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Biovigilance Update - Spring 2017


Spring 2017


First US AABB Hemovigilance Symposium Takes Place in Atlanta »

Researchers Propose Revised TRALI Nomenclature »

Update on Massachusetts’ Adoption of Electronic Blood Bank Reporting »

Hemovigilance Coding Case Study »

CDC Updates NHSN Hemovigilance Module »

CDC Revises NHSN Blood Safety Website »

AABB Posts Association Bulletin #17-02 on Managing Donor Iron
Level »

AABB Invites Hospital Blood Collectors to Join Donor Hemovigilance and Engage in Benchmarking »


First US AABB Hemovigilance Symposium Takes Place in Atlanta

AABB hosted the first annual United States Hemovigilance Symposium February 13-14 in Atlanta. More than 100 blood center and transfusion professionals — including many representatives from the U.S. public and private sectors — attended the event. Hemovigilance and blood safety surveillance experts, including officials from the Food and Drug Administration, the Centers for Disease Control and Prevention and the state of Massachusetts, shared practical experiences and discussed current research in the field. International speakers described hemovigilance systems in the United Kingdom, Canada and France, attributing success largely to the active engagement and participation of hospitals and subject matter experts. Presentations at the symposium covered the hemovigilance components of the Recipient Epidemiology and Donor Evaluation Study (REDS-III) program and the Transfusion Transmitted Infections Monitoring System (TTIMS) funded by FDA and the National Heart, Lung, and Blood Institute. Speakers highlighted global achievements in hemovigilance, provided insight on recommendations from hemovigilance systems that have successfully impacted transfusion practices and patient care, discussed barriers to participation in U.S. hemovigilance and other systems, and addressed a vision for the future of U.S. Hemovigilance.


Researchers Propose Revised TRALI Nomenclature

Pearl Toy, MD, Steven Kleinman, MD, and Mark Looney, MD, advise adopting the designation “transfused acute respiratory distress syndrome” (Transfused ARDS) for the condition currently identified as “possible transfusion-related acute lung injury” (TRALI) in an Early View “Transfusion” commentary. The researchers, who chaired the committee that developed the first standardized clinical definition of TRALI 10 years ago, argue that TRALI and possible TRALI are different conditions that follow different etiologies. Further, research suggests that Transfused ARDS is more likely to be caused by alternative risk factors than transfusion. Those risk factors include shock, aspiration, sepsis, pneumonia, high-risk surgery and high-risk trauma. Based on evidence confirming that “TRALI is often due to transfusion of white blood cell antibodies to at-risk patients,” the authors recommend the continuing usage of the term “TRALI, antibody mediated.” In non-antibody mediated cases of TRALI, because research has not confirmed specific non-antibody transfusion factors, they support the diagnosis of “TRALI, non-antibody mediated” in the applicable cases.

Update on Massachusetts’ Adoption of Electronic Blood Bank Reporting

A commentary in “Transfusion” details how the Commonwealth of Massachusetts implemented electronic reporting of hospital blood bank activity and transfusion-related adverse events through the National Healthcare Safety Network (NHSN). More than 17,000 health care facilities in the U.S. currently report patient safety information — mainly hospital acquired infections data — through the NHSN, a secure, web-based surveillance system operated by the CDC. The NHSN’s Biovigilance Component contains the Hemovigilance Module, a repository of information about transfusion-related adverse events and incidents and monthly transfusion statistics.

Massachusetts hospital blood bank employees, who previously reported information on paper, now report it electronically through the NHSN Hemovigilance Module. To comply with state regulations, hospitals share the reported information with the Massachusetts Department of Public Health. The data must conform to detailed surveillance definitions for both denominator and adverse reaction data. Once the data has been entered, users can compare it with aggregate state and national data and use it to identify potential areas for improvement. Participants can also share their hospital’s data with external organizations, such as patient safety organizations.

The article describes the history of blood banking regulations in Massachusetts, beginning with the first reporting requirements in 1950, continuing through Feb. 20, 2015 — when all 69 hospital blood banks in Massachusetts had begun reporting data through the NHSN Hemovigilance Module — and proceeding into the present. It also discusses an October 2015 report on the first 12 months of reporting, including a summary of statewide facility characteristics and descriptive statistics on denominator data and adverse events stratified by facility transfusion volume.

Hemovigilance Coding Case Study

AABB welcomes the submission of adverse reaction and/or incident cases to be classified and shared with those with an interest in hemovigilance.

A 60 year old man with transfusion dependent thalassemia was in his usual state of health when he presented for his regular outpatient transfusions. He was routinely transfused every 3 weeks with 3 units of RBCs. He received 3 units of RBCs uneventfully with stable vital signs. Immediately after the transfusion, the patient was noted to be pacing and complained of leg cramps. The patient was asked to remain in the outpatient transfusion unit and over the next 10 minutes his leg cramps worsened and he became increasingly short of breath. The bags that contained the transfused RBC units were retrieved and cultures were performed. Shortly after that he developed rigors and hypotension and was admitted to the ICU where he later developed a fever and his blood was cultured. Over the next three days he was aggressively treated for sepsis, respiratory failure, hypotension, renal failure, and disseminated intravascular coagulation (DIC). He did not respond to therapy and died 3 days following the transfusion.

The patient’s blood culture collected three hours following the transfusion and the third RBC unit that was transfused each grew gram negative rods that were subsequently identified to be Pseudomonas fluorescence by mass spectroscopy. The first two RBC units that were transfused had negative gram stains and cultures.

