In spite of repeated assurances by blood-collecting organizations, the U.S. Food and Drug Administration (FDA), and the scientific and expert community regarding the safety of the blood supply, the public's fear of receiving blood transfusions has increased dramatically over the last few years (1). When faced with the prospect of a transfusion of any type of blood component, many patients become extremely apprehensive. They expect and demand absolute warranties about the quality of the blood intended for transfusion. They start looking for, requesting, and demanding alternatives such as autologous deposits. If such alternatives are not logistically feasible, patients and their relatives then usually begin seeking out and identifying potential directed/designated blood donors (DDDs). In the minds of the patient and the immediate family, this alternative may be "safer" than receiving the blood of unknown people who frequently and voluntarily donate to the blood banks of a community.
These are perceptions and fears that patients and family members often cling to with an almost religious conviction. Unfortunately, they also tend to obscure several crucial questions that surround the issue of DDD donations, namely, confidentiality, adherence to accepted blood-banking and FDA guidelines, and legal liability, and cannot be further from scientific reality (2) and the truth.
DDDs: A Familiar Issue
In practice, the blood-banking community is familiar with the issue of DDDs. For years, it has had sufficient resources and controls to ensure minimal risks for the DDD blood recipient, appropriate protection of confidentiality for the DDD, and adequate selectivity among DDDs. For instance, DDD donations have been used in transfusion medicine for many years as specific therapy for recipients of renal transplants, specially selected platelet donors, and donors with rare RBC phenotypes (3). But, in the past, the demand for DDD donations was not very great. However, with the advent of the problem of blood-borne transmission of the acquired immunodeficiency syndrome (AIDS)-related virus, the public lost confidence in the blood-banking system's ability to ensure the safety of transfusions in general and increasingly turned to DDDs as a "safer" alternative. Consequently, in response to the greater demands of the public and to pressure from patients, we and many other blood banks in the country were forced to develop more sophisticated DDD programs.
Blood banks such as ours at M. D. Anderson Cancer Center have implemented procedures and a logistical process to screen, draw, test, store, and transfuse to the intended recipient DDD blood. The establishment of such a complicated program has demanded that we and others devise a totally segregated record-keeping system for monitoring the whole DDD donation process from initial donor contact to final disposition of the unit of blood.
The Problem of Confidentiality
The DDD is that person selected by the patient and/or the patient's family, often for unclear and, at times, convoluted and contrived reasons, to be the "safe blood donor" for a given potential transfusion for the patient (4). However, while the DDD's being well known to and chosen by the patient and patient's family helps allay their fears about blood transfusions, it also unfortunately gives rise to problems of confidentiality. DDDs pressured into donating by patients and their relatives elect at times to hold back pertinent information that may disqualify them from donation. In many instances, these DDDs fail or elect not to disclose to their recruiters facts or events in their past lives or health conditions or life-styles that may be an embarrassment to the DDD and his or her family and friends. It is not uncommon to see the DDD accompanied through the screening interviews by the patient, who then closely shepherds and monitors the DDD during the whole screening process. The DDD is thus sometimes inhibited from providing the blood-collecting organization with a truthful and unbiased medical history and with critically relevant information that may contribute to the decision to accept or reject the donor, a decision made based on regulations of the FDA, other accrediting organizations, and the blood-collecting agency and on community screening standards (5).
The problem of confidentiality arises again once the DDD is allowed to proceed with the blood donation. At that point, members of the patient's family or the patient himself will often record the donor's unique number assigned by the blood-collecting agency so as to be able later to monitor the use of the DDD's donated unit when a transfusion is indicated and ordered by the attending physician. Consequently, if a unit is rejected for use, the patient or patient's family may seek to find out why. This prying into the DDD's confidentiality can potentially bring problems for the DDD, about whom very intimate and confidential information may thus be released. In effect, DDDs turn over to the patient and the surrounding family vital information that the blood-collecting agency would never divulge or share without the donor's specific written authorization.
Furthermore, DDDs and the intended recipients consider a unit of DDD blood their property. Therefore, they and/or the recipients' families carefully and regularly monitor the DDD blood inventory. For instance, a patient or family members may frequently phone our transfusion service to inquire about the status of each unit of DDD blood or to have our personnel confirm in our computer data bases the availability of such units. When the patient and family demand to know the results of FDA-required testing, this creates for our personnel considerable conflicts with the patients and their relatives and ethical nightmares. In addition, the DDD blood recipient, family, or both quite often attempt to trade or "donate" the DDD units to other patients they have befriended during the patient's stay in the hospital; this creates misunderstanding and anger among both parties when we inform them this cannot be done for reasons of both safety and confidentiality.
The DDDs themselves, their spouses, or their significant others, when learning that DDD units are not available for transfusion for reasons not readily apparent, often generate frantic calls to our transfusion service demanding to know the reason for the unavailability of a given unit of blood. These calls are placed at all times of the day or night and on all days of the week, and most are unfriendly in tone.
To make matters worse, the distress and anguish that the DDDs undergo while trying to find out why a given unit of their donated blood is unavailable is often heartrending for all concerned. This has led us to devise a system for rapidly conveying to DDDs the real reasons for the unavailability so as to avoid unnecessary mental suffering on their part. This program, however, requires a substantial investment of personnel time to search out the pertinent information, to ensure that the person we are talking to is the true DDD, and to spend sometimes long periods on the phone explaining to, at times, uninformed persons the meaning of a false-positive result for one of the many FDA-required tests, even before confirmatory testing is completed. In addition, our staff must sometimes endure insults, threats, and other forms of harassment in dealing with these DDDs.
