A colleague in Maine reports that their nuclear medicine department is performing Indium 111 WBC studies which involve the removal of 40 cc of whole blood from a patient, labeling white cells, and reinjecting the labeled material back into the same patient. They send the patient’s blood sample to a local reference laboratory where the blood is spun down, the buffy coat removed, and the white cells radioactively labeled. The white cells are then "reinjected" into the patient and tracked to locate sources of infection within the patient. She wonders is this procedure considered a transfusion and if so, does any transfusion service track or regulate this procedure? She acknowledges that their nuclear medicine department has excellent procedures and processes for patient and specimen identification when a nuclear medicine procedure requires the injection of a radiolabeled blood sample. Patients are initially given a hospital wristband (name, medical record number, date of birth and ordering physician). When the blood is drawn, the patient is issued a Typenex band, which is labeled after verbal confirmation of identity. A label from the band is applied to the sample. When the radioactively labeled specimen is returned, the Typenex label is verified against the Typenex band the patient is wearing, and to the hospital band the patient is wearing. A second employee verifies this process. If any discrepancy is found, the "re-injection" is cancelled.

The following comments have been received:

ADDENDA Nov. 8, 2006

1. A colleague in New York State reports that their Department of Health regulates Reinfusion procedures.

She reports that according to the NEW YORK STATE BLOOD BANK REGULATIONS SUBPART 58-2, 10NYCRR - 58-2.27 Reinfusion procedures:

(a) All reinfusion procedures shall comply with written protocols approved by the director of transfusion services and the transfusion committee of the facility where the reinfusion is to be performed, the director of the hospital department where the product is reinfused, and the hospital department or facility where processing for the reinfusion procedure is performed, if different. These protocols shall include procedures for collection, labeling, handling, processing and reinfusion of the product.

(b) All reinfusion procedures performed in hospitals shall be reviewed by the hospital transfusion committee. Out-of-hospital reinfusion procedures shall be performed only by a limited reinfusion service which meets the standards in this Subpart and has been approved by the department.

(c) The syringe, tube, bag, or other container into which the blood or component thereof is collected for reinfusion, shall be labeled at the time of collection with two forms of identification, one of which shall be the patient's name. The person drawing the blood or component shall initial or sign the records pertaining to the collection and certify that the identification on the blood or component and on the pertinent records is correct.

(d) During shipment, processing and storage, reinfusion products shall be maintained at a temperature between one and 38 degrees Celsius, except as otherwise required in a protocol approved by the director of the service performing the reinfusion. Red cell reinfusion products shall not be exposed to a temperature above six degrees Celsius for more than six hours. While in transit, the container and shipping box for such products shall be appropriately labeled as containing human blood products.

(e) Any container into which the blood or component is transferred from another container during reinfusion processing shall be labeled prior to the transfer with two forms of identification, one of which shall be the patient's name or identification code. The person performing the transfer shall initial or sign the records pertaining to reinfusion processing of the blood or component and shall certify that the container identification was transcribed correctly. All final containers shall be labeled with the patient's name, description of the contents, expiration date and dosage, if applicable.

(f) All facilities preparing reinfusion products shall hold a valid department permit in the category of blood services - transfusion. Such facilities shall be open for inspection by the department during normal business hours and shall allow representatives of the department access to all protocols and records pertinent to reinfusion procedures performed in New York State.

(g) No reinfusion of a processed product shall be performed unless two individuals other than the patient have confirmed the identity of the recipient and the product to be reinfused as matching in name and in at least one additional identifier. This confirmation shall be documented in writing.

(h) All errors or accidents during processing or reinfusion procedures, which may pose a substantial risk to the patient, shall be reported to the department's Wadsworth Center, with sufficient detail to facilitate evaluation and investigation, within seven calendar days of the error or accident, or its discovery.

(i) All records pertaining to reinfusion procedures shall be retained for a minimum of seven years.

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Ira A. Shulman, MD
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W. Tait Stevens, MD
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