A colleague in a Rocky Mountain state wants to know if other institutions obtain 'physician signatures' for all uncrossmatched blood products that are dispensed to the emergency room in case a patient needs the blood, even for units that are unused and sent back to the blood bank. She asks this question because while she was reviewing the AABB's Standard Source Questions and Answers regarding AABB Standard 5.18.4 (Urgent Requirement for Blood and Components) she interpreted the discussion to imply that a physician's signature was needed for all uncrossmatched units that are dispensed to the emergency room, even those that are not used.

Her hospital is a level II trauma center where they have established a 2-tierred trauma protocol. In the most emergent situation, the blood bank responds to a specific loudspeaker page and delivers 4 group O Rh negative RBCs in a cooler with ice to the emergency room. In many cases the patient is still being transported to the hospital, so that bringing the blood to the ER is in anticipation of critical need. The units are tagged as emergency units and there is a place for the physician to sign if the units are used. Frequently the units are returned to the blood bank unused. They document in their computer system the date and time the units were issued in the cooler and the return date, time and temperature of the units. If the units meet acceptance criteria they are retagged and returned to the refrigerator to wait for the next time there is a similar page. The inquiring colleague does NOT see why a physician's signature would be needed, unless a unit is actually administered to the patient.

The following comments have been received.

ADDENDA Nov. 16, 2004

1. The Editor points out that AABB Standard 5.18.4 - Urgent Requirement for Blood and Components - states that "the blood bank or transfusion service shall have a process for the provision of blood and components before completion of tests listed in Standards 5.8.4, 5.13.3, and 5.14 when a delay in transfusion could be detrimental to the patient. Standard 5.12 and Standards 7.0 to 7.2 apply". This particular Standard was discussed in the AABB Standards Source 2004 (which is an EXCELLENT resource that can be purchased from AABB) .

In the AABB Standards Source 2004 there are two scenarios discussed that are germane to this discussion. In scenario 1 a blood bank receives a request for uncrossmatched blood from an Emergency Center, the blood is issued, but the patient never arrives and the blood is not used. In the second scenario, a blood bank receives a request for uncrossmatched blood from an emergency center, but the blood never leaves the blood bank. For both scenarios the question posed is "Do we need a physician’s signature on the uncrossmatched form?" According to the discussion in the AABB Standards Source 2004, although the blood was never transfused in the first scenario, because the uncrossmatched blood was actually issued from the blood bank or transfusion service for a "specific" patient, a physician signature is required. In the second scenario, although the uncrossmatched blood was requested, since it was never issued and it never left the blood bank or transfusion service's control, no physician signature is required. The AABB Standards Source 2004 explains that "the 22nd edition of the Standards for Blood Banks and Transfusion Services addresses the urgent requirement for blood and components in Standard 5.18.4. Standard 5.18.4.5 states that records shall contain a signed statement from the requesting physician indicating that the clinical situation was sufficiently urgent to require the release of blood before completion of compatibility testing. These records require a minimum retention time of 5 years. According to Section 6, Documents and Records, under Standard 6.2.3, the record system shall make it possible to trace any unit of blood or component from its source (donor or the collection facility) to final disposition, to review the records applying to the specific component, and to investigate adverse reactions manifested by the recipient." The AABB Standards Source 2004 adds that "in the Code of Federal Regulations, under Title 21 CFR 606.160—Records, number (3) Storage and Distribution Records, item (v) states that "emergency release of blood, including signature of the requesting physician obtained before or after release." The AABB Standards Source 2004 emphasizes that the difference between these two scenarios is that for the first scenario, the blood left the blood bank/transfusion service premises, whereas for the second scenario, it did not. The logic is that the blood bank/transfusion service is required to trace any unit of blood or component from its source to its final disposition. According to the AABB Standards Source 2004 "All blood or blood components requested for release should be "assigned" to an intended recipient before compatibility testing is completed, whether the blood leaves the blood bank or not. When the ordering physician or facility receives the blood, the ordering physician or a representative should sign for the unit, thus accepting responsibility for this product and the reason for the request. If the blood or component is requested before compatibility testing is completed and does not get issued by the blood bank or transfusion service, the situation would be considered a "canceled order." Emergency and Trauma Services should establish policies and procedures for the assessment and monitoring of the emergency provision of blood. The responsibility for review and authority for the disposition should be stated. A retrospective audit to evaluate the appropriateness and urgency of each of these requests may provide beneficial information."

ADDENDA Nov. 17, 2004

2. A colleague in Boston believes that a physician's signature is required whenever uncrossmatched blood is issued from their blood bank, even if the blood is not used. This is because the unit(s) left their control. They report having had problems getting signatures from the Emergency Room physicians. In the past they spent days (sometimes weeks) tracking down physicians' signatures. A series of meetings with the Emergency Room management has resulted in a much more efficient system. They have two pre-prepared sets of blood; 6 group O Rh positive and 2 group O Rh negative units of leukoreduced irradiated red cells, for which the segments are already pulled, and an emergency release form is already completed. When the ER needs the blood they call the blood bank. The blood bank places the units into two coolers: the 6 group O Rh positive units go into one cooler, and the 2 group O Rh negative units go into the other cooler. The cooler containing the group O Rh negative units is colored pink. The emergency release form has two parts. The blue top copies go with the coolers and are conspicuously placed on the outside. The nurse in charge of the patient IMMEDIATELY gets a physician's signature. The emergency room physicians decide whether to use the group O positive and/or the group O negative units. They report that this system has worked well. The continued good relationship with constant communication with the ER has proved successful.

ADDENDA Nov. 22, 2004

3. The inquiring colleague's institution is now considering adopting a policy to enter the name of the ordering physician in their computer whenever blood is issued to the ER but not used. This documentation would be added to the 'unit history' in their computer and there would be no "paper" signature. They wonder if others have taken this approach. If so, has this practice been considered acceptable by inspectors from the AABB, CAP or FDA?

ADDENDA Apr. 13, 2005

4. Editor's note: The discussion in the publication by Weiskopf and colleagues (pdf file) may be of interest to colleagues concerned about rapid provision of blood in an emergency situation.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator