Conference Report
Blood donor deferral registries: highlights of a conference B.J. GROSSMAN AND K.M. SPRINGER GUESTEDITOR:T.F. ZUCK
How effective is the DDR in providing information about donors? What regulatory issues are related to the DDR? What ethical issues are related to the DDR? What legal issues are associated with the DDR? Highlights of the symposium are summarized below. The source materials for this summary are the authors’ (BJG and KMS) written notes and audiotapes of the conference. Each speaker reviewed that portion of the text in which his or her presentation was discussed.
THEDONOR DEFERRAL REGISTRY (DDR) is a file containing identifying information about blood donors who may have been disqualified from donating blood because of positive test results for a transmissible disease or an answer given in response to a health history question, or who have been implicated in a case of posttransfusion hepatitis or other infection. Some form of a DDR is required by the Code of Federal Regulations, which states, “A record shall be available from which unsuitable donors may be identified so that products [i.e., components] from such individuals will not be distributed.”’ The DDR is one of several measures used by blood banks to prevent the transfusion of unsafe blood. The DDR was originally conceived as a preventive means of improving the safety of the blood supply. During the early 1970s, blood banking organizations typically kept track of donors who had a history of hepatitis or who had positive test results for the hepatitis B surface antigen (HBsAg). Since the mid-l980s, when it became apparent that human immunodeficiency virus type 1 (HIV1) could be spread by a blood transfusion from an infected individual, the donor deferral categories have increased in quantity and complexity. With these increases, a variety of operational, legal, and ethical issues have surfaced. On July 17, 1991, the American Red Cross (ARC) convened a l-day symposium on blood donor deferral registries. The purpose of the meeting was to bring together for an open discussion representatives of those organizations that have a specific interest in DDR issues. Those attending the conference included physicians, ethicists, lawyers, and other persons interested in blood banking and transfusion medicine issues. The group considered the following questions: What role should the DDR play in protecting the safety of the blood supply? 0 How is the DDR being used in various blood banking organizations?
What Role Should the DDR Play in Protecting the Safety of the Blood Supply? Gerald V. Quinnan, MD, Acting Director of the Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), explained that the FDA places great importance on resolving DDR issues, even though current blood banking practices in the United States are probably the best in the world. According to Quinnan, 998 of every 1000 HIV-l-infected donors are detected by the current methods of donor health history screening, testing, confidential unit exclusion forms, and other deferral methods. The DDR plays a critical role in protecting the safety of the blood supply. Because blood banking organizations do not have a mechanism for sharing the names of deferred donors, it is possible for a donor to be deferred by one blood center and then to walk across the street and be accepted by another. Quinnan expressed a need for linkages between the different DDRs to make them ultimately effective. Robert Westphal, MD, Senior Principal Officer of the Vermont-New Hampshire Region of the ARC, discussed the changing indications for listing donors in the ARC DDR. The DDR initially protected the blood supply by deferring only those donors with positive test results for HBsAg; today’s DDR categories are more numerous and complex. Some donors who pose little harm to recipients are listed. For example, some organizations defer donors with elevated levels of alanine aminotransferase for an indefinite period of time. However, elevated levels of alanine aminotransferase may be caused by noninfectious factors, such as obesity, alcohol, exercise, and many drugs. Westphal stressed the importance of maintaining our perspective on what the DDR is supposed to accomplish. He recommended limiting the scope to recognized
Abbreviations: ABRA = American Blood Resources Associstion; ARC = Americsn Red Cross; DDR = donor deferral registry; FDA = Food and Drug Administration; HBsAg = hepstitis B surface sntigen; HIV-1 = human immunodeflciency virus type 1; NYBC = New York Blood Center. From the American Red Cross, National Headquarters, Washington, D.C. Rcccived for publication November 4, 1991; rcvision rcceived March 9, 1992, and acceptcd April 20, 1992.
