Version May 2024
INTRODUCTION — Home transfusion (also called out-of-hospital transfusion [OOHT]) may be an option for patients who are transfusion-dependent, chronically ill, or have impediments to receiving blood in traditional settings. Standard operating procedures (SOPs) represent a necessary basis for transfusion safety by providing detailed, standardized steps.
This topic provides broad guidelines and a framework for developing home transfusion SOPs; it identifies aspects of home transfusion for which SOPs are essential. (See 'Importance of facility-specific input' below.)
General principles of home transfusion, including patient profile, indications, exclusion criteria, and roles of the physician and nurse, are discussed separately. (See "General principles of home blood transfusion".)
OVERVIEW
Rationale and purpose — Nontertiary hospital facilities, as well as tertiary hospitals and blood centers, have shown interest in out-of-hospital transfusions (OOHTs).
Transfusion in a home or out-of-hospital setting is distinct from transfusion in a hospital or other health care facility due to reduced availability of emergency medical care and diagnostic tests should a potentially serious complication occur. This inherent difference compounds risks of transfusion. SOPs can minimize these risks and provide a foundation for transfusion safety.
Transfusion safety is strengthened by the development of written SOPs (paper or electronic) that are:
●Based on applicable regulations and blood banking standards.
●Approved by medical and administrative leadership.
●A basis for training and reinforcing the proficiency of transfusing personnel.
●Followed by (and easily accessible to) personnel to which they are applicable.
One particularly relevant safety concern is a possibility that blood could be administered to the wrong patient (mistransfusion) and result in an acute hemolytic transfusion reaction (AHTR). (See "Hemolytic transfusion reactions", section on 'Acute hemolytic transfusion reactions'.)
Mistransfusion has been well documented in tertiary care centers [1-4]. Causes range from mislabeling of the pretransfusion specimen (clerical error) to administration of blood to a patient without a means of identification such as an arm band or use of incorrect patient identification. Any of these errors can also occur in a home transfusion setting. (See "Hemolytic transfusion reactions", section on 'Mechanism of RBC destruction'.)
Importance of facility-specific input — While a general framework is useful for developing SOPs for home transfusion, flexibility is required for some details of the SOP, and contents should be developed with the specific facility in mind.
●Each organization is legally and medically responsible for its own SOPs.
●Procedures may vary across organizations; appropriate transfusion practices can be adhered to without resorting to a one-size-fits-all approach.
●The SOP development process facilitates consideration of facility-specific procedures and rationales.
Companion documents — It is helpful and generally necessary to develop SOP companion documents. Examples include:
●Physician order form for the transfusion, and standing orders, if agency policy, for managing some transfusion complications
●Informed consent document
●Checklist for assessment of the transfusion site
●List of supplies and materials
●Transfusion report/record, which at a minimum should include product information (patient and donor ABO type and product modifications); fields for documenting that patient identification was performed; vital signs; volume transfused; cooler and product temperature (if available); and results of visual inspection of the units
●Post-transfusion patient instructions
Useful prototypes of these are found in the Association for the Advancement of Blood & Biotherapies (AABB) monograph, Out-of-Hospital Transfusion Therapy [5].
Validation, review, and training
●Validation – In conformance with regulations, SOPs should be tested and stressed in simulations prior to implementation. This activity, referred to as validation, may identify problems including flaws in the protocol, omissions, or lack of clarity.
●Review – SOPs should be modified whenever procedures are changed and should also be periodically reviewed and updated to incorporate new or revised regulations, standards, and other changes.
For practitioners, transfusionists, or home health care agencies that have not been previously involved in transfusion-related procedure development, input from transfusion medicine specialists is advised before and after the SOP is created.
Procedures should be approved by medical and administrative leadership prior to implementation.
●Training – The transfusion/infusion agency or company should have documented processes for training that would apply to their home transfusion services.
Ongoing validation, review and training are important components of the SOP (table 1).
Other resources — Additional information is available from several sources and include the following:
●Review articles [6,7]
●Resources from the AABB
•The AABB Technical Manual [8]
•AABB Standards for Blood Banks and Transfusion Services for OOHT [9-11]
●The US Food and Drug Administration (FDA)-approved and regulated package insert for blood components, the "Circular of Information for the Use of Human Blood and Blood Components" [12]
●The American Red Cross Blood Services Compendium of Transfusion Practices, 4th Edition [13]
PRETRANSFUSION ACTIVITIES
Assessment of the home site — The SOP should list activities required during the initial visit to the patient's home. These are summarized in the table (table 1).
