Informed Consent for Transfusion

Hospitals, regions and provinces have taken different approaches to the definition of a blood product for this purpose. Some hospitals have a process for informed consent for fresh and frozen products while others include fractionated blood products as well.

• Examples of hospital informed consent information/forms
• Other resources

The physician who is ordering the transfusion should explain the risks and benefits of transfusion with the patient. An explanation of the risk of not having the transfusion is an important element. Although controversial, some hospitals have included medications that use albumin as a stabilizer in this policy.

The Royal Commission of Inquiry into the Canadian Blood System (Krever) in its 1997 interim report (recommendations 26-29) describes the processes the treating physician should perform for informing the patient of the risks and benefits of transfusion prior to the transfusion of blood products.

Recommendations from an expert working group formed by the Canadian Medical Association (1997) regarding informed consent have also been published.

An expert working group convened by Health Canada to develop Standards for Blood Safety, and later, the technical committee for CSA Standard Z902-04, Blood and Blood Components, considered the following three themes:

The Informed Consent Process

Obtaining informed consent is the responsibility of the physician who orders the transfusion of blood components. Since this may be unknown in the pre-operative setting, a process should be developed by each hospital or region providing transfusion services. The informed consent process should include, but is not limited to, the following key components:

1. Identification of roles and responsibilities for obtaining informed consent.
2. A discussion with the patient that includes the following minimum components:
   -A description of the blood product
   -The risks and benefits of transfusion
   -Alternatives
3. Mechanisms for handling refusal of transfusion, including communication to the hospital transfusion service, if indicated.
4. Mechanisms for handling patients who are unable or incapable of providing informed consent.

Active participation of nursing education departments is essential for the process to be effective because of the ongoing education and communication required to provide informed consent.

Informing Transfusion Recipients

Many hospitals have implemented systems to notify transfusion recipients. This does not come without inherent challenges. Departments outside of the hospital transfusion service must be included in this process. These include medical records and admitting departments.

Factors impacting this process include:

• Up-to-date information on the patient address and admission data is necessary to ensure mail reaches the correct address/patient. In many hospitals there is a higher incidence of transient patients thus a greater challenge.
• To ensure that deceased individuals are not sent letters regarding transfusion history, ascertain that the patient was discharged living prior to sending letter.
• Chronic transfusion recipients and other outpatients groups are special circumstances because of the frequency of transfusion and hospital status. Should they get a letter annually or bi-annually?

All these must be considered when developing a process for patient notification. Regardless, computerization is key to whether this process is implemented in a timely manner. Hospitals that do not have transfusion service computer systems will find this process most challenging and costly.

Education on the Risks

Although the benefits of transfusion will vary and depend on the clinical situation, the risks of transfusion are quantifiable and should be available to physicians in an easily accessible form. When implementing informed consent programs, the information provided to physicians will need to be reviewed and updated periodically.

Other Resources

Note: Canadian Blood Services offers no endorsement of and assumes no liability for the currency, accuracy, or availability of any information on these sites.

1. Complications and Risks of Tranfusion by Blood Component, a reference table on risks associated with some common blood components.
2. British Columbia's PBCO Physician's Guide 2004 & Quick Reference Card: Blood and Blood Product Utilization 2004.
3. e-network Forum. Informed Consent for Transfusion of Blood Components and/or Plasma Derivatives. California Blood Bank Society.
4. Godolphin W, Towle A, McKendry R. Challenges in family practice related to informed and shared decision-making: a survey of preceptors of medical students. CMAJ 2001; 165 (4).
5. Kluge EW. Informed consent in a different key: physicians' practice profiles and the patient's right to know CMAJ 1999 160: 1321-1322.
6. Moloughney BW. Transmission and postexposure management of bloodborne virus infections in the health care setting: Where are we now? CMAJ 2001 165(4).
7. Pall Corporation. Blood Transfusion: Knowing your options. No date.
8. Robb N. Informed consent and blood transfusions. CMAJ 1996 154: 396-7.
9. The University of Michigan Hospitals & Health Centers. Transfusion Procedures (includes training and competency assessment for informed consent). 2004.
10. WatchTower: Official Website of Jehovah’s Witnesses. Medical Care and Blood. 2005.
11. Wolfish WG. Competency of Adolescents to Make Informed Decisions. CMAJ 2000 163 (11).