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and measurable benefits to the recipients. In particular, he recommended using the DDR only to prevent the transmission of infectious diseases, not to list people who were taking medications or who had a history of cancer. In addition, he expressed a need to find a way to remove from the DDR those donors who are not potentially harmful to recipients of blood transfusions. Westphal believes the DDR needs a trap door to let the “innocent” people out. How is the DDR Being Used in Various Blood Banking Organizations? All blood banks use some form of a DDR as a means of tracking blood donors whose blood may not be safe for transfusion. Although blood banks may vary in the use and operation of their DDRs, there typically are several key features held in common. Five different DDRs were described at this meeting. The registries Ritchard Cable, MD, Medical Director of the Connecticut Region of the ARC, explained that the ARC has used a DDR since the early 1970s to identify donors who had a positive test result for HBsAg or had a history of hepatitis. Donors implicated in cases of posttransfusion hepatitis were added later. ARC blood centers currently screen donors against both a local DDR and an ARC national DDR. As of July 1991, the ARC national DDR contained approximately 250,000 names in 23 different deferral categories, including donors with positive test results for certain transfusion-transmissible diseases; donors with health histories or physical findings that suggest that the individual represents a high risk for transmitting certain transfusion-transmissible diseases; or donors under surveillance after being implicated in a single case of posttransfusion hepatitis. Local ARC DDRs track approximately 1 million additional names. These donors are listed for similar reasons as are the national DDR donors: however, the risks of transfusion-transmissible diseases are considered to be less. These 1.25 million names represent approximately 2 percent of the eligible donor population in the area covered by ARC blood centers. Kathleen Sazama, MD, JD, Associate Medical Director of the Sacramento (CA) Medical Foundation Center for Blood Research, reminded the conference attendees of the numerous categories into which donors are currently deferred according to the American Association Blood Banks standards.2 She then described the California state DDR that was created for hepatitis reporting by the legislature in 1975 and that was implemented the following year. Reporting in two categories was mandated: 1) donors who were seropositive (with or without confirmation), as reported by blood and plasma centers,
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and 2) patients with actual or suspected disease, as reported by hospitals, clinics, and physicians. When disease was suspected or determined to be due to transfusiontransmitted hepatitis, donors were also categorized separately as the sole donor or as one of several donors implicated in the transmission. Similar reporting of HIV1 was mandated legislatively in 1987, and the system retained the stratification of donors versus patients and eliminated the requirement for reporting the name of the test or the disease. In giving examples of the problems with the California DDR, Sazama noted that, as of February 1991, more than 169,000 names had been listed in four categories. Numerous duplicate, incomplete, inappropriate, and inaccurate entries make the system cumbersome and difficult to use. For example, the Sacramento Medical Foundation reported more than 350 donors but identified only 220 true “hits” between March 1, 1985, and February 28, 1991. The data are less useful than originally intended, in large part because of the differential reporting of disease by other health care entities and of seropositivity by blood and plasma centers. Dennis Harpool, Technical Consultant for Blood Systems, Inc., explained that Blood Systems’ blood centers are connected to a central computer system, and all centers currently check the donor’s name against the DDR after the donation is made. However, they are investigating the results of a pilot project in which the donor’s name is checked against the DDR before the donation is made. Blood Systems, Inc.’s DDR contains a list of all permanently and temporarily deferred donors. In addition to current listings, their computer maintains records of past DDR entries that may have been re-entered into the file of suitable donors. Another feature that Harpool described was the ability of the computer to prevent the release of a component still in inventory if a donor returns and is now unsuitable as a donor. In the future, their computer will also be able to keep track of the time limits for temporarily deferred donors. James Reilly, Vice President of Governmental Affairs of the American Blood Resources Association (ABRA), stated that the association’s members, which include plasma fractionators, have their own individual nationwide DDRs. ABRA is developing a single national DDR that would supplement and potentially replace these individual nationwide DDRs. ABRA’s DDR will be limited to donors with positive marker tests. Plasma collection facilities would be able to call a toll-free number from a touch-tone phone and to enter donor information, which is then screened against the DDR. Harold Kaplan, Senior Vice President for Medical Affairs of the New York Blood Center (NYBC), presented information about the NYBC’s DDR. Their DDR can be accessed from a personal or laptop computer at fixed sites, at mobiles, or in
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the laboratory. NYBC’s DDR is also provided to area hospitals. Donor identification Each speaker described donor identification problems. The absence of a single, recognized form of blood donor identification has posed significant problems within the DDR system. Most representatives reported that their institution’s DDR identifies donors by name, social security number, address, date of birth, and/or other types of information. However, because no positive donor identification is required at the time of donation, the information obtained is dependent on the donor’s provision of identical information at each donation. Thomas Zuck, MD, President of the Council of Community Blood Centers and Director of Hoxworth Blood Center, noted that misidentification is a serious problem and leads to duplicate records. If duplicate records are made and if, on the subsequent donation, the test results and health history are acceptable, a previously deferred donor could potentially be deemed suitable for donation. Zuck described a