Requirements for home transfusion should include:
●A landline telephone or mobile device with a working signal
●Assurance that another responsible adult will be present during the transfusion
●Emergency personnel access to the room in which the transfusion will be given
These requirements are intended to ensure that the transfusionist has assistance in carrying out appropriate document checks and obtaining help if a complication arises.
Informed consent — The SOP should provide instructions for obtaining informed consent from the intended transfusion recipient. Unless consent is obtained by the patient's clinician or other qualified health care provider in advance of the home visit, the on-site transfusionist would optimally be the individual responsible for participating in obtaining informed consent, affixing identification to the patient (usually a wristband) and collecting pretransfusion specimens.
According to AABB standards (see 'Other resources' above), elements of consent should include a description of risks, benefits, and treatment alternatives; the opportunity for the intended recipient to ask questions; and the right of the patient to accept or refuse transfusion.
Collection and labeling of pretransfusion specimens — As in other pretransfusion settings, appropriate specimens and specific tubes required by the collaborating blood center for performing tests of record should be collected within three days of the anticipated transfusion.
The SOP should list the following:
●Tubes should be labeled with two independent identifiers. Typically these include the patient's name plus their date of birth or medical record number. The date and time of collection and the initials or name of the transfusionist or health care professional collecting the specimens should also be included. Labels should be attached to the tubes before the person collecting the specimen leaves the patient's bedside. Applicable standards and regulations should be followed.
●Patient identification such as a wristband should legibly show at least two independent identifiers, typically the patient's full name and one additional identifier such as date of birth or medical record number. The identifiers on the wristband must be identical to those on the pretransfusion specimens. Applicable standards and regulations should be followed.
●Labels for other patients should not be taken into the patient's house or room.
●If a specimen does not meet labeling requirements, the SOP should state that it be rejected and that a new specimen should be obtained that does conform to labeling requirements.
If these specifications are not met, the blood-issuing facility should not accept the specimen. As a result, issuing of blood may be delayed.
At this visit, it is also appropriate to determine that the patient has adequate venous access for the transfusion.
Coordination with local blood provider — Appropriate indications for transfusion should be evidence-based; ideally this is done within the context of a Patient Blood Management (PBM) program [14]. (See "Indications and hemoglobin thresholds for RBC transfusion in adults", section on 'Hospital-wide oversight programs/patient blood management'.)
The SOP should provide for documentation of the type and amount of each component, with details for each patient coordinated with the local blood provider.
Suggested approaches for specific components that may be transfused in the home setting are listed in the following sections:
●Red blood cells (RBCs) – (See 'Packed red blood cells' below.)
●Platelets – (See 'Platelets' below.)
●Plasma and Cryoprecipitate – (See 'Plasma and Cryoprecipitate' below.)
The number of components transfused in a single procedure should be limited to no more than two (eg, no more than two units of RBCs; no more than one unit of RBCs plus one unit of plasma). These limits are recommended to minimize the risk of transfusion-associated circulatory overload (TACO). If the patient has potential risks for fluid overload by receiving two units, home transfusion should be reconsidered. (See "Transfusion-associated circulatory overload (TACO)".)
In keeping with standard practices, when components are released, sign-out should be performed by qualified laboratory personnel and the party responsible for transporting and transfusing the products.
Leukoreduction, pathogen inactivation, and/or irradiation
●Leukoreduction – The majority of blood collecting facilities in the United States issue RBC and platelet units that have undergone pre-storage leukoreduction, which reduces the risk of febrile nonhemolytic transfusion reactions (FNHTRs). (See "Practical aspects of red blood cell transfusion in adults: Storage, processing, modifications, and infusion", section on 'Pre-storage leukoreduction' and "Platelet transfusion: Indications, ordering, and associated risks", section on 'Collection methods'.)
Leukoreduction is especially important in nonhospital settings because management of complications may be more challenging. (See 'Management of complications' below.)
Rarely, blood may be collected and issued by a facility that does not perform leukoreduction. In such cases, bedside leukoreduction might be performed. When bedside leukoreduction is used, administering transfusionists should be trained in proper use of the filter, and a mechanism for ensuring proper use and quality assurance should be developed. Transfusion personnel should also be aware of rare reports of hypotensive reactions observed in association with bedside leukoreduction filters [15-17]. Hypotension typically resolves when the transfusion is stopped. Further information about this issue and the preference for pre-storage leukoreduction can be obtained from the US Food and Drug Administration (FDA) website [18].
