature of AABB Annual Meeting & CTTXPO

The AABB Center for Patient Safety, or AABB CPS, will be a key feature of the association's 2013 Annual Meeting & CTTXPO, being held Oct. 12-15 in Denver. The AABB CPS — a patient safety organization — focuses on recipient and donor hemovigilance by collecting and analyzing data on adverse reactions and incidents related to blood transfusions and donations. Hospitals are encouraged to join the AABB CPS to receive support with their hemovigilance efforts and to participate in targeted intervention analyses in transfusion medicine. Blood centers that join the U.S. Donor Hemovigilance Program can take part in a multitude of activities and analyses aimed at ensuring donor health and safety.

Individuals are encouraged to visit the AABB Biovigilance Pavilion during the Annual Meeting. A variety of educational materials on patient and donor safety will be available at this site, which will be located near the registration area. AABB staff and other subject matter experts will be available to discuss important issues as well as to conduct personalized demonstrations of the Hemovigilance Module of the Centers for Disease Control and Prevention's National Healthcare Safety Network and the Web-based Donor Hemovigilance Analysis and Reporting Tool, or Donor HART, software.

Additionally, the AABB CPS will be conducting its third Annual Meeting Biovigilance Safe Table — a private session in which members of the center can freely and confidentially discuss adverse events at their hospitals with their peers to learn from one another in a supportive environment. The agenda for this event — to be held Monday, Oct. 14, from noon to 2 pm — will include a discussion of case studies of transfusion reactions.

Registration for the 2013 AABB Annual Meeting & CTTXPO is open. Individuals can register on the AABB website. Those who want to become a member of the AABB CPS or who have questions regarding its activities may contact the center at +1.301.215.6588 or by email.


Biovigilance-Related Topics to Be Featured in AABB Annual Meeting Educational Program

AABB has added several biovigilance-related sessions to its Annual Meeting educational program. The AABB Center for Patient Safety will hold an invitation-only information and discussion session where interested participants can have biovigilance questions answered and network with other professionals committed to biovigilance and patient safety. This information session will include a brief introduction to AABB's biovigilance and patient safety offerings followed by roundtable discussions with current patient safety organization members, hemovigilance experts, and patient safety organization staff. Individuals interested in attending this event should contact the AABB Center for Patient Safety at +1.301.215.6588 or by email to request an invitation.

AABB also will hold an "Ask the Biovigilance Experts" session in which a panel of experts representing a variety of public and private perspectives will discuss the current landscape in biovigilance. Questions for the discussion may be submitted during the session — to be held Monday, Oct. 14, from 10:30 am to noon — as well as prior to the event through the AABB website and at kiosks in the Cyber Connection site located in the Colorado Convention Center.

Additional sessions cover such topics as using hemovigilance data, donor vigilance, the role of nurses in transfusion safety, understanding allergic transfusion reactions, error management, and the impact of non-ABO-related hemolytic transfusion reactions. A "Biovigilance Schedule-at-a-Glance" listing all biovigilance-related events will be available at the AABB Biovigilance Pavilion. Individuals interested in attending these educational sessions can register for the Annual Meeting & CTTXPO on the AABB website.


AABB Announces New TRALI Risk Reduction Standards

The AABB Blood Bank/Transfusion Service Standards Program Unit, or BB/TS SPU, has announced new risk reduction standards for transfusion-related acute lung injury, or TRALI. These standards are part of the 29th edition of Standards for Blood Banks and Transfusion Services, which will go into effect April 1, 2014. The new requirements expand existing criteria for evaluation of donors implicated in a TRALI event or associated with multiple events of TRALI. The standards, once effective, require that high-plasma volume components for allogeneic transfusion come from males, females who have not been pregnant, or females who have been tested since their most recent pregnancy and determined to be negative for human leukocyte antigen antibodies. These requirements become effective April 1, 2014, the same day as the rest of the 29th edition. However, the implementation date for apheresis platelet products will be delayed until Oct. 1, 2014, to minimize any impact on availability. Members of the AABB BB/TS SPU, TRALI Task Force and Board of Directors are developing an association bulletin with specific guidance on ways to meet the new standards. Questions can be submitted to standards@aabb.org.