newly developed computer program that compares new entries to previous entries and calculates a score based on similarities in the entries. The purpose of this program is to capture “near matches” and to permit their resolution before the release of the unit of blood. Zuck explained that this system has been used successfully in capturing many duplicated records. Confidentiality Confidentiality is another important component in any DDR. Each DDR presented had some means of protecting the confidentiality of the information it contained. A very limited number of staff members are able to access the DDR, and unique passwords for individual staffers are used. In addition, the California DDR and the NYBC DDR do not list the reason for the entry into the DDR. The NYBC DDR also uses an encrypted data base. How Effective is the DDR in Providing Information About Donors? Operational information William Sherwood, MD, Senior Principal Officer of the Penn-Jersey Region of the ARC, stated that, although the DDR has been regarded as a measure by which to increase the safety of the blood supply, no definitive studies can be or have been performed to establish its efficacy. To do so would require transfusing units now regarded as unsafe, and that would not be acceptable. As an indirect method of measuring the value of the DDR, Sherwood described a study in progress in six ARC regions. The study compares the number of positive test results for infectious diseases in donors who
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have previously been notified that they are unsuitable donors with the number of positive test results in all volunteer donors and first-time volunteer donors during the same period of time. A remarkably large number of donors who have been notified that they are no longer eligible to donate return to do exactly that. Of more than 600,000 units studied, over 5000 (0.76%) were donated by previously deferred donors. Using data from this study, Sherwood showed that, although a significant number of unsuitable donors were intercepted through the DDR screening mechanisms, some categories of deferred donors had no increase in viral marker rates, which suggests that those donors are no less safe than the randomdonor population. In addition, a very small number of deferred donors from outside the region donated, which suggests a very limited value for the proposed national DDR. Research information Roger Dodd, PhD, Head of the Transmissible Diseases Laboratory of the Holland Laboratory of the ARC, pointed out that the DDR has distinct advantages and disadvantages as an aid to research. Some advantages are: that it is a single file of information; that it contains information about a large number of donors; and that it is automated and thus compatible with other electronic data systems. Some disadvantages to using the DDR as a research tool are: that its use may threaten the confidentiality of the information about the donor; that there is a lack of consistency in donor entries; that the true denominator is unknown; that there are no controls for comparison; and that it does not reflect the general population. Dodd pointed out that, despite these disadvantages, the DDR lends itself quite well to a variety of research, including operational evaluations, demographics in targeted populations, trends in deferral rates, and outcomes of diseases. For example, Dodd reviewed a previous study that showed that those donors with a positive test for HBsAg were more likely to die of liverrelated illnesses than were control donor^.^ Dodd suggested that the DDR could be used to help the blood industry understand the outcome in donors with positive test results for antibody to human T-lymphotropic virus type I or I1 or hepatitis C virus. Because outcome studies require some form of identification, which could interfere with the confidentiality of the file, Dodd proposed alternative methods to using the DDR to obtain this information. These included developing a prospective DDR of a target group of donors who have given consent or using unlinked demographics with a local data base. What Regulatory Issues Are Related to the DDR? According to Boyd Fogle, Director of the Division of Inspections and Surveillance of the FDA, one of the
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biggest problems FDA regulators identify in blood centers is the failure to control the proper disposition of unsuitable units of blood and blood components. The largest number of these unsuitable units is obtained from donors who should have been permanently or temporarily deferred because of health history or previous test results. Fogle noted that the number of blood component recalls has increased 150 to 200 percent since 1988, while only 33 percent of all error and accident reports submitted to the FDA have been related to the DDR. Recent FDA inspections have focused on how blood centers maintain control over their computer systems, how well they follow their own standard operating procedures, and how well they control the release of unsuitable units. Fogle said that the most common errors associated with the DDR during regulatory inspections are data entry errors, failure to follow standard operating procedures, inability to track multiple deferral codes, unauthorized changes in the DDR, lack of validation of computer systems, lack of manual backup for computer systems, duplicate record entry, and incomplete records. The FDA considers whether these errors occurred as an isolated event or as a recurring, systemic problem. The FDA evaluates the DDR in relation to testing, component labeling, and component release systems. In particular, the inspectors assess whether the error is one that represents a danger to health. Fogle emphasized the importance of planning and proper design. He noted that FDA is evaluating blood center systems to determine if they are operating under the proper controls. The FDA expects audit programs, with frequent reviews to ensure control over the system. The inspectors check the way that errors are investigated and corrected and evaluate the controls that have been established locally as well as in associated establishments. They ask questions. What are the prospects for the future? What preventive controls have been established to ensure that unsuitable blood components are not released? After considering the answers to these questions, the FDA will determine what regulatory action is appropriate. What Ethical Issues Are Related to the DDR? Arthur Caplan, PhD, Director of the Center for Biomedical Ethics at the University of Minnesota, provided a view of the ethical issues at stake in connection with the DDR. According to Caplan, the DDR promotes the goal of reducing the transmission of infectious diseases. However, rather than adding those deferred or “disqualified” donors to the list, it would be better actually to discourage these donors from giving blood again. Caplan pointed out problems in connection with receiving informed consent from donors. He noted that some of the notification letters and other materials in-
