A colleague in California reports that his transfusion service occasionally receives notices from their blood supplier that say something like the following example:

"Donor X donated blood which was shipped to your hospital. All testing [thank goodness] was normal. Later, the donor returned to donate blood again, but this time he admitted to having had a cosmetic tattoo (showing a picture of his mother) put on his left buttock a week before making the donation that was shipped to your hospital. Had we known about the tattoo at the time of that donation, the donor would have been deferred, and the unit of blood would never have been shipped to your hospital".

The California colleague reports having spoken to representatives of the FDA at CBER to understand the legal obligation that his hospital has to notify the recipient or the recipient's physician when a blood product is recalled due to additional donor information that is discovered during the post-donation period. Based on his discussion with a representative of the FDA, the inquiring colleague is of the opinion that FDA mandates that blood product providers notify consignees of any irregularities in the donor's history that are later discovered, when such additional information would have resulted in the deferral of the donor. However, the inquiring colleague was also led to believe that the FDA does not mandate the consignee (e.g., the hospital transfusion service) to automatically notify the recipient or the recipient's physician when additional history is discovered that disqualifies the donor; such notification is left to the "medical discretion" of the consignee. In some cases the nature of the recall requires (both morally and ethically) the notification of the recipient or the recipient's physician, so that appropriate clinical follow up and testing can take place. In other cases, it might be argued that if the additional donor history does not present a medical risk to the recipient, notification is unnecessary and might cause a recipient to worry needlessly. The inquiring colleague's hospital has adopted a policy that the transfusion service physician reviews each blood recall notice, and notification is based according to the medical risk the recalled product presents to the recipient. This risk assessment is done on a case by case basis. In some instances there is no notification of either the recipient or the recipient's physician. The inquiring colleague wonders how others are addressing this issue.

The following responses were received.

1. A colleague in Texas reports that their hospital transfusion service Medical Director considers each blood product recall on a case by case basis and decides whether notification of the recipient or his/her physician is warranted. In the case of a tattoo like that described by the inquiring colleague from California, the Texas hospital transfusion service medical director would usually decide that it would put undo worry in the mind of the recipient, and no further action would be taken. However the Texan would notify recipients when the donor subsequently tests positive for hepatitis or HIV.

2. A QA/Compliance Officer at a hospital transfusion service in Los Angeles reports that when they receive donor product recall notices from their blood supplier, even though the letter states, "While it has been determined that this history can represent a risk of transmission of a bloodborne pathogen, the risk in this instance is not known. However, the final determination of safety rests with the recipient's physician.", it is their policy for the Medical Director of the Transfusion Service to determine whether notification of the recipient's physician is merited. The few times that their Medical Director has determined that notification should take place occurred with recent malaria risk travel by donors of platelet products transfused within the previous month to immunosuppressed recipients. They do not notify the recipient's physician in the vast majority of recalled product cases. They document the Medical Director's decision and leave it at that.

ADDENDA June 23, 2003

3. A New York colleague reports that his hospital transfusion service is often contacted by their local blood center, if the blood center learns additional information about a blood donor after a blood donation. The New York colleague says that these recalls are a pet peeve for him. In his opinion, recalling units of blood collected and (usually) transfused months or years ago because the donor forgot that he was taking finasteride or had a tattoo in Singapore in 1983 is (in his opinion) a waste of time and effort. He has a simple rule. If he can think of a specific disease that should be tested for or something the patient's doctor should DO, he contacts the patient's physician. If the only likely outcome is more bureaucracy and mounting anxiety without any utility for the patient, they fill out the form, send it back, and file a copy.

4. Dr. Glenn Ramsey of Northwestern University, Evanston, Illinois (attribution used with permission) reports that according to data that he and Dr. Laurence Sherman published in Transfusion (no abstract), about 1 in 2000 available blood components were recalled in 1998 in the US. (Transfusion 40: 253-54, 2000); earlier data Transfusion 39:473, 1999.

These data do not include market withdrawals, which are not published by FDA. The general approach at Dr. Ramsey's institution is that recalls and withdrawals are treated in a similar manner, i.e., the medical director reviews each case. Common problems are discussed at their transfusion committee for concurrence on how to handle them. One other factor to consider is whether the donor has been re-tested as negative long enough after the donation in question, such that a window period has passed for the infectious marker(s) in question. If the patient has expired of underlying disease, they do not pursue anything further, except for HIV lookback to family as required by federal regulations. They notify physicians about donor infection risks such as tattoos, malaria travel exposure, and confirmed viral infections, but not about such things as CJD travel risk (per FDA guidance), donor cancer, donor medications (except if teratogenic drug and pregnant woman was recipient). Dr. Ramsey adds that the FDA has been addressing this issue of post-donation information in their most recent guidance documents on emerging infectious risks such as West Nile, smallpox vaccination, and SARS. For bacterial detection in platelets, the patient's physician is notified for co-components associated with confirmed infections, but not for unconfirmed surrogate markers such as pH and glucose. Dr. Ramsey concludes that this whole area is certainly worthy of further analysis and discussion, and he has written an article on this topic which is scheduled for publication in Jan 2004 Transfusion Medicine Reviews (see reference in item #6 below).

ADDENDA Jan. 23, 2004

5. A medical director of a Transfusion Medicine and Diagnostic Immunology Services in Massachusetts reports that this discussion, addressing a problem that confronts many transfusion medicine specialists in his state, has become more frequent, at least at his institution, in the past few years. In the letter from their regional blood supplier regarding "urgent biological market withdrawals", it is typically stated that "the final determination of the safety of the product and the risk to the recipient does, however, rest with the recipient's physican". The responding physician reports that issues regarding these letters were addressed at a recent meeting of the Medical Advisory Committee of his regional blood supplier. Concerns were voiced about not including hospital transfusion medicine service medical directors in the notification decision process. It was indicated that these directives came from the national organization of the blood supplier but how they were derived was unknown. Clarification from the national organization is currently being pursued. From the discussion it was interesting to note the variation of practice by the individual hospitals. Some places notified recipient physicans on a selective basis after the Transfusion Service Medical Director review of each case, whereas others notified recipients' doctors regardless of the reason for the recall action. With respect to the latter, some individuals were concerned of potentially increased medico-legal risks if they elected not to notify since they had received a letter directing them to do so from a well-recognized national blood banking organization. Additional comments regarding ' blanket notifications' pointed out the potential development in a recipient's physician of "notification fatigue"as well as public relations issues in defense of the blood supplier and blood banking community in general when the notification was judged to be trivial by the recipient's physician. Many also noted the lack of continued contact by these doctors with these patients as well as their inability to re-establish contact with them because of our mobile society. No one disagreed with the need to notify physicans and/or patients, but the development of a consensus notification guidance strategy by transfusion medicine professionals was considered to be potentially useful. The responding physician suggests that "Perhaps physicians involved at blood donor centers and hospital transfusion medicine services through professional organizations could help establish such protocols."

ADDENDA Jan. 29, 2004

6. Editor's Note: Dr. Glenn Ramsey (item #4 above) recently published a review article on the topic and provided his input on procedures to have in place for managing these types of retrievals and notifying physicians (Transfusion Medicine Reviews 2004;18:36-45). I think hospital transfusion service physicians and others might find this article to be useful.

Please submit comments to the e-Network Forum.

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