HHS Publishes 2011 National Blood Collection and Utilization Survey Report; Facilities Encouraged to Prepare for 2013 Data Submission

The U.S. Department of Health and Human Services, or HHS, has released the 2011 National Blood Collection and Utilization Survey report, which provides 2011 data on the collection and transfusion of blood, identifies trends and compares current findings with those of previous survey years. According to the report, the supply of available allogeneic whole blood, or WB, and red blood cell, or RBC, units, after accounting for test discards, was nearly 14.5 million units in 2011, which is a statistically significant decrease of 9.1 percent compared with the supply of allogeneic WB and RBCs in 2008. The 2011 report explains that, over the past several years, blood collectors have made adjustments to correct the oversupply of WB and RBCs that was identified in the 2009 survey report. Additionally, transfusions of WB and RBCs declined significantly by 8.2 percent to 13.8 million units. The blood supply was provided by more than 9 million allogeneic donors — 31 percent of whom were first-time donors and 69 percent of whom had donated previously. A total of 20.9 million components were transfused, including WB, RBCs, platelets, plasma, cryoprecipitate and granulocytes, representing a decrease of 11.6 percent compared with transfusions in 2008.

Thirty percent of 2011 hospital respondents reported having some form of patient blood management program in their establishments. The recent survey was the first time facilities were asked about patient blood management activities. The results will establish a baseline for subsequent surveys.

The 2011 HHS report, produced by AABB, is available as a free download on the AABB and HHS websites. Hospitals, blood centers, and cell therapy facilities are encouraged to prepare for the 2013 data submission by reviewing the questions from the 2011 survey. Individuals with questions should contact the AABB Center for Data and Special Programs at +1.301.215.6588 or by email.


GLOBAL BIOVIGILANCE

2012 SHOT Report: More Than 60 Percent of Adverse Events Due to Preventable Errors

Nearly 62 percent of all adverse events reported to the United Kingdom's hemovigilance system — Serious Hazards of Transfusion, or SHOT — were attributable to preventable human error in 2012, noted SHOT researchers in their recent report. The authors said that this excludes "near-miss" and "right blood, right patient" reports concerning no patient harm. However, if these reports were included, the percentage of preventable errors would rise to 77.6. The percentage of adverse events attributable to preventable human error last year was 53.4. The leading cause of pathological (and unpredictable) events was acute transfusion reactions.


RECIPIENT HEMOVIGILANCE

CDC Begins Upgrade of NHSN Security System; New Versions of NHSN, Hemovigilance Protocol Available in August

The Centers for Disease Control and Prevention has begun to transition the National Healthcare Safety Network, or NHSN, from the Secure Data Network to Secure Access Management Services, or SAMS, for user identity verification. This change will eliminate the need for "digital certificates" to access the NHSN. According the agency, SAMS will not require the user to install anything on his or her computer and will not require an annual renewal. CDC plans to gradually migrate users to SAMS and anticipates that full migration of all 22,000 NHSN users will take approximately two years to complete. To help simplify the process, CDC encourages facilities to periodically check the users of the system and deactivate the profiles of any users who no longer need access. As with digital certificates, SAMS accounts or profiles cannot be shared.

CDC released NHSN version 7.2 Aug. 24 and soon also will issue an updated version of the Hemovigilance Module surveillance protocol (version 2.1). Missing Data alerts for incident reporting will be temporarily deactivated in the NHSN as they no longer coincide with reporting requirements; they will be active again in January 2014. Minor updates to the Hemovigilance Module Adverse Reaction Case Definition Business Rules will be implemented to mirror recent changes to the Hemovigilance Module surveillance protocol.


CDC to Hold NHSN Hemovigilance Module Webinar; Releases New Training Materials

The CDC will hold a webinar Aug. 29 on the NHSN Hemovigilance Module. The webinar will focus on reporting zero adverse reactions or incidents during a month using the Monthly Reporting Denominators form. It also will focus on completing the Monthly Reporting Denominators form, resolving alerts on the Incomplete/Missing List, and changes to the surveillance protocol (revised adverse reaction case classification criteria). In addition, there will be a question-and-answer period. Those interested in registering for the event should visit the NHSN website.

