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Hemovigilance Update - Fall 2017

Hemovigilance Updates
FALL 2017
IN THIS ISSUE
Upcoming Events
A Hemovigilance Interview with Baystate Medical Center

AABB is starting a series of interviews with notable hemovigilance experts . This is the first of the series, an interview with Lynne O’Hearn, MT(ASCP) (LOH below), transfusion safety officer at Baystate Medical Center, in Springfield, Massachusetts. O’Hearn works with Dr. Chester Andrzejewski in the department of transfusion medicine. The Baystate Medical Center has been integral in the growth of hemovigilance in Massachusetts.

AABB:    How did your facility get started with hemovigilance?

LOH:      Our hospital was very interested in participating so we investigated the process, then set participation as one of our annual goals. We met that goal in July 2011.


AABB:   How did the Massachusetts mandate, which made reporting to CDC NHSN mandatory, impact your facility’s participation in the AABB Center for Patient Safety?
LOH:      We are a health system, but only our larger hospital had been participating prior to the state mandating participation. In preparation for mandatory reporting, a plan was made to centralize reporting to reduce the burden at the community hospitals and utilize the expertise that had been obtained from three years of reporting at the larger facility.


AABB:   How has your experience been using CDC’s National Healthcare Safety Network (NHSN) Hemovigilance Module?
LOH:      The module was easy to use until the upgrade in January 2017 that added many additional mandatory fields, many of which were later made optional.


AABB:   How have NHSN’s recent updates effect your reporting? Was there additional training that needed to be done? 
LOH:      There was a learning curve associated with the recent upgrade, but the additional information was retrievable in either our transfusion reaction final report or in the patient’s electronic medical record.


AABB:   How useful has reporting been?
LOH:      The NHSN reporting has allowed us to see that we are not the only hospital with a focus on transfusion reaction recognition and reporting. The Safe Table data analysis has also allowed us to do some benchmarking that we were unable to do previously.


AABB:   How has your experience been since joining the AABB Center for Patient Safety? How has participation helped improve your facility’s quality of care?
LOH:      The Patient Safety Organization Safe Tables have been particularly informative. Analyzed data is shared, participants can ask questions, Case Studies are presented, and relevant topics are addressed by experts.


AABB:   How have the resources provided by the AABB Center for Patient Safety helped your facility (i.e. webinars, safe tables, benchmark reports)? 
LOH:      Webinars are very valuable to staff members who don’t get the opportunity to spend the day away at a conference. The variety of topics has been much appreciated by a facility that has multiple aspects to its transfusion medicine service. Our manager was particularly interested in platelet wastage benchmarks along with patient safety.


AABB:   What has been your overall experience with hemovigilance as a whole?
LOH:      Hemovigilance is a unique and emerging subsection of the discipline of transfusion medicine and I am grateful to have been an early participant.


AABB:   How would you encourage and help new champions interested in advocating for the hemovigilance program at their facility?
LOH:      All the tools you need to get started are right on the CDC web site, with many self-tutorial materials that can guide you through the process. I would also mention the frequent webinars and other training sessions that are offered to help new participants. I attended a training session at the CDC and we even hosted a training session at our hospital.

AABB Center for Patient Safety Networking Events

AABB Center for Patient Safety (CPS) hosted two networking events during the 2017 AABB Annual Meeting: a networking reception for CPS members was held on Friday, October 6, and a Hemovigilance Champion Luncheon was held on Monday, October 9. Both events highlighted AABB’s efforts to increase reporting, awareness and the value of hemovigilance to participating members.

The AABB CPS Networking Event, offered exclusively to CPS members, generated robust discussions on interesting case study topics, new benchmark and comparison ideas, and upcoming collaborations with other patient safety organizations.2017AABB.png Certificates of appreciation were distributed to recognize members for their data contribution over the year. The event was an opportunity to share ideas and highlighted important projects such as the Transfusion-Associated Circulatory Overload (TACO) Reporting Criteria (2017) Validation Study.