●Pathogen inactivation – Pathogen inactivation technologies are applied to the blood component by the preparing facility before the component is issued. These include methods that work by either damaging pathogen lipids or preventing nucleic acid (DNA or RNA) replication. Pathogen-reduced components carry a lower risk of certain infectious organisms. Methods and available products are discussed separately. (See "Pathogen inactivation of blood products".)
●Irradiation – Irradiation is used to prevent transfusion-associated graft-versus-host disease (TA-GVHD), which can occur with partial matching of human leukocyte antigen (HLA)-type or in individuals with profound immunosuppression, such as an individual with an immunodeficiency syndrome or hematologic malignancy, or the recipient of an allogeneic hematopoietic stem cell transplant. Irradiation is used for cellular products if there is a directed donation from a family member, genetically homogeneous population, primary immunodeficiency syndrome, or hematologic malignancy, and other indications. (See "Transfusion-associated graft-versus-host disease", section on 'Risk factors'.)
Specific components
Packed red blood cells — Indications for out-of-hospital transfusion of packed red blood cells (pRBCs) are based on the same or similar guidelines for transfusion in a medical facility, including chronic and/or severe anemia. The main exception is active bleeding, which requires additional medical intervention. If other aspects of the patient's medical condition are severe enough to require hospital evaluation, then home transfusion is unlikely to be appropriate. Conversely, if the patient's condition is not severe enough to require care at a medical facility, home transfusion may be reasonable.
The number of ordered units is determined by the patient's clinical status, hemoglobin level and rate of decline, and volume status and tolerance (eg, an individual with underlying heart failure may tolerate less volume). The number of units transfused in a single procedure should be limited to two, as discussed above. (See 'Coordination with local blood provider' above.)
Typical hemoglobin thresholds are discussed separately. (See "Red blood cell transfusion in infants and children: Indications" and "Indications and hemoglobin thresholds for RBC transfusion in adults".)
Platelets — Indications for platelet transfusion depend on the patient's clinical status, platelet count, and rate of decline. (See "Platelet transfusion: Indications, ordering, and associated risks".)
Platelets are manufactured by apheresis (also called "single donor platelets") or prepared from whole blood. Whole blood-derived platelet concentrates are generally pooled, which increases exposure to allogeneic donors. Some blood centers collect apheresis platelets in platelet additive solution (PAS) in which the plasma volume is reduced by approximately 65 percent; this lowers the risk of minor allergic and febrile nonhemolytic transfusion reactions (FNHTRs) [19,20].
Platelets are stored at room temperature, which is conducive to bacterial growth and increases the risk of transfusion-transmitted bacterial infection (TTBI) or sepsis. Pathogen inactivation technologies or additional culturing or testing (eg, secondary rapid testing after primary culture is performed) can reduce this risk. In September 2019, the FDA issued a requirement that one of these two methods be applied to all platelet transfusions to reduce the risk of TTBI from platelets, as discussed separately. (See "Platelet transfusion: Indications, ordering, and associated risks", section on 'Strategies for reducing bacteria and other pathogens'.)
Plasma and Cryoprecipitate — Plasma is not appropriate as a source of albumin or nutrients, as a volume expander, to reverse warfarin in the absence of bleeding, or to "correct" a minimally elevated prothrombin time/international normalized ratio (PT/INR <2.0) in a nonbleeding or preoperative patient. It can be used for factor replacement when a specific factor concentrate is not available. (See "Clinical use of plasma components" and "Factor XI (eleven) deficiency", section on 'Factor XI replacement products (FFP and factor XI concentrate)' and "Rare inherited coagulation disorders", section on 'Management of specific deficiencies'.)
Cryoprecipitate contains fibrinogen, factor XIII, factor VIII, von Willebrand factor, and fibronectin. However, use in a home transfusion setting would be unlikely due to the availability of recombinant or plasma-derived clotting factor concentrates for most of these factors. The main indication for Cryoprecipitate is replacement of fibrinogen or other clotting factors when a purified factor product is not available. Indications and dose calculations are discussed separately. (See "Cryoprecipitate and fibrinogen concentrate".)
TRANSFUSION ADMINISTRATION
Transport and storage — Unlike transfusion in a hospital or infusion center, transport and storage of blood components for home use may involve additional time and unpredictable conditions, especially related to temperature control and maintenance of physical integrity of the unit.
The SOP should specify how the units will be signed out from the issuing facility, protected, and maintained at an appropriate temperature (table 1). Component sign-out should be performed by qualified laboratory personnel and the party responsible for transporting and transfusing the products. (See 'Coordination with local blood provider' above.)
