Blood Transfusion Practices

Vitalant Blood Products

As the second largest blood services provider in the nation, Vitalant distributes a variety of blood components and products to our healthcare partners around the country for transfusion, including:

We also provide a variety of modified blood components and derivatives, described on the specialty blood products page of our website.

For information relating to indications and benefits of transfusion, refer to the Circular of Information (COI) for the Use of Blood and Blood Components. This brochure is produced jointly by the AABB, America’s Blood Centers and the American Red Cross. You can view the current version of the COI online.

storing blood
blood products

Red Blood Cells

Red blood cells, or erythrocytes, are continuously produced in our bone marrow to transport oxygen and nutrients to body tissues and remove carbon dioxide and waste.

They are the most transfused blood component, indicated for more than 70% of all transfusions. Patients who lose significant volumes of blood require red blood cell transfusions, including patients who have:

  • Suffered severe trauma resulting in acute blood loss
  • Chronic anemia resulting from kidney failure or gastrointestinal bleeding
  • Perforated bleeding ulcer
  • Major surgical procedure planned
  • Blood disorders such as sickle cell disease.

Red blood cells are prepared from whole blood by removing the plasma and have a shelf life of up to 42 days, depending on the type of anticoagulant used when they are stored. They can also be treated and frozen for 10 years or more.

Uses for Red Blood Cells

Red blood cells (RBCs) contain hemoglobin and serve as the primary agent to transport oxygen to body tissues. All RBC components and whole blood increase the patient’s capacity to carry oxygen by increasing the mass of circulating red cells. Components that contain RBCs are indicated for treatment of symptomatic or critical deficit of oxygen-carrying capacity, as well as for red cell exchange transfusion.

Compatible Red Blood Cell Components for Transfusion

The following table, defined by type of component, shows the appropriate donor unit ABO Group and Rh Type that will be compatible with the patient/recipient:

Red Blood Cells
Component Requested Recipient’s ABO Group Component ABO Group
Whole Blood O, A, B, AB ABO Identical
Red Blood Cells O O
  A A or O
  B B or O
  AB AB, A, B, or O

 

D Requirements
Recipient D Type  Red Cell Component D Type  Platelet Component D Type
D Positive  D Positive or Negative  D Positive or Negative 
D Negative  D Negative  O
  A D Negative Preferred 

Vitalant’s Red Cell Reference Laboratory

Vitalant’s Red Cell Reference Laboratory is an integral part of Vitalant Clinical Services. The lab performs both routine and complex serological problem resolutions and provides a wide variety of blood products. The Red Cell Reference Laboratory staff is also available at all times to provide technical consultation.

The Red Cell Reference Laboratories are accredited Immunohematology Reference Labs (IRL) by the AABB. As such, the labs have at their disposal a multitude of resources to aid in both serological problem resolution and provision of blood products. This includes an extensive inventory of rare cells and sera for use in complex serological problem resolutions. All labs have access to available local blood center inventory as well as inventory from all of Vitalant locations. In addition, all locations maintain an inventory of frozen rare units for use in unusual compatibility cases.

The Red Cell Reference Lab is also a member of the American Rare Donor Program (ARDP). In the event that the necessary product is not available at VBS, the lab can obtain the products from another Vitalant blood center or through a national network of blood centers.

Each type of blood component requires certain pre-transfusion testing and selection of the appropriate component, based on recipient and donor ABO/Rh determinations. All testing is completed in accordance with AABB and Food and Drug Administration (FDA) standards. Because of these standards, the Red Cell Reference Lab is not able to provide cross-matched blood products unless an ABO/Rh determination as well as complete antibody identification has been performed on the sample submitted. All staff are instructed to complete only necessary testing to resolve the serological problem, but required tests will vary with each sample submitted based on the nature of the serological problem.

If there are any concerns about the suitability or quality of a blood component received from your local blood center, please contact the center directly.

Blood products

Blood Filters

All blood products must be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient. There are a variety of filters available on the market. Your facility should have protocols in place for selecting filters, conditions for use and under what conditions any solution except 0.9% sodium chloride (USP) is used with the filter or added to the blood bag.