The Hemovigilance Champion Luncheon gathered experienced members of the AABB CPS as well as interested hospitals and groups to discuss promotion of hemovigilance and the AABB CPS. Hemovigilance Champions have been instrumental in guiding new hospitals to join the CDC NHSN Hemovigilance Module and the AABB CPS, and have helped to expand participation within additional hospital systems. Attendees shared ideas about how the AABB CPS can further support the hemovigilance needs of participating hospitals, as well as provide additional support and guidance to prospective members. If you are interested in becoming a Hemovigilance Champion, please email hemovigilance@aabb.org.

Deadline to Participate in Validation Study of New TACO Definition Extended to Dec. 15

AABB has extended the deadline to participate in a study validating the updated definition of and hemovigilance reporting criteria for transfusion associated circulatory overload (TACO) to Dec. 15. This collaborative study among AABB, the International Society of Blood Transfusion (ISBT) and the International Haemovigilance Network (IHN) asks participants to assess 24 case reports appearing in randomized order TACOpin(1).PNGutilizing the proposed draft criteria for TACO and current ISBT definitions for other adverse transfusion reactions. The survey results will provide a synopsis on the effectiveness and accuracy of the definitions and the ability to distinguish between TACO and other acute pulmonary reactions.

Those who complete the survey will receive a downloadable report of their submission for future reference and will be acknowledged in any presentations arising from this work. In addition, the collaborators intend to submit a manuscript for publication based on the activity. Members can contact hemovigilance@aabb.org with any questions.

AABB Seeks Comments on Common Transfusion Reaction Reporting Form

AABB is seeking member comments on the AABB Common Transfusion Reaction Reporting Form intended for use by hospitals and blood centers to communicate information about transfusion reactions to the blood supplier, particularly when there are multiple suppliers to the hospital transfusion service. The form is intended to streamline the process for hospitals and provide complete information for blood suppliers when investigating transfusion reactions. The AABB PSO Advisory Committee developed the form through a collaboration with the Donor Hemovigilance Working Group.

The form is available for comment through Dec. 31. Members should send comments to hemovigilance@aabb.org with subject line “Common Transfusion Reaction Reporting Form” by Sunday, Dec. 31.

AABB to Upgrade West Nile Virus Biovigilance Network

AABB will upgrade the West Nile Virus (WNV) Biovigilance Network with new software to enhance the network's data collection and reporting processes. To facilitate this upgrade, the association will shut the network down temporarily. AABB will notify those with active WNV user accounts directly of the timing and will post status updates on the West Nile Virus Biovigilance Network page. Please contact the research department at hemovigilance@aabb.org or 301-215-6588 with any questions.

Hemovigilance Workshop Highlights Hemovigilance Developments and How Hospitals Participate

For both hemovigilance veterans and those considering participation in a hemovigilance program for the first time, the Hemovigilance Pre-Conference Workshop at the 2017 AABB Annual Meeting provided a crash course in several areas of hemovigilance.  

This sold-out program provided attendees with a comprehensive view of hemovigilance in the U.S. and highlighted areas of importance to organizations with established hemovigilance programs as well as those interested in initiating such a program. Speakers discussed regulatory requirements from the FDA, the FDA Hemovigilance system, the voluntary CDC National Healthcare Safety Network (NHSN) Hemovigilance Module and the AABB Center for Patient Safety.

Audience members also learned how to adopt a hemovigilance program at their hospital from W. Tait Stevens, MD, who recently initiated a program at Loma Linda University Medical Center in Loma Linda, Calif. Stevens walked attendees through each step of the enrollment process, including the hemovigilance enrollment form, the Patient Safety Organization agreement’s legal process, as well as how to gain access to the NHSN. 

Discussion also included the benefits to both patients and facilities through hemovigilance programs, including the ability to benchmark with other organizations and national averages, risk mitigation and gaining a better understanding of rare, serious adverse reactions through national data aggregation.

Additional information about AABB Hemovigilance is available online.

TRALI, TACO or None of the Above?

The hemovigilance experts — John Roback, MD, PhD; Pierre Robillard, MD; Mark Fung, MD, PhD; Kamille West, MD; and AABB Senior Director of Research Barbee Whitaker, PhD — were back to challenge attendees at the 2017 AABB Annual Meeting to identify and code adverse transfusion reactions based on CDC National Healthcare Safety Network (NHSN) Hemovigilance Module definitions, which were provided.