Reaction Categorization

  • For entry into the CDC NHSN Hemovigilance Module, this reaction was classified as a Transfusion Transmitted Infection (TTI).

  • The case definition was DEFINITIVE based on the availability of laboratory evidence that the patient was infected with Pseudomonas fluorescence.

  • Since the patient died from the infection and associated complications, the severity of this case was DEATH, in some systems this is a Grade 4 event.

  • The imputability of the reaction to the transfusion was DEFINITE based on the following four factors:

    • The pathogen was present in the transfused component AND

    • No other potential exposures to the pathogen were identified in the recipient AND

    • The patient had no clinical signs of an infection prior to transfusion AND

    • The pathogenic strains in the patient and transfused unit were identical as determined by mass spectroscopy.


CDC Updates NHSN Hemovigilance Module

The CDC released an update for the National Healthcare Safety Network’s Hemovigilance Module on Jan. 7. The update includes a new NHSN layout, a revised adverse reaction reporting screen, a new option to enroll as a non-acute care facility and the ability to electronically report denominator data using Clinical Documentation Architecture (CDA). Additionally, CDC added new and revised documentation to the NHSN Blood Safety website, including protocol, forms and trainings.

Specifically, CDC modernized all the components of the NHSN user interface to improve user experience and simplify data entry. CDC updated the Hemovigilance Adverse Reaction form to enable more accurate and complete data collection. In addition, CDC added sections for medical and transfusion history and for documenting treatments for adverse reactions. The agency also modified the component detail and outcome sections, making the adverse reaction paper form reaction-specific and adding reaction-specific signs, symptoms and lab results to the Reaction Details section.

In response to user requests and feedback, CDC developed electronic reporting for Hemovigilance Module denominator data through CDA. The new electronic reporting, which will replace the current method of manual data entry, is expected to decrease the reporting burden, improve data quality and increase data granularity by allowing for rate calculations by product type and combining collection method and modification. To participate in electronic reporting via CDA, facilities need to build the corresponding software component to enable communication with CDC’s CDA component. For more information, please refer to the NHSN Blood Safety Surveillance website and the NHSN CDA website.

The CDC now allows non-acute care facilities to participate in the Hemovigilance Module. Long-term care facilities and ambulatory facilities — including hemodialysis and outpatient surgery facilities — can enroll in or activate the Hemovigilance Module to begin reporting data and take part in a new Annual Facility Survey for non-acute care facilities.

In response to CDC’s release on Jan. 7, AABB requested that CDC roll back the system changes to the previous version and include stakeholders and users in design of future changes to the module (letter found here). In response to AABB and user feedback, some of the newly required fields have been made optional rather than required and the technical errors reported by users have been repaired. You can find the document with further information on which questions were made optional here.

CDC Revises NHSN Blood Safety Website

CDC added new and updated training modules to the NHSN Blood Safety Surveillance website. New resources include a self-paced, on-demand interactive Hemovigilance (HV) 101 training (Lectora) with available CEU credit; five short audiovisual presentations that review specific forms and topics; and updated Quick Reference Guides. New guidance for the Denominator Form regarding discarded blood units will also be available, as well as annotated forms with variable names for each question and an updated data dictionary.


AABB Posts Association Bulletin #17-02 on Managing Donor Iron Level

AABB released Association Bulletin (AB) #17-02, Updated Strategies to Limit or Prevent Iron Deficiency in Blood Donors. AB #17-02 supersedes AB #12-03. Developed by the AABB Donor Health and Safety Committee and approved by the AABB Board of Directors, the bulletin recommends actions to prevent or mitigate postdonation iron deficiency. It provides information from multiple studies demonstrating that certain subgroups of blood donors — young donors, premenopausal females, frequent donors and donors with hemoglobin (Hb) levels near the cutoff — are at increased risk of developing iron deficiency. The bulletin also presents operationally feasible options to address the iron loss associated with donation. The recommendations include using comprehensive donor education materials, combining specific interventions for at-risk donors and postimplementation monitoring to evaluate the strategies.

AABB Invites Hospital Blood Collectors to Join Donor Hemovigilance and Engage in Benchmarking

Blood centers engage in hemovigilance to reduce adverse events associated with blood donation and to improve patient safety. AABB’s Donor Hemovigilance program enables participating facilities to identify trends by monitoring and analyzing their donor data, benchmarking it against aggregate data from the program, and tracking reactions across facilities, regions and the nation. Membership confers access to the Donor Hemovigilance Analysis and Reporting Tool, or DonorHART, which facilitates data entry and analysis. Participants will use the internationally harmonized definitions and have access to in-depth system-level reports. Additional information about the Donor Hemovigilance program, including membership benefits and enrollment instructions, is available on the AABB website.


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Roubinian, N. H., Hendrickson, J. E., Triulzi, D. J., Gottschall, J. L., Chowdhury, D., Kor, D. J., Looney, M. R., Matthay, M. A., Kleinman, S. H., Brambilla, D., Murphy, E. L. and the NHLBI Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) (2017), Incidence and clinical characteristics of transfusion-associated circulatory overload using an active surveillance algorithm. Vox Sang, 112: 56–63. doi:10.1111/vox.12466

Toy, P., Kleinman, S. H. and Looney, M. R. (2016), Reply to concerns regarding dropping the term “possible TRALI”. Transfusion, 56: 2394–2395. doi:10.1111/trf.13734

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Yanagisawa, R., Takeuchi, K., Kurata, T., Sakashita, K., Shimodaira, S., and Ishii, E. (2016) Transfusion-related acute lung injury in an infant. Pediatrics International, 58: 543–544. doi: 10.1111/ped.12951