The Problem of Unsuitable Donated Blood
Several studies have clearly demonstrated that DDD donation may have inherent dangers. As we briefly touched on earlier, one is that the donors may not answer truthfully very probing and discriminating questions about life-styles that may, in compliance with the FDA requirements, preclude blood donations (6). For instance, in some cases at our institution, DDDs go ahead and donate and then call us after they have donated to instruct us not to use their blood for reasons that they do not wish to discuss or explain. After this information is received, the blood bank is saddled with the task of having to explain to irate patients and families why a unit of blood donated by one of their "specially selected donors" is not available for transfusion. The ethical problem faced by the blood bank is readily apparent. Needless to say, such a unit of blood is quickly discarded.
The Problem of Legal Ramifications
The transfusion of DDD blood is not an inconsequential event, since it can and, in some cases, does produce bad outcomes, e.g., disease transmission, and potential legal liabilities. A recently tried case is a good example (7): A patient was advised by a nurse at a New York hospital to use DDD blood instead of blood from the hospital's blood bank inventory. The patient subsequently had a DDD blood transfusion and developed posttransfusion AIDS because one of the DDDs had a high-risk life-style and had not disclosed it at the time of donation. The patient sued the hospital and won a sizable award by arguing that the hospital and its staff were promoting an unsafe practice and that he should have been advised about and discouraged from using DDD blood. The potential legal liabilities affecting the issue of DDDs, as apparent from this example, suggest that the physician and other care extenders would be prudent in not advising the patient and family to recruit DDDs. We observe quite frequently in our own institution notes written in patients' charts recommending the use of DDDs. This, we think, could open the door to future requests for legal redress by patients and/or their families if a bad outcome, e.g., disease transmission, occurs.
It is our belief and recommendation that it be left to the patient and/or family to bring up the issue of DDDs, and if they do, that they be referred to the professional staff of the Section of Transfusion Medicine and that this be documented in the chart. We routinely inform those interested patients and families of the advantages and disadvantages of DDDs and other alternatives and document this in the patients' charts.
DDD Practices at M. D. Anderson
At M. D. Anderson's blood bank, we have adopted a policy specifically designed to provide the patient requesting DDD blood with peace of mind and with simplified access to this type of allogeneic blood alternative without violating either the DDD's confidentiality or any of the FDA-established requirements for such donations. Nevertheless, we are still constantly asked by DDDs to bend or ignore FDA requirements just to accommodate them.
Our determined adherence to community and FDA standards has allowed us to avoid drawing blood from unqualified donors. Once it has passed all FDA-required tests, DDD blood is kept for 42 days in storage. DDD blood not used by the intended patient is not crossed over for use by other patients, although as we have stated, relatives in the waiting rooms often try to swap or "donate" DDD blood units. Again, such arranged transfers are not allowed, and explaining this to a well-meaning public unfamiliar with blood-banking regulations demands a heavy commitment of time by blood bank personnel. It should be clear that DDD activities require a substantial investment of resources from the moment that the DDD shows up to donate until the final disposition of the unit of blood. Fortunately, however, DDD activities and blood units represent a very small part of our business and our blood inventory, respectively (Table 1).
|Total DDD units drawn||1,485|
|DDD units found to be unfit for transfusion||69||4.6%|
|DDD units put into 'Special DDD Inventory'||1,416||95.3%|
|DDD units transfused||881||59.3%|
|DDD units not transfused that expired in storage||535||36.0%|
|*||The data shown deal only with the DDDs who were not rejected at the initial screening; to include data for rejected DDDs would add another 15-20% to the number of DDD blood units drawn. For the same period covered by this table, we transfused 30,771 units of blood from allogeneic, non-DDD sources.|
Further, as stated above, we have devised a policy that leaves it up to the patient and/or the patient's family to broach the idea of DDD blood transfusion. This lessens our institution's chances of being sued in the case of a bad outcome in patients receiving DDD blood. It also clearly places the responsibility for choosing or not choosing DDD transfusion with the patient.
Implications for the Future
Undoubtedly, interest in DDD blood donation and its popularity have grown out of the public's mistrust and fear of the safety of traditional donor acquisition programs. At the same time, the transfusion medicine community is being challenged and wrongly maligned as never before by the repercussions of AIDS and the blood-borne transmission of hepatitis B, hepatitis C, and other viral, bacterial, and parasitic diseases. Many blood banks and blood centers have had to adopt and implement DDD programs under pressure from a not very informed public. Other blood-collecting organizations, having seized this opportunity to capitalize on the public's fears, have instead launched slick advertising campaigns that serve only to improve their financial bottom line (6).
It is clear that DDD programs have more disadvantages than advantages. Numerous publications, along with our own experiences and those of other reputable academically based blood-collecting organizations, show that DDD donations have no proven medical value and that the DDD issue is mired in administrative, legal, and ethical bogs that only help to further polarize the public from and create mistrust towards the blood-banking community at large (6). The existence of DDD programs may also have a significant negative impact on the volunteer blood supply of a region. For instance, donors who ordinarily participate in volunteer community blood programs may withdraw from donating, holding out instead for the possibility that a friend or relative may need them as a DDD.
Among other things, it is our obligation in the transfusion medicine community to develop safe transfusion strategies, to drastically reduce the use of allogeneic blood products no matter how apparently safe the blood supply may be, to increase the use of autologous blood where its use may be indicated, and to better use pharmacologic agents that may prevent bleeding in different clinical situations. In light of these aims, allowing the continued existence of DDD programs and practices serves only to misguide the patient in particular and the public in general and to engender in them a false sense of security and complacency.
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