The agency also has released two new quick reference guides on its NHSN Biovigilance Component Web page: "Reporting Zero Adverse Events" and "Joining a Group." Individuals with questions should send an email to the CDC with the subject line, "Biovigilance Component."


Recording Available for AABB's Audioconference on Deciphering Imputability for Hemovigilance Reporting

A recording is available of the June 5 AABB audioconference on deciphering imputability — the strength of the relationship of the transfusion to the reaction — and how crucial it is to understanding adverse reactions. Presenter Michele Herman, BS, MT(ASCP), defined imputability; discussed the importance of its inclusion in adverse reaction reports; explained the difference among case definition, severity and imputability within the context of the NHSN; and described the options for imputability. The audioconference also explored how to use patient records to assign imputability according to the NHSN surveillance protocol.


WEST NILE VIRUS BIOVIGILANCE

JAMA: West Nile Virus Now Endemic Throughout Contiguous United States

In the July 17 issue of JAMA, results from a literature review by L.R. Petersen et al. show that West Nile virus now is endemic throughout the contiguous United States. "To date, incidence is highest in the Midwest from mid-July to early September," the authors noted. The researchers concluded that West Nile virus will remain a formidable public and clinical health problem in North America for many years.

Blood centers are encouraged to monitor the AABB West Nile Virus Biovigilance Network — including maps and reports* updated in real time — for activity in their region and guidance on triggering individual nucleic acid testing, or ID-NAT. Those who enter data are reminded to note presumed viremic donations, or PVD, as "cannot conclude" if there is not a final interpretation when data are entered and then update the PVD record upon receipt of confirmatory results. Unless a final interpretation attribution is entered, the PVD will not appear on the map. Questions about the network should be sent to the AABB Center for Data and Special Programs.


AABB Issues Association Bulletin; Updates Recommendations for WNV Testing

The AABB Board of Directors has approved recommendations of the AABB Transfusion-Transmitted Diseases Committee that address criteria for nucleic acid testing, or NAT, for West Nile virus, or WNV. Published in Association Bulletin #13-02*, the revisions update previous criteria used to initiate the conversion from mini-pool-NAT, or MP-NAT, to individual-donation-NAT, or ID-NAT — also known as triggering — and the transition back to MP-NAT — or detriggering — once WNV activity has stopped. The recommendations are based upon WNV data collected from 2003 to 2012 and are intended to ensure that all establishments are prepared to implement triggering or detriggering appropriately, and to facilitate sharing of WNV donor screening data among facilities in the U.S. and Canada enabling timely conversion from MP-NAT to ID-NAT in WNV-affected areas. AABB recommends establishments begin triggering and detriggering based upon criteria listed in the bulletin. Centralized facilities and their customers should agree upon the criteria used to make the decision to trigger or detrigger so testing laboratories may take appropriate action once a presumed viremic donation, or PVD, is reported. According to the bulletin, the increased refinement of these recommendations will "reduce the residual risk of WNV transmission through blood transfusions." Additionally, AABB recommends that facilities monitor WNV activity in real time, initiating conversion from MP-NAT to ID-NAT promptly — ideally within 24 hours of receiving test results and no later than 48 hours from collection of the most recent WNV-reactive donation or PVD responsible for the trigger.

The bulletin recommends that establishments within collection regions collaborate to communicate reports of PVDs and WNV-reactive donations to AABB's WNV Biovigilance Network. The authors cite past success of a similar strategy to enable collection regions to respond quickly to WNV activity. Individuals should contact AABB's WNV Biovigilance Network for assistance with reporting information or to update lab contact information.

"Questions and Answers" regarding the bulletin are available on AABB's website.* The Q-and-A document offers responses to questions AABB members have posed and includes the rationale for the revisions, a summary of changes made to previous criteria, and answers related to reporting presumed/potentially viremic or West Nile virus-reactive donations to the AABB West Nile Virus Biovigilance Network.


