A blood banker is curious how colleagues interpret AABB Standard 5.17.4.5 (21st edition) which states: "5.17.4.5 - The records shall contain a signed statement of the requesting physician indicating that the clinical situation was sufficiently urgent to require release of blood before completion of compatibility testing or infectious disease testing". The inquiring blood banker wants to know if this means that ONLY A PHYSICIAN SIGNATURE IS ACCEPTABLE? Can an ‘Emergency Release’ request be signed by an RN or other individual? How do trauma centers handle the documentation for emergency release of blood?

In reply to the above question, the following responses were submitted

1. A blood banker in Texas reports that at her facility two people can witness a doctor's verbal order and sign for him/her. In addition, in an emergency, the hospital does not require a physician signature at the time they give out the blood, but leave the form for the physician to sign when the crisis is over and he/she has time for the paperwork. The Texan reports that this is one area where they have found that having ‘paper’ accompany the emergency released blood products ‘works’ better than using a computer emergency issue. Attached is an MS Word file of their Emergency Release Form. The top three lines of their form can be blank when the form accompanies the blood to the site of urgent blood need.

ADDENDA Nov. 27, 2002

2. A blood banker from a 'Sunbelt' state reports that at her Level I Trauma Center, all uncrossmatched units of RBCs have a 'manual' form attached for the physician to sign at the time blood is given to the patient, or after the crisis is over. The patient's name and identification number are added to this form at the time of transfusion. If a patient's name and number are known and blood can be "issued" in the computer first, the form printed is the same as the 'manual' form mentioned above, except that the patient's name and number are printed on it. The emergency release forms have a statement disclosing that the blood is uncrossmatched and a space for the physician's signature. The form is 2 part - the top copy is placed into the medical record and the second copy is returned to the blood bank. This level 1 trauma center also sends blood out on a helicopter with the aforementioned forms attached. They report having had good compliance with their system of documentation.

3. A blood banker in Boston reports that at their facility they issue blood on emergency release at the verbal request of a physician. They require that the requesting physician sign an emergency release form. However, as a practical matter, this form is usually signed by the physician AFTER the fact, sometimes days later. Their residents spend a substantial amount of time tracking down some signatures. In the event that blood products need to be issued for transfusion before antibody work is completed, a blood bank physician signs the emergency release form.

ADDENDA Dec. 5, 2002

4. A blood banker in Louisiana reports that at her Level 1 trauma center, the emergency department faxes an emergency release form with an assigned name, medical record number, and blood bank armband number recorded that will be placed with the patient when the ambulance arrives. The blood bank prepares the blood product units which arrive in the emergency department at about the same time as the ambulance with the patient. If the doctor decides to use the blood, he/she can sign for it, or if too busy signatures are obtained later. Since the facility is a teaching hospital, there is always at least one emergency room staff physician and a trauma surgeon as well as a couple of upper level residents who are all allowed to sign the emergency release, so it is not difficult to get a signature immediately. The responding blood banker reports that a few years ago they were cited by FDA for allowing RN's to sign for the physician, and as a consequence, they no longer allow RN's to sign an emergency release for blood.

ADDENDA Dec. 13, 2002

5. An employee of the FDA has provided the following information regarding emergency release of blood products for the e-network forum to consider: 21 CFR 606.160 (3)(v) states the storage and distribution records requirement: ("Emergency release of blood, including signature of requesting physician obtained before or after release.")

Editor's Comment: From this language it appears that in the situations described above, it is acceptable for the physician to sign the record after release of the product.)

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