Biovigilance Update - Fall 2015

 Visit aabb.org/biovigilance

FALL 2015

IN THIS ISSUE

Hemovigilance Activities at 2015 AABB Annual Meeting »

AABB and Emory Announce Web Software Application to Promote Accurate Diagnosis of Transfusion Reactions »

2014 SHOT Report Details Transfusion-Related Events in UK »

CDC Updates NHSN Hemovigilance Module »

TSOs Improve Transfusion Safety at Dartmouth-Hitchcock Medical Center »

Case Review of TACO Finds Increased Risk With Old Age, Pretransfusion Diuretics »

Study Finds No Increase in Adverse Outcomes With Transfusion of Older Blood »

Facilities Encouraged to Join AABB Donor Hemovigilance
Program »

DonorHART Software Updated to Enable Collection Center-Level Reports »

Upper-Extremity Deep Venous Thrombosis May Be More Common Than Thought »

Basing Minimum Donation Intervals on Prior Hb Levels May Decrease Deferral Rates, According to Researchers »

AABB HUB Provides Online Collaborative Space »

FDA Releases Summary of FY 2014 Fatalities Following Blood Collection and Transfusion »

FDA Issues Draft Guidance Revising Recommendations for Reducing Risk of Transfusion-Transmitted HIV »

BPAC Supports Year-Round, Nationwide Antibody Testing for Babesia »

FDA Advisory Committee Favors Changes to vCJD Deferral
Policy »

TOP NEWS

Hemovigilance Activities at 2015 AABB Annual Meeting

The 2015 AABB Annual Meeting will be the site of numerous activities related to hemovigilance. The Thursday afternoon preconference workshop, Introduction to Hemovigilance, will provide instructions on getting started with hemovigilance, including how to begin using hemovigilance definitions, how to enroll in the Centers for Disease Control and Prevention’s National Healthcare Safety Network Hemovigilance Module and how to participate with the AABB Center for Patient Safety.

Members of the AABB Center for Patient Safety, AABB’s component Patient Safety Organization (PSO), are invited to join confidential “Safe Table” discussions at the annual meeting. Additional information and instructions on joining are available on the Center for Patient Safety Web page and by emailing hemovigilance@aabb.org.

During the “Revenge of the Hemovigilance Experts” session, to be held on Sunday, Oct. 25, panelists will challenge audience members to analyze and code perplexing transfusion reactions submitted by members; cases can be submitted for consideration through AABB’s “Ask the …” Sessions Web page.

Educational sessions will address using electronic donor health questionnaires to improve blood safety and screening prospective blood donors with ferritin tests. Another session will describe how donor hemovigilance data is being used around the world to improve donor safety and review national and international donor hemovigilance interventions currently in use.

The Hemovigilance area at AABB Central will offer demonstrations of the new Center for Patient Safety Hemovigilance Portal, Donor Hemovigilance Analysis and Reporting Tool (DonorHART) software and the CDC’s NHSN Hemovigilance Module. The Hemovigilance Schedule-at-a-Glance, which will be available shortly on the Annual Meeting Web page, provides additional information about hemovigilance activities at the annual meeting.


RECIPIENT HEMOVIGILANCE

AABB and Emory Announce Web Software Application to Promote Accurate Diagnosis of Transfusion Reactions

AABB and Emory University have released Transfusion Reaction Differential Diagnosis (TrDDx), an online application developed by Emory to help clinicians accurately diagnose transfusion reactions to blood products. The tool uses hemovigilance definitions developed jointly by AABB and the U.S. Department of Health and Human Services and used in the National Healthcare Safety Network. The tool, which uses a proprietary algorithm, guides users through a set of simple questions posted on checklists. Users check off symptoms they have observed and the time when symptoms appeared. As users respond, the algorithm narrows down the set of potential diagnoses until only the one that is most consistent with the users’ responses remains. Users can download the application onto their smartphone. AABB and Emory University caution that the algorithm is only a tool and that clinicians should compare the results against the NHSN protocol.