ORGAN BIOVIGILANCE

HHS Releases Guideline for Organ Donor Screening

The U.S. Department of Health and Human Services has released a new guideline aimed at improving patient safety by reducing disease transmission through organ transplantation. According to an HHS press release, the new guideline "updates the 1994 U.S. Public Health Service (PHS) guideline for preventing transmission of human immunodeficiency virus (HIV) through organ transplantation and adds guidance for reducing unexpected transmission of hepatitis B virus (HBV) and hepatitis C virus (HCV) through organ transplants." In the guideline, the CDC-led HHS work group that developed the recommendations calls for the use of more sensitive tests to better help patients and physicians understand the benefits and risks associated with the transplantation of a specific organ.


IN THE NEWS

'Transfusion' Study Suggests Blood Donation Does Not Lower Risk of CHD

In the June issue of "Transfusion," the results from a study by M. Germain et al. suggest that blood donation does not lower the risk of coronary heart disease, or CHD. In the investigation, whole blood donors who were permanently disqualified because of false-reactive test results were compared with donors who remained eligible. The authors stated that their study "can be seen as conceptually equivalent to a randomized experiment, assuming that false reactivity to a [transmissible disease] marker represents a chance event, unrelated to the risk of CHD." Compared with the donors who were permanently disqualified, those who remained eligible did not have a lower risk of CHD. The authors stated that the study results do not support the "iron hypothesis" — the idea that iron plays a role in the pathogenesis of CHD and that decreased iron stores should reduce the risk of the disease. Continuing medical education credits are being offered for reading and successfully completing a test on the article.


Transfusion News Video Highlights Transfusion-Transmitted Hepatitis B From Donors With Occult Infection

A video posted on the Transfusion News website features two studies on transfusion-transmitted hepatitis B from donors with occult hepatitis B infection, or OBI — defined in the July issue of "Transfusion" as serologically undetectable hepatitis B virus surface antigen, or HBsAg, in spite of the presence of circulating HBV DNA. In their European-based study, featured in the July issue, J. Allain and colleagues found that blood products from OBI donors carry a high risk of HBV transfusion transmission that is dependent on the presence of antibody to HBsAg, or anti-HBs, and viral dose. Additionally, the authors indicated that screening for antibodies to HBV core antigen, or anti-HBc, and HBV nucleic acid testing, or NAT, may be a justifiable safety measure, depending on epidemiology.

In the second study, also in the July issue of "Transfusion," R. Taira et al. evaluated the impact of individual-donation NAT, or ID-NAT, on transfusion-transmitted HBV, or TT-HBV, from donors with OBI in Japan. The authors found that 85 percent of TT-HBV infections that arose from OBI donations would have been prevented by ID-NAT. They further noted that ID-NAT showed that 1.94 percent of donations with low anti-HBc and anti-HBs titers were viremic and that there was no correlation between anti-HBc titers and the frequency of viremia. They concluded that "[t]he elimination of all donations with low anti-HBc and anti-HBs titers would be important to any strategy aimed at preventing OBI-related TT-HBV infections in countries … that have a slightly elevated HBV prevalence in blood donations."

In an editorial in the issue, C. Bianco and R. Dodd state that "[t]he issue that we are still confronting with OBI is that we do not know its actual prevalence among blood donors and its contribution to the residual risk of [TT-HBV] in most regions of the world." They caution that the present studies "contain suggestions that are applicable to the authors' settings, but cannot be comfortably generalized and do not allow construction of clear protocols for donor screening applicable everywhere because of the wide differences in burden of infection and disease in many countries."


Recent Issue of 'AABB News' Explores Use of Patient-Centric Data Metrics to Improve Care

The July issue of "AABB News*" explores the role of patient-centered outcomes-based research — which incorporates metrics such as survival, health-related quality of life and severity of symptoms — in helping improve care at the bedside. Several outcomes-based studies are examined in detail within this issue. Additionally, one article highlights a provision of the Affordable Care Act that requires any hospital with more than 50 beds to have a contract with a patient safety organization, such as the AABB Center for Patient Safety.


*AABB member-only content.

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