Blood Components Storage

Transfusion facilities must furnish specific storage units restricted to storage of blood and other biologicals that are capable of maintaining required storage temperatures, as stated in Vitalant’s Hospital Blood Services Agreement and specified in Title 21 of the Code of Federal Regulations, Standards of the AABB.

Temperature Monitoring of Approved Storage Units

Storage units approved for storage of blood or blood components at the facility must be equipped with a system that monitors continuously and records temperatures at least every 4 hours and with an alarm that sounds if temperature limits are reached.

The facility must notify Vitalant within 24 hours of any occurrence of temperature deficiencies in the storage of blood and blood components and agrees not to return units subjected to temperatures outside the required ranges, unless approved for return by Vitalant.

Documentation of storage temperatures may be required during inspections by regulatory agencies.

storing blood components

Requirements for Blood Storage Units

Requirements for Blood Storage Units
Component Storage Temperature
Whole Blood, Red Blood Cells 1-6C
Plasma, Cryoprecipitated AHF -18C or colder
Platelets 20-24C, with gentle agitation
Granulocytes 20-24C, without agitation

Additional Criteria for Storage and Handling

  • Blood component receipt temperature must be documented.
  • Blood and blood products must be stored in approved and labeled storage areas/units.
  • Store in an orderly fashion to prevent crowding and to allow air circulation.
  • Do not store quarantined components above other components.
  • Do not store reagents above blood components.
  • Do not overlap platelet bags during storage.
  • Store red cells to allow visual observation of hemolysis at the red cell interface.
  • Segregate autologous components from allogeneic components.
  • Vitalant boldly labels autologous components with positive test results as Biohazardous and may ship such units in special Biohazardous shipping containers. Biohazard-labeled autologous components should be kept segregated from other non-biohazardous autologous components.
  • When released to another department, blood components must be maintained within appropriate storage temperatures or returned to proper storage within a specified time if storage is not available and the component is not transfused.

Storage Unit Failures

In the event of a storage unit failure, components must be moved to appropriate alternative storage. If alternative storage is not available with a temperature monitoring system that alarms for out of range temperatures, contact Vitalant Hospital Services to discuss alternative storage at Vitalant, the use of Vitalant shipping containers as alternative storage or other suitable solutions.

Please contact your local blood supplier for proper packing instruction for alternative storage.

Risks Associated with Transfusion
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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.

Infectious Risks of Blood Transfusion, 2007 to 2012
Agent Risk Per Unit Transfused
Parvovirus B19 (erythrovirus) Unknown; about 12 cases reported in the literature
Babesia  1:20,000 
Bacteria (platelets)  1: 5,000 (tested)
Bacteria (RBCs)  1:500,000 
Hepatitis A virus  1:1 million 
Hepatitis B virus  1:850,000 to 1:2 million 
Hepatitis C virus  1:1,150,000 
HIV (Human Immunodeficiency virus)  1:2 million 
Human T-lymphotrophic virus  1:200,000 to 1:500,000 
Malaria 1:1,000,000 
West Nile virus  Unknown but varies by season; about 11 cases reported in the literature since 2003 
 
Non-infectious Risks of Blood Transfusion, 2007 to 2012
Adverse Outcome  Risk Per Unit Transfused  Clinical Signs & Symptoms 
Acute hemolytic  1:40,000 to 1:70,000  Chills, fever, pain at infusion site, hemoglobinuria, shock, acute renal failure, flank pain, DIC 
Allergic - simple 1:100 to 3:100  Flushing, hives, itching 
Allergic  - severe  1:20,000 to 1:50,000  Hypotension, respiratory distress, wheezing, local edema 
Transfusion associated circulatory overload (TACO)  1:100 to 11:100  Dyspnea, hypertension, pulmonary edema 
Delayed hemolytic  1:5,000 to 1:11,000  Drop in hemoglobin, increased indirect bilirubin, new RBC antibodies 
Febrile non-hemolytic 1:100 (prestorage leukoreduced products)  Fever with greater than 1°C change, chills, rigors 
Graft versus host disease  Rare  Rash, diarrhea, hepatitis, pancytopenia 
Transfusion-related acute lung injury (TRALI) 8:100,000  Hypoxemia, dyspnea, hypotension, non-cardiogenic pulmonary edema
Adverse Transfusion Reactions
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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
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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
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Immediate Transfusion Reactions

