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TRANSFUSION MEDICINE

Facilities providing Transfusion Services must follow applicable FDA regulations. The AABB Standards for Blood Banks and Transfusion Services provide requirements not only for those accredited by AABB, but also for those facilities required by state law to follow the Standards. They provide excellent guidelines for all other facilities, and are referenced extensively in the College of American Pathologists’ Transfusion Medicine accreditation checklist.

This section provides information based on the Standards, regulatory requirements and United Blood Services’ practices relating to transfusion and post-transfusion activities.

GENERAL GUIDELINES

United Blood Services distributes a variety of blood components for transfusion. Each type of component requires certain pre-transfusion testing and selection of the appropriate component based on recipient and donor ABO/Rh determinations. Should there be any concerns about the suitability or quality of a blood component received from your blood center, please contact the center directly.

If you have other questions concerning issues relating to Transfusion Medicine please contact your blood center for resources that might be available in your area. On our Web site we have educational information and a listing of Web-based resources that may be helpful.

  • For information related to particular blood components, refer to the Blood Components and Derivatives section of this handbook.
  • For information related to post-transfusion recipient or post-donation donor issues, refer to the Regulatory section of this handbook.
  • For information relating to indications and benefits of transfusion, refer to the Circular of Information for the Use of Blood and Blood Components. This brochure is produced jointly by the American Associate of Blood Banks, America’s Blood Centers, and the American Red Cross. You can view the current version of the COI online. Copies are also available from your United Blood Services center.

 

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.


Compatible Blood Components for Transfusion

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

Red Blood Cells: See D requirement
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

 

Frozen Plasma: No D Requirement
Recipient’s ABO Group Component ABO Group
O O, A, B, OR AB
A A OR AB
B B OR AB
AB AB

 

Platelets: See D Requirement
Recipient’s ABO Group Component ABO Group
O O, A, B, OR AB
A A OR AB
B B OR AB
AB AB

*NOTE: If group compatible platelets are not available, any type can be given to a patient > 2 years of age.

Cryoprecipitate: No ABO/D specific criteria for this component

 

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 D Negative Preferred

 

 

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, 2006

AGENT RISK/UNIT TRANSFUSED % TRANSMISSION
B19 erythrovirus 1:3,300-40,000 Low
Babesia & Malaria <1:1 million Unknown
Bacteria (platelets) 1:3,000-5,000 untested
<1:10,000 tested
>40%
Bacteria (RBCs) 1:1,000 1:10 million fatal
HAV 1:1 million 90
HBV 1:137,000 70
HCV 1:1-2 million 90
HIV 1:2 million 90
HTLV 1:641,000 30
WNV Seasonally & geographically variable Variable

K-A Nguyen, BCP, 1/4/06

 

Non-infectious Risks of Blood Transfusion, 2006

ADVERSE OUTCOME INCIDENCE PRESENTATION
Acute Hemolytic 1:38,000-70,000 Chills, fever, pain at infusion site, hemoglobinemia, shock, acute renal failure, DIC
Allergic – Anaphylactic 1:20,000-50,000 Hypotension, wheezing, respiratory distress, local edema
Allergic –
Non-anaphylactic
1-3% Urticaria, pruritis, flushing
Circulatory Overload 0.1-1% Dyspnea, hypertension, pulmonary edema
Delayed hemolytic 15,000-11,000 Drop in Hgb,
new RBC antibodies, bilirubinemia
Febrile Non-hemolytic 0.5-6% RBCs
1-38% platelets
Fever, chills/rigors
GVHD Rare Rash, diarrhea, hepatitis, pancytopenia
Hypotension Rare Flushing, hypotension assoc. with ACE inhibitors & LR blood filters
Metabolic risk in neonates    
TRALI 1:5,000-190,000 Hypoxemia, dyspnea, hypotension, pulmonary edema
Under-transfusion 0.1-1% Hypoxemia, bleeding (esp. due to dilutional coagulopathy)

K-A Nguyen, BCP, 1/4/06

 


References

Busch MP, Glynn SA, Stramer S, 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.

Goodnough LT, Sander A, Brecher ME. Transfusion medicine: Looking to the future. Lancet (2003) 361:161-9.

“Infectious Risks of Blood Transfusion”, in Blood Bulletin (2001) 4(2). Washington, DC: America’s Blood Centers.

“Non-infectious Serious Hazards of Transfusion,” in Blood Bulletin (2002) 5(1). Washington, DC: America’s Blood Centers.

Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood products. Vox Sanguinis (1997) 72:1-10.

Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. NEJM (1996) 334:1685-1690.

Stramer SL, Glynn SA, Kleinman SH, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. NEJM (2004) 351:760-768.

Technical Manual, 15th edition. Bethesda, MD: AABB Press, 2005.

US General Accounting Office. Blood Supply: Transfusion-associated risks. GAO/PEMD-971. Washington, DC: US Government Printing Office, 1997.

Compiled by Kim-Anh Nguyen,
Blood Centers of the Pacific, Jan. 4, 2006.


ADVERSE TRANSFUSION REACTIONS

A transfusion should be stopped immediately whenever a transfusion reaction is suspected and an investigation performed according to institution procedures. Should there be an issue, where after investigation, the reaction needs to be reported to United Blood Services 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 Report of Transfusion Adverse Reaction form (BS 962). The following tables list symptoms associated with types of 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)

(Link to more information on 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
Circulatory Overload Acute pulmonary edema due to volume overload • Dyspnea, orthopnea
• Severe headache
• Hypertension, tachycardia
• Congestive heart failure
• Acute pulmonary edema
Metabolic reactions   • Citrate toxicity
• Hyperkalemia
• Hypocalcimia
• Hypothermia
• Respiratory alkalosis

 

 

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 for > 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)

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.

Definition of TRALI:

• ALI:


  • Acute onset (During or within 6 hours of transfusion)
  • Hypoxemia:
    ο PaO2 /FiO2 ≤ 300,
    ο 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 Prerequisites For Performing A Laboratory Workup:

  • A laboratory workup of a TRALI case is expensive.
  • Donors may experience anxiety and/or concern that their blood donation may have resulted in harm to a recipient.
  • For these reasons, the transfusing institution has the obligation of providing complete information on the TRALI case to the blood center.
  • Information to be provided should include:
    • Sufficient clinical data to confirm the TRALI diagnosis and to exclude other causes of ALI.
    • The results of any laboratory tests performed to rule out other transfusion reactions.
    • Data as to the storage age of the transfused components for evaluating the neutrophil priming hypothesis of TRALI pathogenesis.

Suggested Laboratory Investigations:

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 cross-match between donor serum a patient white blood cells

 

 

 

Transfusion Associated Infections

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: retrovisruses, 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, United Blood Services 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.

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.

 

COMPATIBILITY SERVICES PROVIDED
BY UNITED BLOOD SERVICES

Contracted Services

Several United Blood Services centers provide compatibility testing services for transfusion facilities that do not or choose not to perform their own compatibility testing for units they transfuse. This is a process that requires completion of a checklist prior to signing the testing agreement to provide these services. The transfusion facility must have policies and procedures defined that cover the pre-analytical and post-analytical transfusion related processes and ensure that appropriate regulations and transfusion standards set by the AABB are met.

If your facility is interested in these services, please contact your blood center to determine if this is an option in your area.

Part of the contracted information is contained in the following document which defines the responsibilities of United Blood Services as the Transfusion Service and the facility as the Transfusing entity:

Transfusion Service Guidelines (Download CT0119)


 



 
 

 

 

 

 

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