2014 SHOT Report Details Transfusion-Related Events in UK

The number of deaths definitely, probably and possibly related to transfusion in the United Kingdom dropped by almost a third — down from 22 to 15 — between in 2013 and 2014, according to the 2014 annual report published by the Serious Hazards of Transfusion, or SHOT, organization. SHOT is the UK’s independent, professionally-led hemovigilance program. Since 1996, SHOT has been collecting and analyzing anonymized information on adverse events and reactions in blood transfusion from all health care organizations involved in the transfusion of blood and blood components in the U.K. In the 2014 report, SHOT recommends that “never events” begin including all ABO-incompatible transfusions (all components), not only those which result in death or serious harm, because they “may be fatal and are absolutely preventable.” The 2014 report also contains a chapter on human factors based on the observation that the majority of reports continue to follow mistakes (often multiple) in the transfusion process (77.8 percent). Mistakes are grouped by category, such as errors in identification, communication and documentation. The authors note, “We have observed a worrying number of adverse reactions and events related to poor clinical decisions.” While the number of laboratory errors has not changed, the number of reports with an information technology element has increased.


CDC Updates NHSN Hemovigilance Module

The Centers for Disease Control and Prevention released version 8.4 of its National Healthcare Safety Network (NHSN) on July 25 with updates to the Hemovigilance Module. In the Investigate Results section of the Incident Reporting Form, the CDC no longer requires entry of incident root cause analysis results. This is now an optional field. Additionally, the NHSN Hemovigilance Module website has migrated to a new, mobile friendly platform. The new accordion-style format allows for easy navigation between areas of the website. Users may notice two new sections: Quick Reference Guides and Analysis Resources. In addition, customizable forms are available for download. Please visit the website at cdc.gov/nhsn for more information. Contact nhsn@cdc.gov with any questions and write “Biovigilance” in the subject line for a faster response.


TSOs Improve Transfusion Safety at Dartmouth-Hitchcock Medical Center

One of the roles of hospital transfusion safety officers, or TSOs, is to improve transfusion safety after blood leaves the laboratory. Their duties include observing the transfusion process from start to finish, from patient identification to reporting of transfusion reactions. TSOs identify areas for improvement, propose quality enhancement measures, educate staff members and promote evidence-based strategies to improve transfusion practice and ensure patient safety. Patient blood management (PBM), an evidence-based, multidisciplinary approach to optimizing the care of transfusion patients — including reducing unnecessary transfusions — has become a valuable tool for TSOs.

As documented in an Early View article in “Transfusion,” the Dartmouth-Hitchcock Medical Center has employed a TSO since 2001, when James P. AuBuchon, MD, FCAP, FRCP, then medical director of the Dartmouth-Hitchcock Blood Bank and Transfusion Service, convinced hospital administrators of the need for and benefits of the position. The first TSO was hired to extend the transfusion medicine service quality plan to the bedside, reduce errors, improve patient safety, reduce unnecessary blood component utilization and product wastage, educate hospital staff and improve communication between clinical providers and transfusion service staff.

There is currently no formal certification required for TSOs, who can come from clinical or laboratory backgrounds. Potential TSOs need strong communication and collaboration skills, persistence and patience. They also need background knowledge of blood collection, processing, safety and management. The TSO training program at Dartmouth-Hitchcock covers transfusion operations, policies and procedure; blood utilization; perioperative blood management; quality assurance and event reporting; infectious disease management; transfusion reaction evaluation, management and reporting; and introductions to key stakeholders, including clinical staff, educators, coordinators and department directors. There, the TSO serves as the primary liaison between the transfusion laboratory and clinical care areas.


Case Review of TACO Finds Increased Risk With Old Age, Pretransfusion Diuretics

In a “Transfusion” article reviewing cases of transfusion-associated circulatory overload (TACO) reported to the Irish Blood Transfusion Service between 2000-2010, researchers found that the majority of cases of TACO occurred in elderly patients ages 70 years or older. Patients of all ages can develop the complication, with risk decreasing with younger age. The study showed that patients who received diuretics prior to transfusion were at increased risk of mortality, as compared with those who received them during or after transfusion. Beginning in 2007, hemovigilance officers began reporting cases in which error contributed to severe transfusion-related reactions. Twenty percent of TACO cases reported after 2007 involved human error. The study shows that the overall incidence of TACO decreased between 2001 and 2010, a change the authors attribute to efforts to educate providers on the appropriate use of plasma. The researchers concluded, however, that underreporting of TACO may limit the study’s findings.