Complications and Risks of Transfusion by Blood Component

Blood Component	Common Risks/Symptoms that are usually not life-threatening		Rare Important Risks/Symptoms that may be life-threatening
	Type of Reaction	Commonly Associated Symptoms	Type of Reaction/Risk	Commonly Associated Symptoms or Comments
Red Blood Cell Components and Whole Blood	Allergic (urticaria/pruritis)	Urticaria, wheezing or other angioedematous reactions. Rarely chills and fever are also observed.	Bacterial Contamination	All or any combination of the following symptoms: shock, chills, high fever, hypotension during or immediately after transfusion.
	Febrile	Fever and/or chills. More common in patients previously sensitized by transfusion or pregnancy.	Acute hemolysis	All or any combination of the following symptoms: shock, chills, fever, dyspnea, chest pain, back pain, headache, abnormal bleeding.
	Circulatory overload	Pulmonary edema especially in the elderly and patients with chronic severe anemia in whom low red cell mass is associated with high plasma volume.	Delayed hemolysis	Progressive unexplained fall in hemoglobin 4-14 days after transfusion, continued anemia despite transfusion therapy, fever, hemoglobinuria, hyperbilirubinemia.
			Anaphylaxis	Autonomic dysregulation, bronchospasm and/or laryngospasm, severe dyspnea, laryngeal and or pulmonary edema.
			Transfusion-associated Graft vs Host disease	Severely immunocompromised patients are at greatest risk.
			Iron Overload	Long term complication in chronically transfused patients.
			Viral Infection	Varied and dependant upon infectious agent.
			Reactions associated with Massive Transfusion
Frozen Plasma Components	Allergic (urticaria/pruritis)	Urticaria, wheezing or other angioedematous reactions. Rarely chills and fever are also observed.	Anaphylaxis	Autonomic dysregulation, bronchospasm and/or laryngospasm, severe dyspnea, laryngeal and or pulmonary edema.
	Circulatory overload	Pulmonary edema especially in the elderly and patients with chronic severe anemia in whom low red cell mass is associated with high plasma volume.	TRALI (Transfusion Related Acute Lung Injury)	Acute noncardiogenic pulmonary edema usually within six hours of transfusion
			Viral Infection	Varied and dependant upon infectious agent.
			Reactions associated with Massive Transfusion
Platelet Components	Allergic (urticaria/pruritis)	Urticaria, wheezing or other angioedematous reactions. Rarely chills and fever are also observed.	Bacterial Contamination	All or any combination of the following symptoms: shock, chills, high fever, hypotension during or immediately after transfusion.
	Febrile	Fever and/or chills. More common in patients previously sensitized by transfusion or pregnancy.	Refractoriness	Lack of incremental rise in platelet count after transfusion of platelets.
			Viral Infection	Varied and dependant upon infectious agent.
			Anaphylaxis	Autonomic dysregulation, bronchiospasm and/or laryngospasm, severe dyspnea, laryngeal and or pulmonary edema.
			Transfusion-associated Graft vs Host disease
			Reactions associated with Massive Transfusion

References

1. Circular of Information for the Use of Human Blood and Blood Components. Canadian Blood Services. 11/02.
2. Circular of Information for the Use of Human Blood and Blood Components. American Association of Blood Banks, America's Blood Centers, American Red Cross. July 2002.
3. Physician's Guide 2001, Informed Consent for Blood and Blood Products. BC Provincial Blood Coordinating Office. 2001.
4. Kleinman S, Chan P, Robillard P. Risks associated with transfusion of cellular blood components in Canada. Transfus Med Rev 2003 Apr.;17(2):120-62. 