In the United States, the transport of blood falls under US Food and Drug Administration (FDA) regulations. The issuing facility should validate its shipping procedures and devices to meet FDA requirements. Validation involves simulations that test the shipping system to ensure that products will be delivered intact and remain within acceptable temperature ranges.
●Red blood cell (RBC) units should be packed with a coolant that maintains a 1 to 10°C temperature range.
●Platelet units can be maintained at the required 20 to 24°C range by shipping at room temperature (for short distances) or by packing them with commercially available thermostable material.
Measurement of the temperature within the transport device upon opening may provide additional assurance that proper temperatures have been maintained. The issuing center may assist by either placing a thermometer in close proximity to the components or by applying a colorimetric temperature sensitive device on the component. One such device changes from blue to nonblue when the temperature of an RBC unit exceeds 10°C. Portable temperature monitors are also available for platelets. Manufacturers' instructions should be followed when using such devices.
The SOP should also state that upon delivery to the final destination, the transport container should not be opened until preparations for transfusion are complete, and that it should be opened only by the transfusionist. A component should never be placed in a home refrigerator or an unmonitored refrigerator, even one in a medical office, skilled nursing or rehabilitation facility, or other facility that may have refrigerators for storing pharmaceutical products. After the shipping container is opened, the transfusionist should document the temperature of the temperature-monitoring device in the transporter.
The transport SOP should specify that if the indicator shows an out-of-range temperature, the issuing blood center should be contacted immediately for instructions that could include returning the untransfused product. If the blood center or hospital blood bank cannot be contacted, the unit should not be transfused. Although the issuing blood center should have inspected the blood or platelets for defects prior to issue, the transfusionist should also inspect the units for defects such as leaks, breakage, non-adherent label or tie tag, or abnormal appearance of the blood products.
Patient identification — Proper patient identification is essential in preventing acute hemolytic transfusion reactions (AHTR) due to mistransfusion such as wrong blood being given to the patient. The SOP should specify the procedures for patient identification, which include:
●Two-person document check – Hospitals or infusion centers have multiple health care professionals who can assist with patient identification and review of relevant documents and labels for accuracy. In the home setting, typically only one health care professional (the transfusionist) is present. However, as in the hospital or infusion center, patient identification procedures should involve two people who are not the patient.
●Bedside clerical check – Immediately before the transfusion, the transfusionist and other adult in attendance (not the patient) should carry out a "bedside clerical check." The patient's identification band, which should have been applied prior to transfusion (preferably during an earlier home visit, although it may be done at the same visit) should still be on the patient and should be legible; it is checked for accuracy and compared with the patient's name and identification numbers that are affixed to the component and listed on accompanying blood bank documents. This information should be compared item by item.
●Patient self-identification – If capable, the patient should be asked to clearly state their name and date of birth.
If any inconsistencies in the above are observed, the issuing facility should be contacted and may instruct that the blood be returned untransfused.
Blood component infusion — The SOP should specify:
●Tubing and transfusion supplies – Includes the type of infusion tubing and standard infusion filter and specifies whether a bedside leukoreduction filter is needed.
●Infusing solution – The only solution acceptable for transfusion in the home is sterile physiologic saline. Other supplies such as medications and equipment (eg, appropriate gauge needles) and their proper use should be listed. All supplies and equipment should be used as intended and in accordance with manufacturers' instructions and applicable regulations.
●Infusion rate – The SOP should state that an infusion rate appropriate for the patient's age, cardiovascular status, and other underlying medical conditions, be determined by the ordering physician. It should also state that the infusion should not take longer than four hours in total.
●Monitoring – The SOP should detail patient monitoring and procedures associated with the actual transfusion. It should state the instructions that the patient must receive prior to the transfusion, especially to report any change in physical sensation or condition during the transfusion. It should outline how often the patient's temperature and vital signs should be taken and where the information should be recorded (which section of the transfusion report). (See 'Companion documents' above.)
Suggested minimum times and intervals for checking temperature, pulse, blood pressure, and respiratory rate are as follows:
•Immediately beforehand
•Every 15 minutes for the first hour
•Every 30 minutes thereafter
•15 to 30 minutes after the transfusion is complete
The transfusionist may make these assessments more frequently. The patient should also be observed during and after transfusion for signs or symptoms of a transfusion reaction or complication. There is no standard requirement for the duration of observation after the transfusion has been completed; this depends on the patient's clinical status and whether any complications occurred.