Presented with case studies, audience members answered multiple-choice questions on whether the cases represented transfusion reactions and, if so, which type. The audience was also asked what additional info would help them make that determination, how well each determination matched the CDC case definition, the severity of the reaction and the reaction's imputability — or to what degree the transfusion may have caused the reaction. Finally, audience members were asked whether they would keep the donors in the donor pool when a transfusion reaction was reported on a product that they donated.

For each case, the audience was given a patient’s background information, including any preexisting conditions and the event that led to the transfusion. Stump.jpg

The first case involved a 35-year-old male patient with leukemia who was admitted for acute abdominal pain and fever. He received a trans-jugular hepatic biopsy; the next day, he experienced dyspnea and tachypnea. A chest x-ray showed major bilateral pleural effusion, though his EKG was normal. Later that day, he went into hemorrhagic shock and received one cryo pool, three units of RBCs, four units of plasma and two units of apheresis platelets. Following the transfusion, the patient experienced progressive respiratory failure and was treated with oxygen. He had no fever his blood pressure was normal. A second chest x-ray showed significant deterioration of pleural effusions since the previous day’s x-ray, as well as new bilateral multifocal opacities. The intensivist did not report signs of circulatory overload and the patient was not intubated. The next day, a third chest x-ray showed improvement in bilateral diffuse infiltrates and a few days later, the patient’s lungs had cleared.

For this case study, most respondents chose “Possible TRALI” as the reaction and said that additional information on donors would have been helpful in coding the reaction. After learning that all the donors were either male or females with no history of pregnancy, many audience members changed their response to “Transfusion Associated Dyspnea.” Most participants the reaction as “severe” and the imputability “possible.” A large majority reported that they would keep the donors in the regular donor pool.

Although there were clear majorities for most of the answers, there was never an answer that garnered 100% of the votes.

Coding transfusion reactions can be a tricky proposition, but practice makes perfect. Case studies are regularly reviewed as part of AABB Center for Patient Safety Safe Table Calls.

Hemovigilance Module Updates

NEW Release Management Page

Starting this winter, the NHSN website will feature a new Release Management webpage. The overall purpose of this page is to provide visibility and transparency to the NHSN application development process, including defects resolution. CDC intends for the page to serve as an informational resource for both internal and external users. The page will list high impact defects and include a spreadsheet at the bottom containing all the defects currently in production, along with their status. CDC plans to update the page bi-weekly to ensure it reflects the most up-to-date and accurate information.

NEW User Support System

NHSN is implementing a new user support system to streamline the NHSN support email and allow users to interface with NHSN support staff more effectively. More information will be provided later.

Upcoming Training Modules

In December, CDC will add two new trainings on the NHSN Blood Safety Surveillance website under the Training tab. The first, a self-paced web-based training course, will address how to use the Hemovigilance Module’s Analysis feature. This training module describes the type of reports available in the Analysis feature and how individuals can use them to view, check and analyze data reported by their facility. Continuing education credit is available to those who complete the training. The second training module, a new Quick Learn on the automatic assignment of designations for case definition, severity and imputability, will be available to teach users how this new feature works and its benefits.

Upcoming Module Modifications

On January 1, CDC will make modifications to the Hemovigilance Module available to users. These modifications include the automatic assignment of designations for case definition, severity and imputability, and space for users to select their own designations. Additionally, CDC will add run charts to the Analysis feature. The agency made other minor modifications in response to user feedback, that include adding response options to certain questions and making other questions optional. Prior to release, these modifications were tested by Hemovigilance Module users. CDC will send additional information about all modifications to users closer to their release.

Case Study

A 25-year-old woman came to the emergency department with persistent chest pain on March 5. She had a history of severe restrictive lung disease, myelomeningocele and ESRD secondary to neurogenic bladder treated with hemodialysis three times a week. She was admitted to the inpatient floor. Blood was drawn and sent for routine testing on March 6; the results indicated an O-positive blood type and indicationscase.png of continued anemia. Hemoglobin was 8.2 g/dl upon admission and decreased to 6.6 g/dl. Her ABSC was negative. The patient received two units of electronic cross-matched O-positive blood without incident the next day. Two subsequent samples were sent to the Blood Bank for type and screen on March 13and March 30. Both showed negative ABSC results. A third sample was received on April 5 and showed a positive ABSC. This sample was worked up and an Anti-E was identified. The patient did not receive any other transfusions between March 7 and April 5.