Study Finds No Increase in Adverse Outcomes With Transfusion of Older Blood

An observational study of maternity patients who received transfusions showed no relationship between the storage age of red blood cells transfused and adverse outcomes following transfusion. In an Early View article in “Transfusion,” researchers analyzed routinely collected data about the women’s characteristics, transfusions and outcomes and used generalized propensity score methods — with storage age of blood as a continuous measure — to reduce the effect of confounding factors. The study included 2,990 women who received one to four units of red blood cells while hospitalized to give birth in New South Wales, Australia between July 2006 and December 2010. The primary adverse outcome measure was severe maternal morbidity; the secondary one was hospital readmission. The researchers used a composite indicator as a measure of severe maternal morbidity. The indicator included sepsis, thromboembolic events, organ dysfunction, shock, cardiac arrest, cerebral edema, coma, cerebral-vascular accident, assisted ventilation, dialysis or death within 12 months. They evaluated hospital readmissions that occurred within six weeks of discharge. The storage age of blood was calculated as the difference between the collection and transfusion date; in cases of multiple transfusions, the storage age of the oldest blood was used. Units of blood in New South Wales are leukoreduced and expire after 42 days. The median storage age of blood used during the study was 20 days, and the median number of units transfused was two.


DONOR HEMOVIGILANCE

Facilities Encouraged to Join AABB Donor Hemovigilance Program

AABB encourages blood collection facilities to enroll in the AABB Donor Hemovigilance Program to help reduce the occurrence of adverse events associated with blood donation and to improve overall donor safety. Program participants gain access to internal benchmarking and national averages using internationally consistent definitions for adverse reactions; in-depth, expert analysis; risk mitigation; and a better understanding of rare but serious adverse donor reactions. To enroll in the program, facilities must complete the enrollment form, download the user manual and agree to adopt standard definitions or map definitions to international standards for donor reactions. A tiered annual pricing program that aligns with a facility’s number of blood collection procedures is available.

Participants report adverse donor reactions through the Donor Hemovigilance and Analysis Reporting Tool, or DonorHART, which allows users to analyze and view donor hemovigilance data. Collection facility staff can enter adverse reaction reports and denominator data manually or upload .csv files. Once populated, the system can generate tables, reports and graphics to show granular detail about adverse reactions, demographics and pertinent rates. Collection facilities that wish to participate in donor hemovigilance, but do not yet gather all of the information used in the full software program, can enter data into a critical subset of the fields through the DonorHART Lite system. For additional information or to join the program, contact AABB's Department of Research and Data Analysis at +1.301.215.6588 or hemovigilance@aabb.org.


DonorHART Software Updated to Enable Collection Center-Level Reports

Knowledge Based Systems Inc. has updated its Donor Hemovigilance Analysis and Reporting Tool (DonorHART) to support denominator data at the collection center-level. The system allows blood centers to capture and analyze information on donor reactions and reaction rates at sub-sites within their organization. The updated version allows users to generate reports and conduct analysis based on what has been entered for each of their collection centers. The previous version only allowed organization-level reports. Additional information about the AABB Donor Hemovigilance Program is available online or by contacting Barbee Whitaker, PhD, at hemovigilance@aabb.org.


Upper-Extremity Deep Venous Thrombosis May Be More Common Than Thought

While thought to be rare, upper-extremity deep venous thrombosis (UEDVT) following blood donation may actually be underreported in English-language medical literature. Only two cases of UEDVT after whole blood donation have been documented in the literature. An analysis published in the June issue of “Transfusion” provides a discussion of three such cases that occurred at a single institution over a three-month period. The authors also examine cases in earlier literature and a recent Australian study of 20 cases that resulted from 4.2 million whole blood donations.

The researchers hypothesize three possible explanations for underreporting of UEDVT cases in the medical literature. Blood centers may not recognize UEDVT because they lack a biovigilance system. Alternately, blood centers with a system in place might not distinguish cases as separate adverse events. Lastly, blood centers may not be aware that these cases should be reported.

The authors note several commonalities among the reported cases: Patients generally presented with arm pain, swelling and bruising. Venous obstruction was almost always identified using ultrasound. All patients were treated with anti-coagulants. Initial treatment was typically low-molecular-weight heparin or unfractionated heparin. Finally, patients were transitioned to anti-vitamin K therapy (usually warfarin).

