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Hemovigilance Update - Summer 2017

Hemovigilance Updates
SUMMER 2017
IN THIS ISSUE
  • AABB Center for Patient Safety: Safe Table Meeting: Tuesday, Sept. 19, 2017 at 2:00 pm.
  • North Carolina Association of Blood Bankers (NCABB) Annual Fall Meeting: Sept. 10-12, 2017 in Charlotte, N.C.
  • Wisconsin Association of Blood Banks (WABB) Meeting, Sept. 12-13, 2017 in Appleton, Wis.
  • AABB Center for Patient Safety: Safe Table Networking Event: Friday, Oct. 6, 2017 at 5:00 pm in San Diego, C.A. (Invitation Only)
  • AABB Hemovigilance Champion Luncheon: Monday, Oct. 9, 2017 at 12 pm in San Diego, C.A. (Invitation Only)
  • Blood Bank Association of New York State (BBANYS) fall webinar topic: Hemovigilance on Tuesday, Oct. 17, 2017 at 1 pm.

The overall transfusion reaction rate may be twice as high among pediatric patients compared with adults, according to new findings presented recently at the 27th Regional Conference of the International Society for Blood Transfusion, held in June in Copenhagen.

 

The study, conducted by Sarah Vossoughi, MD; Gabriela Perez, MS; Barbee Whitaker, PhD; Mark Fung, MD, PhD; and Brie Stotler, MD, MPH, retrospectively compared reaction rates by age group and blood products. The researchers used hemovigilance data to characterize differences in adverse transfusion responses between pediatric and adult patients. Transfusion reaction data were obtained from the AABB Center for Patient Safety participants and from Children’s Hospital of New York. Pediatric patients had significantly higher rates of allergic and febrile non-hemolytic transfusion reactions; higher reaction rates were observed for transfusions of red blood cells and platelets. Adult patients had higher rates of all types of delayed reactions and transfusion-associated circulatory overload (TACO). The researchers said the findings highlight the need for additional data to understand and determine best practices for pediatric blood transfusions.

A 75-year-old male patient was transfused in an outpatient setting with two units of red blood cells (RBCs) as treatment for chemotherapy-induced pancytopenia. His underlying condition was acute myeloid leukemia. He was immune compromised and transfusion-dependent. The patient’s blood group was A+; both units of transfused blood were group A-. The transfusions ended at 19:40 and 23:20 respectively. The patient was discharged to home following the completion of the second transfusion.
 
The next morning, the patient’s family noticed he was short of breath, had a fever and was coughing. Family members took him to the emergency department at a nearby outlying hospital at 11:00. Although the exact time of onset of the patient’s symptoms was not known, it was estimated to have occurred between 6-12 hours post-transfusion. At presentation in the emergency department, the patient was febrile with a temperature of 104.1° F. Febrile neutropenia was suspected. The patient also exhibited dyspnea and hypoxia with an O2 saturation level of 92%, a peak respiratory rate of 23 breaths per minute and bilateral fine crackles were heard on lung auscultation.
 
No pre-transfusion chest x-ray was taken, but a post-transfusion chest x-ray showed bilateral diffuse pulmonary infiltrates. No risk factors for acute lung injury prior to hemotherapy were identified. The patient’s treatment included antibiotics, diuretics, oxygen supplementation and transfer to a higher acuity care level facility. Due to the proximity of the earlier transfusions to his clinical presentation in the emergency department, the blood bank was notified of a suspected transfusion reaction.
 
Blood Bank investigations indicated no evidence of a hemolytic transfusion reaction, but rises in the patient's NT-ProBNP levels were noted. Prior to transfusion, the patient’s NT- ProBNP level was 291 pg/ml compared with 932 pg/ml about 12 hours after transfusion; the NT -ProBNP level increased to 1,697 pg/ml at 35 hours post-hemotherapy (normal range <125 pg/ml). The patient had no reported history of congestive heart failure. Volume overload was suspected as a contributory cause of the reaction and neutropenic fever as the etiology of the patient's febrile feature associated with the reaction.
 
Hospital Coding
Reaction: TACO, Definitive
Grade: Severe
Imputability: Definite
 
Further Commentary:
Although the patient presented with 3 (respiratory distress, elevated NT-ProBNP level, and radiographic evidence of pulmonary edema) of the 6 requirements for TACO, the exact timing of the reaction occurrence is unknown. Nevertheless, with such a presentation, it is reasonable to assume that the case is indeed TACO. In this regard, it is interesting to note the proposed revisions to the International Society of Blood Transfusion's (ISBT) surveillance case definition of TACO, one of which extends the time frame beyond the current 6 hour interval to 12 hours post-transfusion.
 