Facility Coding:

Adverse Reaction: Other (originally categorized as Delayed Serologic Transfusion Reaction)

Case Definition: NA (originally categorized as Definitive)

Severity: Unknown/Not Stated (originally classified as Non-Severe)

Imputability: Definitive (originally categorized as needing further review)


The reaction met the specifications for case definition, but severity and imputability required additional follow-up. In order to classify a reaction as a DSTR, the severity must be “Not Determined,” since other categorizations do not fit the protocol. Imputability requires categorizations to fit the protocol, but there were cases in which wording for multiple designations were found. In these cases, the CDC NHSN advised to choose the lesser imputability (i.e., if wording exist for both definitive and possible, the imputability chosen should be possible). In this particular case, a new antibody was identified, but not within the time frame stated as “between 24 hours and 28 days.” With guidance from CDC NHSN, it was suggested to classify like reactions as “Other,” while capturing lab testing data, severity, imputability information specific to that case, and utilizing the comment section to explain why the reaction did not meet protocol and must be reported as ”Other.”
Publications of Interest

Amrein, K., Macher, S., Schröck, M., Schlenke, P. and Drexler, C. (2017), Iron deficiency in blood donors: perceptions and management among general practitioners and internists. Transfusion, 57: 2548–2549. doi:10.1111/trf.14297

Chadebech, P., Bodivit, G., Razazi, K., de Vassoigne, C., Pellé, L., Burin-des-Roziers, N., Bocquet, T., Bierling, P., Djoudi, R., Mekontso-Dessap, A. and Pirenne, F. (2017), Red blood cells for transfusion in patients with sepsis: respective roles of unit age and exposure to recipient plasma. Transfusion, 57: 1898–1904. doi:10.1111/trf.14170

Chaffin, Joe (Producer). (2017, November 27). 041: Blood Donor Questions with Mary Townsend [Audio Podcast]. Retrieved from http://www.bbguy.org/

Cid, J. (2017), Prevention of transfusion-associated graft-versus-host disease with pathogen-reduced platelets with amotosalen and ultraviolet A light: a review. Vox Sang, 112: 607–613. doi:10.1111/vox.12558

Germain, M., Delage, G., O'Brien, S. F., Grégoire, Y., Fearon, M. and Devine, D. (2017), Mitigation of the threat posed to transfusion by donors traveling to Zika-affected areas: a Canadian risk-based approach. Transfusion, 57: 2463–2468. doi:10.1111/trf.14247

Goldman, M., Steele, W. R., Di Angelantonio, E., van den Hurk, K., Vassallo, R. R., Germain, M., O'Brien, S. F. and Biomedical Excellence for Safer Transfusion Collaborative (BEST) Investigators (2017), Comparison of donor and general population demographics over time: a BEST Collaborative group study. Transfusion, 57: 2469–2476. doi:10.1111/trf.14307

Juffermans, N. P. and Vlaar, A. P. (2017), Possible TRALI is a real entity. Transfusion, 57: 2539–2541. doi:10.1111/trf.14236

Otrock, Z. K., Liu, C. and Grossman, B. J. (2017), Transfusion-related acute lung injury risk mitigation: an update. Vox Sang, 112: 694–703. doi:10.1111/vox.12573

Tomasulo, P. A. and Jacobs, M. R. (2017), The negative secondary test for bacterial contamination: reducing the risk of septic transfusion reactions from platelets. Transfusion, 57: 2054–2055. doi:10.1111/trf.14221

Vossoughi, S., Perez, G., Whitaker, B. I., Fung, M. K. and Stotler, B. (2017), Analysis of pediatric adverse reactions to transfusions. Transfusion. doi:10.1111/trf.14359

Wong, W. S., Wong, K. F., Kwok, J., Tsoi, W. C. and Leung, J. N.-s. (2017), A life-threatening transfusion reaction. Transfusion, 57: 2076. doi:10.1111/trf.14051