This section will discuss standards related to issuing blood from the transfusion service laboratory, particularly to the operating room (OR). The discussion is not meant to be definitive or all inclusive.
Standards related to issuing blood from its temperature-controlled refrigerator in the TS to patients on the wards, in operating rooms, etc., include many requirements, e.g., standards for
- incompletely tested products
Applicable standards and regulations for this case include:
CSTM Standards - Canada (related CSA Standard Z902-04 in brackets):
K4.0.Administration of Red Cells
L4.1. Administration of red cells should be completed within four hours of the time of issue from a temperature-controlled environment. (CSA 11.4.6)
K6.0.Reissuing Blood and Blood Products
K6.1. Blood and blood products may be reissued if:
a. correct storage conditions, as defined by the supplier and applicable standards, have been maintained and documented
b. the bag is intact
c. at least one sealed segment of integral donor tubing is attached
d. documentation to indicate that it is being reissued and has been visually inspected (CSA10.10.4)
K6.2.Blood shall not be returned to inventory or reissued if they have been at room temperature or in an uncontrolled environment for longer than 30 minutes. (CSA 10.10.4; 11.4.7)
Similar standards exist in other countries.
Normally the laboratory would issue only one RBC at a time, but this policy was not documented. In this case, because emergency blood was ordered for two patients who were severely hemorrhaging, laboratory staff issued all RBC at once:
- 3 A Rh positive RBC for JS were sent to the OR (and transfused within one hour)
- 2 O Rh negative RBC for the female patientwere sent to the OR
The OR did not have a temperature-controlled refrigerator. The O Rh negative RBC were left on a counter in the OR, and after the patient died, were returned to the laboratory and entered back into inventory. The RBC had been at RT for approximately one hour. Shortly thereafter, both O Rh negative RBC were re-issued and transfused to JS.
Entering the O Rh negative RBC back into inventory after 1 hour at RT contravened CSTM Standard K6.2, but not L4.1 since transfusion was completed within 4 hours. Given that blood was urgently needed, if consulted, it is possible that a physician may have assessed the risks versus the benefits and approved using the RBC.
- Standards that require transfusing RBC within 4 hours andnot returning units to inventory and reissuing if they have been in an uncontrolled environment for more than 30 minutes were established to ensure the efficacy of the blood component and to prevent bacterial contamination.
- Since transfusion of bacterially contaminated blood products is often fatal, TS must do everything possible to ensure that products are maintained at appropriate temperatures and transfused within specified time limits.
- Some best practices are not specified in standards but logically follow from them and should be built into SOPs.
- For example, if transfusion of a unit of blood is to be completed within 4 hours of leaving a temperature-controlled environment, it follows that ?if blood is to be kept at RT before transfusion because the ward does not have a temperature-controlled refrigerator ?only a volume of blood that could normally be transfused within 4 hours should be issued from the TS, typically 1 RBC at a time for patients who are not profusely bleeding.
- If 2 lines are available for the patient, 2 units can be issued at once.
1. After being issued from a temperature-controlled environment, blood must be transfused within:
- 30 minutes
- 1 hour
- 4 hours
- 24 hours
2. Blood can be returned to inventory or reissued if they have been at room temperature or in an uncontrolled environment for no longer than:
- 30 minutes
- 1 hour
- 4 hours
- 24 hours
3. What are the rationales for why blood must be kept in a temperature-controlled environment and transfused within a specified time limit?
- Part 1: Use of historical blood groups
- Part 2. Issuing blood to the OR <--You are here
- Part 3. Medical consultation
- Part 4: Transfusion-related responsibilities
- Part 5: Training and competency assessment
Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev 2005 Jan; 18(1):195?204.
Kuehnert MJ, Roth VR, Haley NR, Gregory KR, Elder KV, Schreiber GB, et al. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion 2001 Dec;41(12):1493-9.