Immediate Transfusion Reactions
Type of Reaction Definition Symptoms
Transfusion associated sepsis Bacterial contamination of transfused blood
  • Shaking chills
  • Hemoglobinuria
  • DIC
  • Oliguria/anuria
  • Fever over 39C (or 102F), or rise of 2C or 3.5F over pretransfusion values
  • Heart rate 120/min, or rise of 40/min from pretransfusion values
  • Drop or rise in blood pressure of 30/mm Hg over pretransfusion values
Febrile non-hemolytic reactions Temperature increase of >1C associated with transfusion and without any other explanation
  • Temperature increase ≥ 1C or 2F
  • Chills
  • Rigors
Immune-mediated hemolysis Transfused RBCs interact with pre-formed antibodies in recipient
  • Fever, (rise of ≥1C or 2F)
  • Chills
  • Pain in chest, lower back, abdomen, and/or at infusion site
  • Hypotension (decrease by ≥ 20 mmHg)
  • Nausea
  • Flushing
  • Dyspnea
  • Hemoglobinemia
  • Hemoglobinuria
  • Bilirubinemia/Billirubinuria
  • Oliguria/Anuria
  • Acute pancreatitis
  • Shock
  • Generalized bleeding (DIC)
Non immune-mediated hemolysis

Red cells undergo hemolysis due to:

1. Temperature related damage due to
  • Improper storage or shipping temperatures
  • Malfunctioning or improper use of blood warmers (use of microwave ovens or hot water baths)
2. Mechanical hemolysis due to oller pumps, pressure infusion pumps, pressure cuffs
3. Addition of drugs or hypotonic solutions to blood component or IV solutions
May present with symptoms similar to immune-mediated hemolysis
Urticaria (Hives) Mid allergic reaction to transfusion
  • Generalized rash, erythematous macular eruption
  • Hives
  • Itching
  • Usually without fever
Anaphylactic reactions (occur after infusion of only a few mL of blood component) Severe allergic reaction to transfusion in which there are systemic symptoms
  • Coughing, bronchospasm, respiratory distress
  • Vascular instability, hypotension
  • Nausea, abdominal cramps, vomiting
  • Diarrhea
  • Shock
Air Embolism Air allowed into infusion equipment or blood in open system infused under pressure causing air bubble
  • Cough
  • Dyspnea
  • Chest pain
  • Shock
Transfusion-related acute lung injury (TRALI) A new episode of acute lung injury (ALI) that occurs during or within 6 hours of a completed transfusion
  • Acute respiratory insufficiency in the absence of evidence of circulatory overload
  • No left atrial hypertension
  • Acute onset
  • Hypoxemia (capillary oxygen decreases to <90% on room air)
  • Bilateral infiltrates on frontal chest x-ray
  • No other evidence of cardiac failure or a cause for respiratory failure
Transfusion Associated Circulatory Overload (TACO) Acute pulmonary edema due to volume overload
  • Dyspnea, orthopnea
  • Severe headache
  • Hypertension, tachycardia
  • Congestive heart failure
  • Acute pulmonary edema
Metabolic reactions Metabolic derangements resulting from large-volume transfusions
  • Citrate toxicity
  • Hyperkalemia
  • Hypocalcimia
  • Hypothermia
  • Respiratory alkalosis
Hypothermia Depressed body temperature resulting from rapid infusion of large volumes of cold blood components
  • Hypothermia
  • Cardiac arrhythmia or arrest
  • Exacerbation of underlying coagulopathy
Delayed Transfusion Reactions
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Delayed Transfusion Reactions