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forming the donor of the criteria for entry into the DDR are inadequate, because they are too technical to be understood easily by most blood donors. He stated that all notification letters should, at a minimum, have information about why the donor is being disqualified and what the options are for counseling. LouAnne Kennedy, PhD, Vice President of Academic Affairs at Kean College of New Jersey (Union, NJ), reiterated the importance of understandable notification materials. Many speakers, including Caplan and George Annas, JD, MPH, Director of the Law, Medicine, and Ethics Program of Boston University, commented on how effective a national DDR would be and what features it should have. Caplan pointed out that a national DDR would provide the advantages of speed, standardization, oversight, and accountability. He asked, “Why, then, are blood banks not asking Congress to pay to establish such a registry?” On the other hand, Caplan said that the United States does not appear to be ready for a national DDR, largely because there is not yet a consensus on quality control, criteria for entry into the DDR, or data collection issues. Annas stressed the need for national standards to be set prior to the establishment of a national DDR. “Absolute confidentiality” would have to be maintained with a national DDR. Caplan noted that all of these ethical issues would have to be discussed before decisions could be reached. What Legal Issues are Associated with the DDR? Karen Shoos Lipton, General Counsel to the ARC, National Headquarters, commented on three common areas of legal liability that stem from DDR usage: 1) failure to enter names in the DDR; 2) misapplication of the DDR (i.e., failure to properly screen against the DDR); and 3) inappropriate removal of names from the DDR. The decision to place someone’s name in the DDR results from information obtained from one or more various sources. Some donors’ names are entered into the DDR because of positive test results for infectious disease markers, some for health history responses, some for the confidential unit exclusion answer, and some for information obtained from third parties. While DDR entry decisions are relatively easy to make with information from the first three sources, Lipton stated that the decision is much more difficult to make with third-party information. For example, information acquired through a telephone call that challenges the donor’s eligibility can be neither ignored nor considered the basis for automatic entry into the DDR. Whatever decision is made, Lipton stressed that the blood center should document the reason(s) for that decision. Failure to check the DDR altogether or failure to document that it was checked constitutes a misapplication
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of the DDR. In some cases, problems arise because there was no means of positive donor identification; Lipton suggests that a confidential means of identification, similar to the access cards used for automatic bank tellers (or machines), should be explored as a possible means of standardizing donor identification. Lipton stated that removing names from the DDR involves some risk. For example, if a donor is implicated in a transfusion-associated disease and has been removed from the DDR, whether appropriately or not, legal liability may be difficult to defend. Lipton stressed that blood centers must use strict discipline when entering names into the DDR. The DDR should not be used as a means of dealing with a donor whose status can be resolved. Another topic discussed was the donor’s need and right to know that he or she has been listed in the DDR. Edward Wolf, Associate General Counsel to the ARC, stated that there are often legal and ethical issues involved with this practice. For example, it is the ethical duty of the blood center to share medically significant information with the donor, but there is a corresponding legal duty involving the prevention of donor illness or harm to third parties. Similarly, blood centers are ethically obligated not to expose donors unnecessarily to the risks and burdens of subsequent donations if the centers do not intend to use the blood that is donated. They also face potential legal exposure in the event of donor injury associated with these subsequent donations. Wolf asserted that failing to inform the donor that his or her donation will be discarded is a violation of donor rights. Wolf discussed the handling of third-party information that challenges a donor’s eligibility. There is a temptation to avoid informing the donor because of the awkwardness of the situation and because of the difficulty in assessing the credibility of the third party. If the information affects the donor’s eligibility, however, the blood center has a legal and ethical duty to notify the donor. From the growing need to share more donor information has emerged another issue: the management of
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the outflow of this information. Blood centers may be obligated to share donor information with other blood establishments when they have multiple facilities, with public health agencies when required by law, and with private third parties when committed by a prior formal agreement. Generally, the fact that information is being shared should be disclosed to the donor. In all cases, the information must be communicated in a confidential manner, and the establishment receiving the information must preserve confidentiality.
Conclusions The symposium was intended to provide a forum for the exchange of ideas, not to provide a consensus on any one topic. Several recurring issues were the need for 1) a standard means of donor identification, 2) linkages among DDRs in various blood banking organizations, 3) agreement regarding criteria for deferrals, and 4) confidentiality and attention to other donor rights issues. In addition, many speakers commented on the potential criteria for a national DDR. In closing, Jeffrey McCullough, MD, Senior Vice President for Biomedical Services at the ARC, expressed a need to continue these discussions and to bring these issues to the forefront, where they can get the attention they deserve.