Obtaining the Component from the Laboratory

Before Obtaining the Product

Prior to obtaining the blood component from the hospital transfusion service, the following actions should take place:

1. Check the patient's chart for the physician's order for transfusion and for documentation of informed consent for blood transfusion;
2. Establish intravenous (IV) access and set up a blood administration set.

Messenger

The messenger is defined as the person who transports the blood component from the transfusion service to the patient care area. This person's training and qualifications can vary greatly and range from the patient picking up a product to a nurse or physician, depending on the size of the hospital and the day/time.

Standard Operating Procedures and a training program should be developed and implemented for this important role.

Pneumatic Tube Delivery Systems

Some hospital transfusion services transport blood to patient care areas using a pneumatic tube system. Processes must be established and monitored to prevent delay and misdirection of blood components to the intended destination. As well, additional procedures should be established to ensure the temperature of the blood components is maintained according to established standards.

If the Product is not Transfused Immediately

Blood components must also meet specific criteria if not used and returned to the laboratory.

Storage of blood components outside the hospital transfusion service (satellite storage) requires specific blood component refrigerators and the same criteria for monitoring, calibration and maintenance as the equipment in the transfusion service.

Patient and Unit Identification

The most common cause of an acute intravascular hemolytic transfusion reaction is failure to identify the patient either during specimen collection or immediately prior to initiating transfusion.

Proper identification of the patient at the bedside prior to initiating the transfusion is of paramount importance and is arguably the most important step in ensuring safe transfusion.

The following is an example of the steps required to identify the patient and component prior to transfusion. Prior to connecting the blood product to the blood administration set, the following must be checked at the patient bedside:

• Physician's order to transfuse
• Informed consent documentation (signature)
• Patient's full name, date of birth and medical record number on the
  - patient's ID band
  - product compatibility label
  - requisition or form accompanying the unit from the laboratory, if applicable
  - blood transfusion record
• Information on the component bag with the information on the compatibility label
  - the unit number
  - blood group of the component
  - blood group of the patient

Note: blood groups of the patient and unit are usually identical, but, in special circumstances, compatible but non-identical groups may be issued by the hospital transfusion service.

• Date of expiry on the blood component
• All blood components should be visually inspected prior to administration.

STOP
If any discrepancy is found during the comparison of information on the unit and the patient identification, the transfusion must not be initiated until the discrepancy is resolved.

Latex Allergy Information

Incidence and Symptoms

Since the introduction of universal precautions, the incidence of allergic reactions to natural rubber latex has been reported among healthcare personnel.

Symptoms of reaction include but are not limited to:

• dermatitis
• conjunctivitis
• rhinitis
• urticaria
• angioedema
• asthma
• anaphylaxis

Another recognized contributing factor to latex sensitivity is the powder or cornstarch used in latex gloves. This powder has been shown to adhere to latex particles, aggravating respiratory symptoms.Latex allergy precaution is a relatively recent issue to affect healthcare. With increased use of latex has come increased hypersensitivity, causing many hospitals to develop policies to reduce exposure to latex.

Prevalence

Prevalence varies by job category within healthcare professions with highest reports from operating room and dental personnel.

Factors linked to latex sensitivity among healthcare personnel include:

• presence of other allergic conditions
• elevated total IgE levels
• allergies to cosmetics or food (especially linked to allergies to bananas, avocados and chestnuts)
• frequency and duration of glove use
• number of years working in healthcare

Other groups at risk for latex allergy include but are not limited to:

• those exposed to repeated surgical procedures
• those exposed to repeated surgical procedures
• neural tube defect disorders such as spina bifida
• those exposed to repeated intravenous or catheterization treatment

Precautions for Transfusion

Some components of blood collection sets and fractionated blood product containers may contain latex. Standard Operating Procedures (SOPs) have been developed by some laboratories for component preparation that avoids latex or uses products that do not contain latex. A mechanism must be in place to notify the laboratory that possible transfusion recipients are sensitive to latex in order to reduce exposure.