Venous cannulation — including blood donation — is known to cause secondary UEDVT. The researchers conclude that “Twenty-four of 25 donors did well after anticoagulation. None of the donors developed a post-thrombotic syndrome or any long-term sequellae, but one donor was placed on long-term aspirin.”


Basing Minimum Donation Intervals on Prior Hb Levels May Decrease Deferral Rates, According to Researchers

A study published recently online in “Transfusion” Early View provides evidence that minimum donation intervals of 56 days are only sufficient for donors with hemoglobin (Hb) levels that far exceed the donation cutoff level, i.e. by at least 0.3 mmol/L. The data show that donors with Hb levels below that are deferred at rates of greater than 10 percent. Researchers analyzed Hb levels, donation intervals and relevant donor characteristics for more than 220,000 Dutch individuals who donated whole blood at least twice between 2005 and 2009. They categorized donation intervals into periods of shorter than three months, three to six months, six to 12 months and longer than 12 months. They also compared Hb level at previous donation (or visit, for donors who were deferred) and length of interval between donation/visit and an outcome visit — a randomly selected visit in 2009 or the last visit for donors who had stopped donating in 2007 or 2008.

The investigators found that deferral rates are highest for donors with lower Hb levels at their previous donation and shorter donation intervals. Both men and women experience three times higher deferral rates with donation intervals shorter than three months, compared to intervals longer than a year. In addition, both men and women with Hb levels below the cutoff at their previous visit are deferred at rates higher than 10 percent at their following visit, regardless of donation interval. In order to prevent future Hb deferrals, those who are deferred due to low Hb level should not donate for at least a year following the deferral, according to the researchers.


BIOVIGILANCE

AABB HUB Provides Online Collaborative Space

AABB has integrated the best features and functionality of popular social media platforms into its new online collaborative space, the AABB HUB. The HUB offers members access to discussion groups that focus on a number of topics, including transfusion medicine, hemovigilance and regulatory issues. Members can subscribe to one or more discussion groups to receive email alerts when new threads are posted and reply to posts directly from their email inbox. The Hemovigilance forum currently contains threads on the 2014 Serious Hazards of Transfusion (SHOT) Report, the benefits of international harmonization of donor hemovigilance definitions and the new transfusion reaction diagnosis app, TrDDx. The AABB HUB enables participants to ask and answer questions, share ideas and network with colleagues from across the United States and around the world.


FDA Releases Summary of FY 2014 Fatalities Following Blood Collection and Transfusion

The FDA released a summary of fatality reports submitted during fiscal year 2014. The summary details 68 fatalities associated with transfusion and donation of blood during Oct. 1, 2013-Sept. 30, 2014. It shows the U.S. blood supply to be safer than at any point to date, with a decrease in transfusion-related and potentially transfusion-related fatalities. According to FDA, the improved safety of the blood supply reflects advances in donor screening and testing, automated data systems and transfusion medicine combined with voluntary measures taken by the transfusion community.

FDA concluded that not all fatalities in the summary resulted from transfusion or donation. Of those that were transfusion-related, the highest number of recipient fatalities were due to transfusion-related acute lung injury (TRALI). FDA determined that only one of the nine donor fatalities in the summary was caused by the donation. In that case, a whole blood donor fell backward and sustained a traumatic brain injury that ultimately resulted in death.

The summary also contains combined data from the past five fiscal years, during which the greatest number of recipient fatalities were caused by TRALI (41 percent), followed by transfusion-associated circulatory overload (22 percent), hemolytic transfusion reaction (21 percent) and microbial infection (eight percent).

Overall, data from the summary shows that blood collection and transfusion remain extremely safe. For example, while there were approximately 21 million transfusions of blood components in 2011, FDA received reports of 58 transfusion-related and potentially transfusion-related fatalities during the proximate period of FY 2011. The numbers of reported fatalities decreased in the following years: 65 fatalities reported in FY 2012, 59 in FY 2013 and 56 in FY 2014.

Hospitals are encouraged to report transfusion reactions through the National Healthcare Safety Network's Hemovigilance Module and to join AABB's group within the module to receive analyses of their data. Fatal reactions must be reported to FDA; reporting instructions are available online. In addition, facilities that join the AABB Center for Patient Safety gain access to confidential data analysis of adverse reactions that can help them design interventions to improve patient safety.