References 1. 21 CFR 606.160(e). 2. Widmann FK, ed. Standards for blood banks and transfusion sewices. 13th ed. Arlington: American Association fo Blood Banks, 1991. 3. Dodd RY, Nath N. Increased risk for lethal forms of liver disease among HBsAg-positive blood donors in the United States. J Virol Methods 1987;17:81-94.
Brenda J. Grossman. MD, Medical Officer, Operations, American Red Cross National Headquarters. 1730 E Street, NW,Washington, DC 20006. [Reprint requests] Kathleen M. Springer, Senior Communication Associate, Blood Services, American Red Cross National Headquarters.
Blood donor deferral registries: highlights of a conference B.J. GROSSMAN AND K.M. SPRINGER GUESTEDITOR:T.F. ZUCK
How effective is the DDR in providing information about donors? What regulatory issues are related to the DDR? What ethical issues are related to the DDR? What legal issues are associated with the DDR? Highlights of the symposium are summarized below. The source materials for this summary are the authors’ (BJG and KMS) written notes and audiotapes of the conference. Each speaker reviewed that portion of the text in which his or her presentation was discussed.
THEDONOR DEFERRAL REGISTRY (DDR) is a file containing identifying information about blood donors who may have been disqualified from donating blood because of positive test results for a transmissible disease or an answer given in response to a health history question, or who have been implicated in a case of posttransfusion hepatitis or other infection. Some form of a DDR is required by the Code of Federal Regulations, which states, “A record shall be available from which unsuitable donors may be identified so that products [i.e., components] from such individuals will not be distributed.”’ The DDR is one of several measures used by blood banks to prevent the transfusion of unsafe blood. The DDR was originally conceived as a preventive means of improving the safety of the blood supply. During the early 1970s, blood banking organizations typically kept track of donors who had a history of hepatitis or who had positive test results for the hepatitis B surface antigen (HBsAg). Since the mid-l980s, when it became apparent that human immunodeficiency virus type 1 (HIV1) could be spread by a blood transfusion from an infected individual, the donor deferral categories have increased in quantity and complexity. With these increases, a variety of operational, legal, and ethical issues have surfaced. On July 17, 1991, the American Red Cross (ARC) convened a l-day symposium on blood donor deferral registries. The purpose of the meeting was to bring together for an open discussion representatives of those organizations that have a specific interest in DDR issues. Those attending the conference included physicians, ethicists, lawyers, and other persons interested in blood banking and transfusion medicine issues. The group considered the following questions: What role should the DDR play in protecting the safety of the blood supply? 0 How is the DDR being used in various blood banking organizations?
What Role Should the DDR Play in Protecting the Safety of the Blood Supply? Gerald V. Quinnan, MD, Acting Director of the Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), explained that the FDA places great importance on resolving DDR issues, even though current blood banking practices in the United States are probably the best in the world. According to Quinnan, 998 of every 1000 HIV-l-infected donors are detected by the current methods of donor health history screening, testing, confidential unit exclusion forms, and other deferral methods. The DDR plays a critical role in protecting the safety of the blood supply. Because blood banking organizations do not have a mechanism for sharing the names of deferred donors, it is possible for a donor to be deferred by one blood center and then to walk across the street and be accepted by another. Quinnan expressed a need for linkages between the different DDRs to make them ultimately effective. Robert Westphal, MD, Senior Principal Officer of the Vermont-New Hampshire Region of the ARC, discussed the changing indications for listing donors in the ARC DDR. The DDR initially protected the blood supply by deferring only those donors with positive test results for HBsAg; today’s DDR categories are more numerous and complex. Some donors who pose little harm to recipients are listed. For example, some organizations defer donors with elevated levels of alanine aminotransferase for an indefinite period of time. However, elevated levels of alanine aminotransferase may be caused by noninfectious factors, such as obesity, alcohol, exercise, and many drugs. Westphal stressed the importance of maintaining our perspective on what the DDR is supposed to accomplish. He recommended limiting the scope to recognized
Abbreviations: ABRA = American Blood Resources Associstion; ARC = Americsn Red Cross; DDR = donor deferral registry; FDA = Food and Drug Administration; HBsAg = hepstitis B surface sntigen; HIV-1 = human immunodeflciency virus type 1; NYBC = New York Blood Center. From the American Red Cross, National Headquarters, Washington, D.C. Rcccived for publication November 4, 1991; rcvision rcceived March 9, 1992, and acceptcd April 20, 1992.