Canadian Blood Services (CBS) maintains a list of contacts for manufactured products to obtain additional information on latex containing products.

Further Reading

Note: Canadian Blood Services offers no endorsement of and assumes no liability for the currency, accuracy, or availability of any information on these sites.

• American College of Allergy, Asthma and Immunology
• Latex allergy or allergic reactions to latex-containing medical devices and products (Centres for Disease Control and Prevention)
• Work-related asthma & latex allergy. Sorting out the types, causes and consequences. Postgraduate Medicine June 1999;105(7).
• AANA Latex protocol (American Association of Nurse Anesthetists)
• Latex allergy links (US Federal Government)

Equipment Used in Administration of Blood Components

The equipment used in transfusion of blood products includes filters, tubing, needles, pumps, blood warmers, and rapid infusion devices. Blood components manufactured by Canadian Blood Services (CBS) and Héma-Québec (H-Q) are leukoreduced by filtration but a blood filter is still required at the time of transfusion.

Administration Sets

Filter size

The transfusion of all components requires the use of a filter to remove debris in the form of blood clots and aggregates of cells. All blood and blood products for intravenous use should be given through an appropriate administration set with a filter. "Standard" blood administration sets contain a plastic mesh designed to remove most particles that are larger than 170 um in diameter. The current standard blood product filters have a pore size which is adequate to remove large cell aggregates and fibrinous material; this size is thought to be 170 um. This is not accurate as the filters vary from 140-260 um depending upon the manufacturer. However, the term “standard” or “170 um” is accepted common terminology. Some manufacturers are now producing regular blood administration sets with in-line filters of 80 um pore size. These are not microaggregate filters; they may be used interchangeably with sets containing standards filters for all blood products.

Needle Size

Red Blood Cells (RBC) should be administered through a large bore needle, catheter or cannula, preferably 19 gauge or larger where vascular access permits. Other blood components may be infused with smaller gauge needles. In patients who have small veins, pediatric patients and in adults whose large veins are not accessible, smaller gauge needles are necessary. Transfusion for a newborn may be administered through a very small 23 gauge needle.

Other Equipment

• Blood Warmers
• Equipment for Pooled Unit or Bolus Infusion
• Rapid Infusion Devices
• Volumetric Infusion Pumps
• Blood Product Storage Equipment

Fractionation products may require special administration procedures.
Therefore, the individual package insert should be consulted.

Infusion and Monitoring

Monitoring the Patient

Each hospital must set policy for the frequency of monitoring and recording of vital signs.

For example, the patient's temperature should be recorded after 15 minutes and then every 30-60 minutes until one hour after the completion of the transfusion.

The Registered Nurse initiating the transfusion should remain with the patient for the first 15 minutes and then monitor the patient closely for the duration of the transfusion. Ambulatory patients should not be allowed to leave the patient care area during transfusion.

Infusion of all blood products should begin within 30 minutes from the time the component is removed from the monitored blood storage refrigerator. If any delays that exceed this length of time are expected, the components must be returned to the monitored blood storage refrigerator. Prior to initiation, record the pre-transfusion vital signs and time.

Rate of Infusion

Blood components should be transfused over the period of time prescribed by the treating physician. The rate of infusion depends upon the clinical condition of the patient and the product being transfused (consult product inserts of fractionated products).

Unless otherwise indicated by the patient's clinical condition, the rate of infusion of red blood cells should be no greater than 5 mL/min for the first fifteen minutes of the transfusion. The patient should be observed during this period, as some life-threatening reactions could occur after the infusion of only a small volume of blood.

A unit of red blood cells (RBC) can be infused in 45-90 minutes in most patients. The transfusion should not take longer than four hours because of the risk of bacterial proliferation at room temperature.

Pediatric infusion rate is usually 2-5 mL/kg/hour. Units are sometimes aliquoted by the hospital transfusion service (depending on hospital services and policies) into several bags or syringes containing small volumes. Contact the hospital transfusion service if this is indicated.

Similarly, blood that is not hung within thirty minutes of removal from the hospital transfusion service department or temperature controlled blood product storage device should be returned until needed.