The patient was hospitalized after presenting to the emergency department and medical intervention was required, hence the grade of “Severe” was assigned.
 
Imputability status was determined to be “Definite” since there were no other fluids given to the patient prior to the hemotherapy in the outpatient setting and he had no history of cardiac insufficiency.
New hepatitis C virus (HCV) infections have reached a 15-year high, tripling between 2010 and 2015, according to new preliminary surveillance data from the Centers for Disease Control and Prevention. The agency noted that while the reported number of new cases reached 2,436 in 2015, the true number was estimated to be much higher — approximately 34,000 — given the high proportion of asymptomatic infections. Not only is the overall number of new cases on the rise, but infections are increasing most rapidly among young people. Patients aged 20-29 years accounted for the highest number of new infections. Officials from the CDC said that “this is primarily a result of increasing injection drug use associated with America’s growing opioid epidemic.”
A new study designed to validate the revised definitions for transfusion-associated circulatory overload (TACO) began in May. The revised definition of TACO was developed following the 2013 meeting of the International Society of Blood Transfusion’s Haemovigilance Working Party, held in Amsterdam. An update was recommended due to concerns that a strict application of the previous (i.e. current) definition could “lead to non-acceptance of cases, which would otherwise be identified as TACO by clinicians and by some hemovigilance systems.”
 
The goal of the validation study is to “assess if the proposed revisions to the definition will distinguish between TACO and other acute pulmonary reactions, identify true TACO cases, and evaluate whether the revised definition will adequately define/classify clinical cases that were reported to national hemovigilance systems as TACO and accepted as TACO according to each system’s evaluation procedures.”
 

The validation study will be conducted in two phases. In the first phase, representatives of hemovigilance systems worldwide are selecting cases from their hemovigilance databases and classifying them according to the revised TACO criteria using a checklist. The second phase, which will begin later this year, will involve classifying a set of case descriptions and will be open to individual hemovigilance professionals in any country.

Zika virus (ZIKV) can be transmitted by infected female Aedes aegypti and Aedes albopictus mosquitoes to their offspring — a process known as vertical transmission — according to new data published in “Emerging Infectious Diseases.” The findings indicate that this type of transmission could be a factor in the spread and persistence of ZIKV. Researchers studied the presence of ZIKV in the offspring of infected female mosquitoes using ZIKV-specific quantitative reverse transcription PCR, to determine not only infection in adult mosquitoes but also viral load and rate of infection of progeny. “These results indicate that Zika virus has a relatively high capacity for being transmitted vertically by both A. aegypti and A. albopictus mosquitoes,” the researchers concluded.
 
The researchers noted that the pattern of vertical transmission observed in ZIKV was similar to that previously seen in West Nile virus. They added that previous studies have demonstrated that vertical transmission is “generally relatively inefficient” for other flaviviruses, including dengue, yellow fever and St. Louis encephalitis.

AABB will host the annual "Introduction to Hemovigilance" preconference workshop on Friday, Oct. 6, from 1:30 pm to 5:00 pm before the 2017 AABB Annual Meeting in San Diego, Calif. The workshop will provide a comprehensive view of hemovigilance in the United States, including updates from the FDA, the CDC National Healthcare Safety Network Hemovigilance Module, the AABB Center for Patient Safety and findings from donor and recipient hemovigilance programs. A panel of industry experts will discuss hemovigilance activities in the United States, international efforts to harmonize hemovigilance definitions and advantages to participation in recipient and donor hemovigilance programs. The panel will also highlight findings from recent hemovigilance studies and identify sub-populations that are at increased risk. Speakers include Barbee Whitaker, PhD; Mary Gustafson; Wesley Stevens; and Joy Fridey.

 

AABB also announces the return of the “Stump the Hemovigilance Experts” session at this year’s Annual Meeting. This audience participation event provides the opportunity to participate in the analysis and coding of transfusion reactions using the national definitions used by the CDC National Healthcare Safety Network - Hemovigilance Module. Attendees are encouraged to bring or submit cases from their own experiences – no matter how simple or complex – and discuss categorization with the experts. This session will be hosted by Barbee Whitaker, PhD. The panel of experts will include John Roback; Pierre Robillard, MD; Mark Fung, MD, PhD; and Kamille West, MD.

 

Other sessions of hemovigilance interest at the 2017 AABB Annual Meeting:

Below is a step-by-step guide to indicate that your hospital does not have any adverse reactions or incidents to report for a specific month.