Disposal of tubing and needles — The proper disposal of used blood bags, tubing, needles, and other detritus should be addressed. A sharps container should be used for needles and other sharp devices such as a broken tube that contained blood.
Any items that could potentially be contaminated with blood should not be discarded in the patient's home; they should be disposed according to hazardous waste regulations or standards. If the transfusing agency does not have an appropriate means for disposing of waste products, one possible approach is to return these materials to the issuing facility for disposal.
MANAGEMENT OF COMPLICATIONS — It is critical that the SOP for transfusion complications contains specific and complete information for recognizing and managing adverse events in the peritransfusion period. Personnel should be trained, routinely undergo competency assessment, and be fully knowledgeable with this and all other applicable procedures. The attending physician, home services agency medical director, and the blood provider medical director may determine in advance the specific complications for which the transfusionist should consult with a physician. Complications that require consultation with a physician should be included in the SOP.
●Medications – Some complications require pharmacologic intervention; thus, the SOP should list medications, method of administration, dose, and the indications for each medication that may need to be administered. If it is the policy of the transfusing agency, consideration should be given to obtaining standing orders for administration of medications to manage some complications. The SOP should also specify the circumstances under which a medication should be given as needed (prior to consulting with the physician), such as, epinephrine for anaphylaxis.
●Transfer to a medical facility – In general, the decision to move the patient out of the home setting for emergency care would be based on the patient's clinical status and any consultations that may be needed. In some cases, the patient's symptoms may be so severe that the decision to transfer the patient is made by the transfusionist. The SOP can be used as a resource to guide decision-making in these cases, but it should not be used as a substitute for clinical judgment; the approach should be patient-specific. (See "General principles of home blood transfusion", section on 'Major transfusion complications'.)
If emergency transport is needed, emergency medical services are optimal; these may include ambulance service or in some cases air ambulance (helicopter). In the United States, these services are accessed by calling 9-1-1. If these services are not available, home transfusions should be avoided in most cases.
Details of the management of transfusion reactions in the home setting and indications for transfer to a hospital or other medical facility are provided separately. (See "General principles of home blood transfusion", section on 'Management of reactions'.)
SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Transfusion and patient blood management".)
INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.
Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)
●Basics topics (see "Patient education: Blood donation (giving blood) (The Basics)")
●Beyond the Basics topics (see "Patient education: Blood donation and transfusion (Beyond the Basics)")
SUMMARY AND RECOMMENDATIONS
●Rationale and general principles – Standard Operating Procedures (SOPs) enhance transfusion safety by creating detailed, standardized documents. The table (table 1) summarizes key SOP components. (See 'Overview' above.)
•The SOP should be based on applicable regulations, standards, and accepted transfusion practices and approved by medical and administrative leadership. (See 'Rationale and purpose' above.)
•Facility-specific input is important to tailor the SOP to the specific circumstances of the facility overseeing the transfusions. (See 'Importance of facility-specific input' above.)
•Companion documents include informed consent, checklists and supplies lists, a transfusion report, and patient instructions. (See 'Companion documents' above.)
•The transfusing entity is responsible for validation, ongoing review, and assuring staff training and compliance with procedures. (See 'Validation, review, and training' above.)
•Citations for other relevant publications are listed above. (See 'Other resources' above.)
●SOP for pretransfusion activities – Pretransfusion activities specified in the SOP should include assessment of the safety and appropriateness of the home site, obtaining informed consent, proper collection and labeling of pretransfusion specimens for testing/crossmatching, determining the appropriateness of specific components, and ordering the correct component(s) and dose(s). (See 'Pretransfusion activities' above.)
●SOP for administering the blood component(s) – The SOP should address transport and storage; components should never be placed in a home refrigerator or unmonitored refrigerator, even in a physician's office, skilled nursing or rehabilitation facility, or other facility refrigerator for storing pharmaceutical products. A two-person document check and bedside clerical check are essential. The SOP should specify the administration tubing, infusion solution, infusion rate, monitoring, and disposal of tubing and needles. (See 'Transfusion administration' above.)
●SOP for managing transfusion reactions – The SOP should contain specific and complete information for recognizing and managing adverse events in the peritransfusion period. Medications to treat transfusion reactions should be listed with method of administration, dose, indications, and whether administration is intended to be done as needed (without approval from the attending physician), such as would apply to epinephrine for anaphylaxis. Possible need for transfer to a hospital or other medical facility should also be addressed. (See 'Management of complications' above.)
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