Air should never be introduced into the blood component container or into the administration set, because of risk of air embolism.

Administration of blood under pressure to speed infusion may contribute to hemolysis and should always be supervised by a nurse or physician.

Circulatory overload, leading to pulmonary edema, can occur after transfusion of excessive volumes or at excessively rapid rates. This is a particular risk in the elderly and in patients with chronic severe anemia in whom low red cell mass is associated with high plasma volume. Except for the replacement of acute, massive blood loss, infusion rates should, ordinarily, be no greater than 2-4 mL per kg body weight per hour, and for patients at known risk of hypervolemia, a rate of no faster than 1 mL/kg/hr is advisable.

After platelets are transfused, it is preferred (but optional) to rinse the entrapped platelets from the filter by flowing 50-100 mL of 0.9% Saline Solution (USP) through it.

Additional information on infusion may be found in the Circular of Information for the Use of Human Blood and Blood Components (Sections A.4 #11 Rate of infusion and A.5 #7b Circulatory overload reactions).

Medications and Intravenous Solutions

Only normal saline (0.9% USP) should be used to prime the intravenous line before blood components are infused and to clear the line after infusions.

If intravenous medications are required, they must not be added directly to blood component bags. Use of a Y-extension allows medications to be administered through the alternate limb of the Y and flushed with a compatible solution before blood is infused.

Additional information on infusion may be found in the Circular of Information for the Use of Human Blood and Blood Components Section A.4 #5

Incompatible Solutions

The following are solutions that are not compatible with red cells:

• Ringer's lactate
• Glucose

Ringer's lactate and other solutions containing calcium promote clotting by counteracting the calcium binding effect of the citrate anticoagulant. Glucose (dextrose) solutions cause agglomeration of the red cells and decreased red cell survival, or even acute hemolytic reactions.

Further Reading

Documentation of Transfusion

Documentation requirements vary from hospital to hospital but there are a few required pieces of information that must be documented on the patient's medical record.

Documentation of the following pieces of information is important in order to trace transfusion of blood components if a new threat to the blood supply is identified:

1. Blood component name (type, e.g., RBC, pooled platelets, FFP);
2. Donation (unit) number, including centre code (i.e., three-digit centre code, one-digit check digit and six-digit serial number). Some facilities allow the use of stickers from the back of the donor unit or lot number and manufacturer;
3. ABO/Rh of the component, if applicable;
4. Time transfusion of each unit was started;
5. Signatures of the individuals identifying and initiating the transfusion;
6. Time the transfusion was discontinued;
7. Volume administered;
8. Whether a reaction to the transfusion occurred.

Pooled Blood Components

The compatibility label attached to the donor unit may contain all of the numbers of the units contained in the pool, or, when a transfusion service computer system is used, the computer may assign a "pool number" to the unit. In either case, the compatibility label should indicate the number of unit in the pooled blood component.

Do Not Remove...

The compatibility label on the blood component unit until the transfusion is discontinued.

Administration of Blood and Blood Products: Further Reading

The literature below is organized by subtopics that correlate to how this site is structured.

Note: Canadian Blood Services offers no endorsement of and assumes no liability for the currency, accuracy, or availability of any information on these sites.

General

1. Bradbury M, Cruickshank JP. Blood transfusion: crucial steps in maintaining safe practice. Br J Nurs 2000 Feb.10-23;9(3):134-8. [Medline].
2. Wilkinson J, Wilkinson C. Administration of blood transfusions to adults in general hospital settings: a review of the literature. J Clin Nurs 2001 Mar.; 10(2):161-70. [Medline].

Pooling of Platelets

1. e-Network Forum. Usage of pooled platelets vs pheresis platelets. California Blood Bank Society website. (Mar. 2001).
2. Mertens G, Muylle L, Goossens H. Possible implication of sterile connecting device in contamination of pooled platelet concentrates. Transfus Sci 1997 Sep.; 18(3):387-92. [Medline].