Each organization must complete the Monthly Reporting Plan for any month in which reporting is to occur. If this plan isn’t created, you cannot enter data into NHSN for that specific month.

[You may create your Monthly Reporting Plans for the entire year at one time, thereby saving yourself remembering each month.]
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The Monthly Reporting Plan is used by CDC to track the number of facilities actively reporting to the Hemovigilance Module. The Monthly Reporting Plan asks facilities to indicate if they are either participating or not participating in hemovigilance surveillance for the particular month.

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If your facility is NOT PARTICIPATING, then you need do nothing else to indicate that you do not have any adverse reactions or incidents to report.

“Participating” facilities should then proceed to complete the Monthly Reporting Denominators form, which is used by CDC for national analysis to calculate rates. 

On this form, hospitals should indicate when there are no adverse reactions or incidents to report. See the red arrows below pointing to where you should check if you have no adverse reactions or no incidents to report for a given month.

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You will still need to complete the denominator form with numbers of units transfused, since this is used to calculate overall rates.

These indications will be directly linked to the Alerts section of the Biovigilance Component. If no indication has been made on the denominator form whether there are no adverse reactions and/or incidents reported in the month, an alert can be observed for Missing Incidents, Missing Adverse Reactions, or Missing Denominator Forms. These indicate that you have completed the Monthly Plan showing that you intend to report results for the month and that you have not yet reported either that you have nothing to report or to report your incidents and adverse reactions. You can get more information by clicking on the Alert specifically and that will take you directly to the location of the missing data. If the facility later enters an adverse reaction, the original indication chosen, “No Adverse Reactions reported this month” will be overridden and will no longer be active.

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For example, in May 2017, a Monthly Reporting Plan was created, which indicated the facility would participate in hemovigilance surveillance. The facility completed the Monthly Reporting Denominators form and indicated “No Adverse Reactions reported this month.”  There will be no “Missing Adverse Reactions” Alert for May 2017. If the facility did not choose “No Adverse Reactions reported this month,” there will be an alert for “Missing Adverse Reaction” for May 2017. If the facility has an adverse reaction to report after checking the box, the report can be entered and saved as usual. The adverse reaction entry will override the “No Adverse Reactions reported this month” that was previously indicated on the Monthly Reporting Denominator form.

France, C. R., France, J. L., Himawan, L. K., Kessler, D. A., Rebosa, M. and Shaz, B. H. (2017), Donating blood on a regular basis appears to reduce blood pressure, but appearances can be deceiving. Transfusion, 57: 933–937. doi:10.1111/trf.13975

Tomasulo, P. A. (2017), Reducing the risk of septic transfusion reactions from platelets. EDITORIAL, 57: 1099–1103. doi:10.1111/trf.14111

Greninger, A. L. and Hess, J. R. (2017), Clostridium perfringens sepsis masquerading as a hemolytic transfusion reaction. Transfusion, 57: 1112. doi:10.1111/trf.13863

Yazer, M. H., Lozano, M., Fung, M., Kutner, J., Murphy, M. F., Oveland Apelseth, T., Poglód, R., Selleng, K., Tinmouth, A., Wendel, S., Yahalom, V. and on behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative (2017), An international survey on the role of the hospital transfusion committee. Transfusion, 57: 1280–1287. doi:10.1111/trf.14033

Loza-Correa, M., Kou, Y., Taha, M., Kalab, M., Ronholm, J., Schlievert, P. M., Cahill, M. P., Skeate, R., Cserti-Gazdewich, C. and Ramirez-Arcos, S. (2017), Septic transfusion case caused by a platelet pool with visible clotting due to contamination with Staphylococcus aureus. Transfusion, 57: 1299–1303. doi:10.1111/trf.14049

Lin, Y. and Haspel, R. L. (2017), Transfusion medicine education for non-transfusion medicine physicians: a structured review. Vox Sang, 112: 97–104. doi:10.1111/vox.12499

Headley, M. (2017), Why are medical errors still a leading cause of death? PSQH: Patient Safety and Quality Healthcare, 14(2), 12-18.

Headley, M. (2017), Nurses drive change in patient safety improvements. PSQH: Patient Safety and Quality Healthcare, 14(2), 26-28.

Peters, A. L., Van De Weerdt, E. K., Goudswaard, E. J, Binnekade, J. M., Zwaginga, J.J., Beckers, E. A. M., Zeerleder, S. S., Van Kraaij, M. G. J., Juffermans, N.P., Vlaar, A. P. J. (2017), Reporting transfusion-related acute lung injury by clinical and preclinical disciplines. Blood Transfusion. DOI: 10.2450/2017.0266-16

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