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and measurable benefits to the recipients. In particular, he recommended using the DDR only to prevent the transmission of infectious diseases, not to list people who were taking medications or who had a history of cancer. In addition, he expressed a need to find a way to remove from the DDR those donors who are not potentially harmful to recipients of blood transfusions. Westphal believes the DDR needs a trap door to let the “innocent” people out. How is the DDR Being Used in Various Blood Banking Organizations? All blood banks use some form of a DDR as a means of tracking blood donors whose blood may not be safe for transfusion. Although blood banks may vary in the use and operation of their DDRs, there typically are several key features held in common. Five different DDRs were described at this meeting. The registries Ritchard Cable, MD, Medical Director of the Connecticut Region of the ARC, explained that the ARC has used a DDR since the early 1970s to identify donors who had a positive test result for HBsAg or had a history of hepatitis. Donors implicated in cases of posttransfusion hepatitis were added later. ARC blood centers currently screen donors against both a local DDR and an ARC national DDR. As of July 1991, the ARC national DDR contained approximately 250,000 names in 23 different deferral categories, including donors with positive test results for certain transfusion-transmissible diseases; donors with health histories or physical findings that suggest that the individual represents a high risk for transmitting certain transfusion-transmissible diseases; or donors under surveillance after being implicated in a single case of posttransfusion hepatitis. Local ARC DDRs track approximately 1 million additional names. These donors are listed for similar reasons as are the national DDR donors: however, the risks of transfusion-transmissible diseases are considered to be less. These 1.25 million names represent approximately 2 percent of the eligible donor population in the area covered by ARC blood centers. Kathleen Sazama, MD, JD, Associate Medical Director of the Sacramento (CA) Medical Foundation Center for Blood Research, reminded the conference attendees of the numerous categories into which donors are currently deferred according to the American Association Blood Banks standards.2 She then described the California state DDR that was created for hepatitis reporting by the legislature in 1975 and that was implemented the following year. Reporting in two categories was mandated: 1) donors who were seropositive (with or without confirmation), as reported by blood and plasma centers,
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and 2) patients with actual or suspected disease, as reported by hospitals, clinics, and physicians. When disease was suspected or determined to be due to transfusiontransmitted hepatitis, donors were also categorized separately as the sole donor or as one of several donors implicated in the transmission. Similar reporting of HIV1 was mandated legislatively in 1987, and the system retained the stratification of donors versus patients and eliminated the requirement for reporting the name of the test or the disease. In giving examples of the problems with the California DDR, Sazama noted that, as of February 1991, more than 169,000 names had been listed in four categories. Numerous duplicate, incomplete, inappropriate, and inaccurate entries make the system cumbersome and difficult to use. For example, the Sacramento Medical Foundation reported more than 350 donors but identified only 220 true “hits” between March 1, 1985, and February 28, 1991. The data are less useful than originally intended, in large part because of the differential reporting of disease by other health care entities and of seropositivity by blood and plasma centers. Dennis Harpool, Technical Consultant for Blood Systems, Inc., explained that Blood Systems’ blood centers are connected to a central computer system, and all centers currently check the donor’s name against the DDR after the donation is made. However, they are investigating the results of a pilot project in which the donor’s name is checked against the DDR before the donation is made. Blood Systems, Inc.’s DDR contains a list of all permanently and temporarily deferred donors. In addition to current listings, their computer maintains records of past DDR entries that may have been re-entered into the file of suitable donors. Another feature that Harpool described was the ability of the computer to prevent the release of a component still in inventory if a donor returns and is now unsuitable as a donor. In the future, their computer will also be able to keep track of the time limits for temporarily deferred donors. James Reilly, Vice President of Governmental Affairs of the American Blood Resources Association (ABRA), stated that the association’s members, which include plasma fractionators, have their own individual nationwide DDRs. ABRA is developing a single national DDR that would supplement and potentially replace these individual nationwide DDRs. ABRA’s DDR will be limited to donors with positive marker tests. Plasma collection facilities would be able to call a toll-free number from a touch-tone phone and to enter donor information, which is then screened against the DDR. Harold Kaplan, Senior Vice President for Medical Affairs of the New York Blood Center (NYBC), presented information about the NYBC’s DDR. Their DDR can be accessed from a personal or laptop computer at fixed sites, at mobiles, or in