Delayed Transfusion Reactions
Type of Reaction Definition Symptoms
Alloimmunization to red cell antigens (usually an anamnestic immune response that occurs from 3-10 days post-transfusion)
Risk: 1-1.6% per donor unit
Development of newly formed antibodies to red cell antigens
  • Fever
  • Decreasing hemoglobin
  • Mild jaundice
  • Signs of hemolysis in about 20-35% of sensitized recipients
Alloimmunization to leukocyte antigens
Occurs in patients receiving repeated platelet transfusions and women with > 4 pregnancies
Development of antibodies to leukocyte (HLA) antigens Signs of febrile non-hemolytic transfusion reactions
Refractoriness to platelet transfusion Rapid clearance of transfused platelets due to HLA sensitization or other clinical factors Poor incremental increase in platelet count after a suitable dose of platelets
Post-transfusion purpura (usually occurs > 1 week after transfusion) Abrupt onset of severe thrombocytopenia an average of 9 days post transfusion (range 1-24 days)
  • Precipitous fall in platelet count
  • Generalized purpura
Iron overload
Occurs in chronically transfused patients (> 20 units per lifetime)
Accumulation of iron and no physiologic means of excretion
  • Interference with heart, liver or endocrine gland function
  • Hepatic failure
  • Cardiac toxicity
Acute Transfusion-associated Graft-vs-Host disease Immunologic complication caused by engraftment and proliferation of donor lymphocytes in a susceptible host
  • Fever
  • Erythroderma, often starting on palms, soles, earlobes, and face, ranging from edema to full blistering
  • Enterocolitis
Additional Information Relating to Transfusion Related Acute Lung & Injury (TRALI)
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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.

ALI:
  • 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)
No preexisting ALI
No temporal relationship to an alternate risk factor for ALI
Suggested Laboratory Investigations
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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.

Patient:
  • White blood cell count
  • B-natriuretic peptides (BNP)
  • Type for HLA Class I & Class II antigens
  • Priming activity
Blood component:
  • Priming activity
Donors (Done on all donors or on a sequential testing algorithm):
  • 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.)
Patient/Donor(s):
  • A crossmatch between donor serum a patient white blood cells
Transfusion Associated Infections
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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.

The hospital’s investigation includes:
  • Complete medical history
  • Clinical laboratory data
  • History of known risk factors for the reported infection
The objectives of blood center investigations of TAI are:
  • 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
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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.

Quick links for ordering blood products from Vitalant

References

  • Busch MP, et al. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion. 2005;45:254-264.
  • Carson JL, et al. Red blood cell transfusion: A clinical practice guideline from the AABB. Ann Int Med. 2012;157:49-58.
  • Cullen KA, et al. Malaria surveillance – United States, 2011. MMWR Surveill Summ. 2013 Nov;1;62 Suppl 5:1-17.
  • Goodnough LT, et al. Transfusion medicine: Looking to the future. Lancet. 2003;361:161-9.
  • Land K. The Bloody Truth Medical Blog; The Truth About Blood Transfusions. http://thebloodytruth.com/risky-business-the-relative-infectious-risks-of-blood-transfusion. Aug 2012.
  • Li G, et al. Incidence and transfusion risk factors for transfusion-associated circulatory overload among medical intensive care unit patients. Transfusion. 2011 Feb;51(2):338-43.
  • Infectious Risks of Blood Transfusion. Blood Bulletin. Washington, DC. America’s Blood Centers. 2001;4(2).
  • Fatal West Nile Virus Infection After Probable Transfusion-Associated Transmission – Colorado 2012. MMWR. Aug 2013;62(31);622-24.
  • Non-infectious Serious Hazards of Transfusion. Blood Bulletin. Washington, DC: America’s Blood Centers. 2002; 5(1).
  • Prowse C, et al. Human parvovirus B19 and blood products. Vox Sanguinis. 1997;72:1-10.
  • Schreiber GB, et al. The risk of transfusion-transmitted viral infections. NEJM. 1996;334:1685-1690.
  • Stramer SL, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. NEJM. 2004;351:760-768.
  • Stramer SL. Current risks of transfusion-transmitted agents: a review. Arch Pathol Lab Med. 2007 May;131(5):702-7.
  • Technical Manual, 17th edition. Bethesda, MD: AABB Press. 2011.
  • Toy P, et al. Transfusion-related acute lung injury: incidence and risk factors. Blood. 2012 Feb;119(7):1757-67.
  • Update to Transfusion. AABB Resources. 2009;49(Suppl):107-09S.
  • US General Accounting Office. Blood Supply: Transfusion-associated risks. GAO/PEMD-971. Washington, DC: US Government Printing Office, 1997.
  • Young C. Preventing transfusion-transmitted babesiosis: Preliminary experience of the first laboratory-based blood donor screening program. Transfusion. 2012 Jul;52(7):1523-9.