TRANSFUSION-TRANSMITTED INFECTIONS

FDA Issues Draft Guidance Revising Recommendations for Reducing Risk of Transfusion-Transmitted HIV

In May, the Food and Drug Administration released a draft guidance, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” The guidance contains recommendations that, if finalized as drafted, will change the current lifetime blood donation deferral for men who have sex with men, or MSM, to a one-year deferral period. Other recommendations included in the draft guidance will supersede the 1992 Memorandum “Revised Recommendations for the Prevention of HIV Transmission by Blood and Blood Products.” In response, AABB, America’s Blood Centers and the American Red Cross issued a joint statement reiterating their long-time support of a one-year deferral period and affirming their plan to review the document and respond during the 60-day comment period.

AABB provided comments to FDA in July supporting the proposed changes to the deferral period for blood donation and objecting to FDA’s plan to recommend providing donors with educational materials listing “the signs and symptoms associated with HIV infection…” AABB finds this recommendation to be obsolete and the current “signs and symptoms” nonspecific. In addition, the availability of more sensitive and specific serological tests and nucleic acid amplification assays diminishes the relevance of the recommendation. AABB supports deleting the “signs and symptoms” information in the donor educational materials and adding questions about risk factors for contracting HIV to the donor history questionnaire. AABB will continue to work with other stakeholders to educate the public about this evolving issue.


BPAC Supports Year-Round, Nationwide Antibody Testing for Babesia

The Blood Products Advisory Committee (BPAC) voted in favor of year-round, nationwide antibody testing of blood donors for Babesia microti after hearing the results of two investigational studies and presentations from FDA at a May 13 meeting. The Committee also voted that nucleic acid testing (NAT) should be performed in certain high-risk states. Eight panel members and the nonvoting industry representative voted in favor of NAT testing in nine states known to be endemic: CT, MA, ME, MN, NH, NJ, NY, RI and WI. Six members voted in favor of testing in 15 states plus the District of Columbia — attaining the largest risk capture with the smallest number of states. This option would include DE, FL, MD, PA, VA and VT, in addition to DC and the states listed above. Members suggested that data from antibody testing could be used to indicate when additional states should implement NAT testing. Asked to comment on whether it would be appropriate to apply a time-based deferral for donors testing positive for B. microti, several committee members noted that, based on data presented at the meeting, many donors would likely have detectable antibodies well beyond a year. They suggested repeat testing at two years or more. To date, the antibody tests described at the BPAC meeting have not been licensed. AABB presented statements to BPAC, as did America’s Blood Centers, supporting regional testing and opposing the use of unvalidated CMS data as the basis for FDA policy on blood donor testing.


FDA Advisory Committee Favors Changes to vCJD Deferral Policy

The FDA’s Transmissible Spongiform Encephalopathies Advisory Committee met on June 1 and voted in favor of changing the current donor deferral policy for variant Creutzfeldt-Jakob disease (vCJD). The current policy, presented to the committee as Option 1, states that individuals who have spent three months or longer in the U.K. between 1980 and 1996 are not eligible to donate blood. Those who have spent a cumulative period of five years or longer in Europe between 1980 to the present are similarly ineligible. Based on a new geographic risk assessment model that recognizes that 95 percent of the U.S. blood supply is voluntarily leukoreduced, FDA proposed a modified plan (Option 2) that maintains the current policy for time spent in the U.K. but lifts the deferral for time spent in other European countries, excluding Ireland and France. The risk period for Ireland and France would be changed to 1980-2001. While the majority of committee members voted against Option 2, they agreed unanimously that the current policy should be modified. Members concurred that other countries besides the U.K., France and Ireland pose an exposure risk that should be evaluated. The committee voted overwhelmingly in favor of universal leukoreduction of blood products.

AABB joined ABC, the ARC and the Armed Services Blood Program in issuing a joint statement in support of Option 2. The statement notes that this approach “will provide similar risk reduction for transfusion-transmitted vCJD as the current policy,” and that the proposed limit for time spent in France and Ireland aligns with the period of exposure to bovine spongiform encephalopathy in those countries. The organizations encouraged FDA to collaborate with colleagues in the military, so they can consider data on individuals associated with U.S. military bases in Europe during 1980-1996 when deciding future policy.