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the laboratory. NYBC’s DDR is also provided to area hospitals. Donor identification Each speaker described donor identification problems. The absence of a single, recognized form of blood donor identification has posed significant problems within the DDR system. Most representatives reported that their institution’s DDR identifies donors by name, social security number, address, date of birth, and/or other types of information. However, because no positive donor identification is required at the time of donation, the information obtained is dependent on the donor’s provision of identical information at each donation. Thomas Zuck, MD, President of the Council of Community Blood Centers and Director of Hoxworth Blood Center, noted that misidentification is a serious problem and leads to duplicate records. If duplicate records are made and if, on the subsequent donation, the test results and health history are acceptable, a previously deferred donor could potentially be deemed suitable for donation. Zuck described a newly developed computer program that compares new entries to previous entries and calculates a score based on similarities in the entries. The purpose of this program is to capture “near matches” and to permit their resolution before the release of the unit of blood. Zuck explained that this system has been used successfully in capturing many duplicated records. Confidentiality Confidentiality is another important component in any DDR. Each DDR presented had some means of protecting the confidentiality of the information it contained. A very limited number of staff members are able to access the DDR, and unique passwords for individual staffers are used. In addition, the California DDR and the NYBC DDR do not list the reason for the entry into the DDR. The NYBC DDR also uses an encrypted data base. How Effective is the DDR in Providing Information About Donors? Operational information William Sherwood, MD, Senior Principal Officer of the Penn-Jersey Region of the ARC, stated that, although the DDR has been regarded as a measure by which to increase the safety of the blood supply, no definitive studies can be or have been performed to establish its efficacy. To do so would require transfusing units now regarded as unsafe, and that would not be acceptable. As an indirect method of measuring the value of the DDR, Sherwood described a study in progress in six ARC regions. The study compares the number of positive test results for infectious diseases in donors who
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have previously been notified that they are unsuitable donors with the number of positive test results in all volunteer donors and first-time volunteer donors during the same period of time. A remarkably large number of donors who have been notified that they are no longer eligible to donate return to do exactly that. Of more than 600,000 units studied, over 5000 (0.76%) were donated by previously deferred donors. Using data from this study, Sherwood showed that, although a significant number of unsuitable donors were intercepted through the DDR screening mechanisms, some categories of deferred donors had no increase in viral marker rates, which suggests that those donors are no less safe than the randomdonor population. In addition, a very small number of deferred donors from outside the region donated, which suggests a very limited value for the proposed national DDR. Research information Roger Dodd, PhD, Head of the Transmissible Diseases Laboratory of the Holland Laboratory of the ARC, pointed out that the DDR has distinct advantages and disadvantages as an aid to research. Some advantages are: that it is a single file of information; that it contains information about a large number of donors; and that it is automated and thus compatible with other electronic data systems. Some disadvantages to using the DDR as a research tool are: that its use may threaten the confidentiality of the information about the donor; that there is a lack of consistency in donor entries; that the true denominator is unknown; that there are no controls for comparison; and that it does not reflect the general population. Dodd pointed out that, despite these disadvantages, the DDR lends itself quite well to a variety of research, including operational evaluations, demographics in targeted populations, trends in deferral rates, and outcomes of diseases. For example, Dodd reviewed a previous study that showed that those donors with a positive test for HBsAg were more likely to die of liverrelated illnesses than were control donor^.^ Dodd suggested that the DDR could be used to help the blood industry understand the outcome in donors with positive test results for antibody to human T-lymphotropic virus type I or I1 or hepatitis C virus. Because outcome studies require some form of identification, which could interfere with the confidentiality of the file, Dodd proposed alternative methods to using the DDR to obtain this information. These included developing a prospective DDR of a target group of donors who have given consent or using unlinked demographics with a local data base. What Regulatory Issues Are Related to the DDR? According to Boyd Fogle, Director of the Division of Inspections and Surveillance of the FDA, one of the
TRANSFUSION 1992-Vol. 32, No. 9
DONOR DEFERRAL REGISTRIES
biggest problems FDA regulators identify in blood centers is the failure to control the proper disposition of unsuitable units of blood and blood components. The largest number of these unsuitable units is obtained from donors who should have been permanently or temporarily deferred because of health history or previous test results. Fogle noted that the number of blood component recalls has increased 150 to 200 percent since 1988, while only 33 percent of all error and accident reports submitted to the FDA have been related to the DDR. Recent FDA inspections have focused on how blood centers maintain control over their computer systems, how well they follow their own standard operating procedures, and how well they control the release of unsuitable units. Fogle said that the most common errors associated with the DDR during regulatory inspections are data entry errors, failure to follow standard operating procedures, inability to track multiple deferral codes, unauthorized changes in the DDR, lack of validation of computer systems, lack of manual backup for computer systems, duplicate record entry, and incomplete records. The FDA considers whether these errors occurred as an isolated event or as a recurring, systemic problem. The FDA evaluates the DDR in relation to testing, component labeling, and component release systems. In particular, the inspectors assess whether the error is one that represents a danger to health. Fogle emphasized the importance of planning and proper design. He noted that FDA is evaluating blood center systems to determine if they are operating under the proper controls. The FDA expects audit programs, with frequent reviews to ensure control over the system. The inspectors check the way that errors are investigated and corrected and evaluate the controls that have been established locally as well as in associated establishments. They ask questions. What are the prospects for the future? What preventive controls have been established to ensure that unsuitable blood components are not released? After considering the answers to these questions, the FDA will determine what regulatory action is appropriate. What Ethical Issues Are Related to the DDR? Arthur Caplan, PhD, Director of the Center for Biomedical Ethics at the University of Minnesota, provided a view of the ethical issues at stake in connection with the DDR. According to Caplan, the DDR promotes the goal of reducing the transmission of infectious diseases. However, rather than adding those deferred or “disqualified” donors to the list, it would be better actually to discourage these donors from giving blood again. Caplan pointed out problems in connection with receiving informed consent from donors. He noted that some of the notification letters and other materials in-
