Transfusion of blood and its components is, ordinarily, a safe and temporarily effective way to correct hematologic deficits, but problems do occur. These adverse effects are commonly referred to as Transfusion Reactions. Some adverse effects can be prevented; others cannot. Health care providers should know the risks of blood transfusion and evaluate them against potential therapeutic benefits in light of these risks. In the event of a suspected transfusion reaction, the personnel attending the patient shall immediately notify a responsible physician and the transfusion service. All suspected transfusion reactions shall be evaluated promptly, but the evaluation should not delay proper clinical management of the patient.
II. Clinical Significance: N.A.
Refer to “General Processes, Blood Bank” protocol.
Fresh red cells and serum or plasma (collected with EDTA, heparin or citrate), less than 3 days old is used. Specimens must be stored at 2 - 8°C and be free of hemolysis. Serum separator tubes are unacceptable.
Note: The technologist performing the testing on the patient specimens must confirm that all identifying information on the request form agrees with that on the specimens for blood grouping typing or compatibility testing. This is noted by performing a clerical check.
If needed, two urine voidings from the onset of the reaction are collected by the nursing staff.
2. Refer to appropriate procedures, such as “ABO Group and Rh Type, Patient; MTS Monoclonal Grouping Cards”, “Antibody Detection & Identification; MTS Gel Card”, etc.
Refer to appropriate procedures, such as “ABO Group and Rh Type, Patient; MTS Monoclonal Grouping Cards”, “Antibody Detection & Identification; MTS Gel Card“, etc.
VI. Standardization: N.A.
1. Primary (bedside) Investigation: A tech, or designee, must go to the bedside prepared to obtain a blood specimen and to investigate any possible identification errors.
Note: If possible, all transfusion reaction investigations should be performed by a different tech than the one doing the original crossmatch.
A. The phlebotomist, with the printed requisition, obtains the correct samples and records the clerical checks on the requisition.
If any of the answers to these questions is adverse, the pathologist must be notified immediately.
B. Blood is drawn from the patient with careful attention to specimen/patient identification. (Refer to the protocol for “Patient Identification”.) The preferred specimen is an EDTA tube and a clot tube.
C. A Transfusion Reaction Report form must be started by the nurse in charge of the patient and delivered to the lab as soon as possible. This form is required for clinical recordings.
D. The blood bag as well as the attached transfusion set must be delivered to the lab to hold for possible culture.
E. If needed, the patient's next two urine voidings will be sent to the lab accompanied by laboratory downtime requisitions so no charges are generated on the patient's account.
2. Laboratory Investigation: (Perform as soon as possible). Refer to the “Transfusion Reaction Recording; SafeTrace” procedure.
A. Evaluate the post reaction patient blood specimen for:
a. Color of the serum: Pink or red discoloration (hemolysis) indicates presence of free hemoglobin breakdown products. If present, contact the Pathologist immediately. Use the pretransfusion specimen for comparison.
b. ABO group: The result should be consistent with historical result. If not, contact a Pathologist immediately and type the pretransfusion specimen also.
c. Direct antiglobulin test (DAT): If antibody coats transfused incompatible cells without immediately destroying them, the DAT will be positive with a mixed field appearance. If positive, contact the Pathologist immediately and test the pretransfusion specimen also. (The Pathologist may request that an elution be performed on the EDTA specimen if the DAT is positive postreaction and negative pretransfusion.)
B. If all of the above tests are acceptable:
The Pathologist need not be called. Complete the paper work on the transfusion reaction form and place the completed forms on the Pathologist's desk/tray. The Pathologist will review the paperwork within 24 hours to determine if additional testing is required.
C. If it is determined additional testing is required, follow the Pathologist's instructions that might include the following:
a. Perform the ABO and Rh tests on both the pretransfusion and postreaction patient specimens, and the blood from the donor unit(s). (Refer to “ABO Group and Rh Type, Patient; MTS Monoclonal Grouping Cards” procedure.) If a discrepancy is identified, contact the Pathologist immediately.
b. Perform the antibody screen test on both the pretransfusion and postreaction patient specimens. (Refer to the “Antibody Detection & Identification; MTS Gel Card” procedure.) Contact the Pathologist if the results differ from the pretransfusion work. If either antibody screen is positive, identify the antibody.
c. Perform the crossmatch of the donor unit(s) using both the pretransfusion and postreaction patient's specimens against a sample of blood from the donor unit. (Refer to the “Crossmatch; MTS Gel Card” procedure.) Contact the Pathologist if results differ from the pretransfusion work.
d. Check the urines with a urinalysis dipstick when they arrive in the lab. (Refer to the “Urinalysis, Routine” procedure.) Note the presence of hemoglobin and perform microscopic examination if positive. Look for intact red cells and record their presence or absence. Contact the Pathologist if positive for free hemoglobin.
e. Perform other tests as requested by the Pathologist.
3. When all results are entered into the SafeTrace system and saved, a Preliminary Transfusion Reaction Report form will be printed. This report is given to a Pathologist, who will review the report and suggest additional testing if needed, or sign it off. This must be completed and signed within 24 hours of the occurrence.
4. All paper copies will be retained in a file in the Blood Bank. Formal reporting of the transfusion reaction will be done via the SafeTrace computer system.
VIII. Limitations: N.A.
IX. Results Derivation:
1. Serious adverse reactions in recipients must be reported to the collecting facility. Refer to the Customer Handbook distributed by the blood supplier. These reactions include:
A. Transfusion related fatalities
B. Acute hemolytic transfusion reactions
C. Delayed hemolytic transfusion reactions requiring hospitalization or immediate transfusion
D. TRALI (transfusion related acute lung injury)
E. Graft versus host disease
2. Posttransfusion infections of viral hepatitis (within six months of transfusion), or HTLV-I or HIV (in those individuals not known to have risk factors other than blood transfusion) and any other transfusion-associated infections (malaria, babesiosis, bacterial contamination or infection) are required to be reported to the collecting facility. (See form T-003.) The Pathologist will decide on reporting this and will instruct the blood bank tech to fill out this form. The State Board of Health also requires submission of a form in cases of posttransfusion viral infections.
3. Transfusion related fatalities are reported to the FDA Center for Biologics Evaluation and Research (CBER). The phone number for reporting such incidents is (301) 827-6220. This number can be called 24 hours a day, seven days a week. Initial notifications can also be sent by fax, (301) 443-3874, or e-mail, email@example.com. Initial notifications do not replace the seven-day written report requirement for reporting these incidents (21 CFR 606.170[b]).
4. Transfusion related fatalities must be reported to the Joint Commission. Phone the Sentinel Event hotline at 630-792-3700. Complete the on-line Self-Report form on the Joint Commission home page. ( www.jointcommission.org)
X. Expected Result(s) and/or Critical Values: N.A.
XI. Quality Control: N.A.
1. AABB Standards for Blood Banks and Transfusion Services; current edition.
2. AABB Technical Manual; current edition.
3. MVRBC contact.
i. May 1983 M. English
ii. April 1994 M. Burger
iii. November 1998 B. Lucas (Revised: VII., 2., VIII. 3.added)
iv. February 2002 N. Combs (Revised: III.; IV.; VII.1.A.; Transfusion Rx Checklist)
v. October 2003 M. Burger (Revised: IV.; VII.1,3-4.; IX.1-2.; XII.; format)
vi. February 2007 S. Hosch (Revised: IX.4.)
vii. November 2008 S. Hosch, N. Combs (Revised: VII.2.A-C.; IX.1.E, 2.)
Interim Review: September 2009 S. Hosch (Revised: I.note removed; replaced linked forms)