Risks Associated with Transfusion

While blood transfusion is, in many respects, safer than it has ever been, the risks associated with transfusion are still present and must be evaluated against the benefit provided by transfusion. The following information has been compiled to provide both current infectious risks and non-infectious risks of blood transfusion. References to support this information are given at the bottom.

Adverse Transfusion Reactions

A transfusion should be stopped immediately whenever a transfusion reaction is suspected, and an investigation should be performed according to institution procedures. Should there be an issue, where after investigation, the reaction needs to be reported to Vitalant due to an attribute specific to the donor or the processing of the blood product (e.g., potential bacterial contamination of the component), report the information using the AABB Report of Adverse Reaction Form (PDF). The tables below list symptoms associated with types of reactions.

If an Adverse Reaction Occurs

We need your help to report promptly any reactions that may be due to an attribute specific to the donor or processing of the blood or blood components. Examples of such adverse events include:​

• Sepsis (due to bacterial contamination of blood components)
• TRALI (due to HLA antibodies in donated blood)
• Infection (due to window-period infections or pathogens for which there are no tests)

In all cases, timely reporting is vital so that we may prevent the transfusion of other components from the same donor(s) or donation(s), if needed. You will report recipient adverse events to us and any other blood supplier who may provide blood or blood components to your facility using the Transfusion Adverse Reaction Form (PDF).

Please note that for transfusion-associated infections other than septic bacterial reactions, you will need to continue to use Form BS 314 (PDF).

Hemovigilance

Understanding the incidence of adverse reactions associated with transfusion is essential to continuously improve the safety of the blood supply. Our goal is aligned with yours. We want to provide patients with the products they need when they need it and with the desired outcome. Our investigations into adverse patient reactions allow us to evaluate and follow up with donors, as appropriate, to determine their future eligibility as a community blood donor. Additionally, components made from the blood of implicated donors may need to be quarantined and other recipients may need to be notified.

In order to expedite our investigation, we ask that you please provide complete clinical information; it is essential to our evaluation. You can find all the forms you need on our website. Frequently asked questions are included on the new AABB form.

Vitalant has information regarding transfusion-associated risks including the incidence of some transfusion adverse reactions based on active surveillance studies and incidence of residual risk for transfusion transmitted infections based on current screening practices. We hope that you consider these statistics as a benchmark for your institution. Case definitions of transfusion adverse reactions are described in the CDC’s National Healthcare Safety Network Biovigilance Component Hemovigilance Module Surveillance Protocol.

NOTE: The Code of Federal Regulations, Title 21, Section 606.170, and the AABB Standards for Blood Banks and Transfusion Services, Standard 7.5, address the requirements for the recognition, evaluation, and reporting of suspected adverse events in recipients related to the transfusion of blood components and to the use of tissue or derivatives supplied by all blood collection agencies and blood product manufacturers.

If you have any questions or comments, please call 1-800-811-2581.

Immediate Transfusion Reactions

Delayed Transfusion Reactions

Additional Information Relating to Transfusion Related Acute Lung Injury (TRALI)

TRALI is a syndrome characterized by bilateral pulmonary edema, hypoxia, tachycardia, fever, hypotension and cyanosis in the setting of transfusion of plasma containing blood components, always within 1-6 hours and usually within 2 hours. Normal central venous and pulmonary wedge pressures are consistent with TRALI.

TRALI is a diagnosis of exclusion. Other causes of respiratory distress and pulmonary edema in a transfusion setting such as myocardial infarction, circulatory overload or bacterial infection should be ruled out.

• Acute onset (During or within 6 hours of transfusion)
• Hypoxemia:
  • PaO2 /FiO2 ≤ 300,
  • Or SpO2 < 90% on room air
• Bilateral infiltrate on chest x-ray
• No left atrial hypertension (i.e., circulatory overload)

Suggested Laboratory Investigations

TRALI is a syndrome characterized by bilateral pulmonary edema, hypoxia, tachycardia, fever, hypotension and cyanosis in the setting of transfusion of plasma containing blood components, always within 1-6 hours and usually within 2 hours. Normal central venous and pulmonary wedge pressures are consistent with TRALI.

TRALI is a diagnosis of exclusion. Other causes of respiratory distress and pulmonary edema in a transfusion setting such as myocardial infarction, circulatory overload or bacterial infection should be ruled out.

• White blood cell count
• B-natriuretic peptides (BNP)
• Type for HLA Class I & Class II antigens
• Priming activity

• Priming activity

• Screen samples for HLA Class I & Class II antibodies. (If HLA antibody identified, type for specificity.)
• Screen donors for neutrophil antibodies. (If HNA antibody identified, type for specificity.)

• A crossmatch between donor serum a patient white blood cells

Transfusion Associated Infections

If a possible TAI is identified, complete a Report of Transfusion Associated Infection form (BS 314) and submit to your blood center. The center will forward the form to the Medical Affairs department at our national office for investigation and evaluation. A follow-up letter(s) is sent to the transfusion facility to allow the facility to notify the recipient’s attending physician of the results of the investigation.

The risk of acquiring an infectious disease through blood transfusion has not been totally eliminated even though the level and sensitivity of testing today makes transfusion very safe. Physicians/hospital staff should report all instances when an infectious disease is reasonably likely to have been transmitted by a blood transfusion.

The requirements for investigating Transfusion Associated Infections (TAI) are found in the Code of Federal Regulations, Title 21, Section 606.170, and the AABB Standards.

The most commonly investigated infectious diseases are: retroviruses, hepatitis viruses, West Nile virus, malaria, babesiosis and Chagas Disease.

• Complete medical history
• Clinical laboratory data
• History of known risk factors for the reported infection

• Quarantine of additional infectious components
• Deferral of an “unsafe” donor
• Notification of the donor and other recipients of the donor’s blood
• Process improvements

In January of each year, Vitalant sends the “Letter to Encourage Reporting of TAI” to transfusion facilities served by the center. It is the responsibility of the transfusion facility to have monitoring and identification mechanisms and policies in place to recognize potential TAI related to transfusion and to report them to the blood center.

A transfusion service should report to the blood center the recipient adverse reactions that may require blood center investigation if the hospital post-transfusion workup indicates possible bacterial contamination, transfusion-associated infectious disease or TRALI reaction. These steps assure that other products from the same donor(s) can be quickly withdrawn.

The Vitalant blood center Medical Director will evaluate each reported case and determine if it may be transfusion related and outline preliminary actions to be taken.

Recalls

A recall is indicated upon discovery of any discrepancy that could affect the safety, purity and/or potency of any product shipped from Vitalant. The depth of a recall may be determined based on the product's potential hazard to the recipient.

A market withdrawal is indicated when information on a donor with active products warrants further evaluation even though the products were not mislabeled or misbranded at the time of distribution. Examples may be post-donation history information or subsequent repeat reactive screening results.