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forming the donor of the criteria for entry into the DDR are inadequate, because they are too technical to be understood easily by most blood donors. He stated that all notification letters should, at a minimum, have information about why the donor is being disqualified and what the options are for counseling. LouAnne Kennedy, PhD, Vice President of Academic Affairs at Kean College of New Jersey (Union, NJ), reiterated the importance of understandable notification materials. Many speakers, including Caplan and George Annas, JD, MPH, Director of the Law, Medicine, and Ethics Program of Boston University, commented on how effective a national DDR would be and what features it should have. Caplan pointed out that a national DDR would provide the advantages of speed, standardization, oversight, and accountability. He asked, “Why, then, are blood banks not asking Congress to pay to establish such a registry?” On the other hand, Caplan said that the United States does not appear to be ready for a national DDR, largely because there is not yet a consensus on quality control, criteria for entry into the DDR, or data collection issues. Annas stressed the need for national standards to be set prior to the establishment of a national DDR. “Absolute confidentiality” would have to be maintained with a national DDR. Caplan noted that all of these ethical issues would have to be discussed before decisions could be reached. What Legal Issues are Associated with the DDR? Karen Shoos Lipton, General Counsel to the ARC, National Headquarters, commented on three common areas of legal liability that stem from DDR usage: 1) failure to enter names in the DDR; 2) misapplication of the DDR (i.e., failure to properly screen against the DDR); and 3) inappropriate removal of names from the DDR. The decision to place someone’s name in the DDR results from information obtained from one or more various sources. Some donors’ names are entered into the DDR because of positive test results for infectious disease markers, some for health history responses, some for the confidential unit exclusion answer, and some for information obtained from third parties. While DDR entry decisions are relatively easy to make with information from the first three sources, Lipton stated that the decision is much more difficult to make with third-party information. For example, information acquired through a telephone call that challenges the donor’s eligibility can be neither ignored nor considered the basis for automatic entry into the DDR. Whatever decision is made, Lipton stressed that the blood center should document the reason(s) for that decision. Failure to check the DDR altogether or failure to document that it was checked constitutes a misapplication
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TRANSFUSION
GROSSMAN AND SPRINGER
of the DDR. In some cases, problems arise because there was no means of positive donor identification; Lipton suggests that a confidential means of identification, similar to the access cards used for automatic bank tellers (or machines), should be explored as a possible means of standardizing donor identification. Lipton stated that removing names from the DDR involves some risk. For example, if a donor is implicated in a transfusion-associated disease and has been removed from the DDR, whether appropriately or not, legal liability may be difficult to defend. Lipton stressed that blood centers must use strict discipline when entering names into the DDR. The DDR should not be used as a means of dealing with a donor whose status can be resolved. Another topic discussed was the donor’s need and right to know that he or she has been listed in the DDR. Edward Wolf, Associate General Counsel to the ARC, stated that there are often legal and ethical issues involved with this practice. For example, it is the ethical duty of the blood center to share medically significant information with the donor, but there is a corresponding legal duty involving the prevention of donor illness or harm to third parties. Similarly, blood centers are ethically obligated not to expose donors unnecessarily to the risks and burdens of subsequent donations if the centers do not intend to use the blood that is donated. They also face potential legal exposure in the event of donor injury associated with these subsequent donations. Wolf asserted that failing to inform the donor that his or her donation will be discarded is a violation of donor rights. Wolf discussed the handling of third-party information that challenges a donor’s eligibility. There is a temptation to avoid informing the donor because of the awkwardness of the situation and because of the difficulty in assessing the credibility of the third party. If the information affects the donor’s eligibility, however, the blood center has a legal and ethical duty to notify the donor. From the growing need to share more donor information has emerged another issue: the management of
Vol. 32. No. 9-1992
the outflow of this information. Blood centers may be obligated to share donor information with other blood establishments when they have multiple facilities, with public health agencies when required by law, and with private third parties when committed by a prior formal agreement. Generally, the fact that information is being shared should be disclosed to the donor. In all cases, the information must be communicated in a confidential manner, and the establishment receiving the information must preserve confidentiality.
Conclusions The symposium was intended to provide a forum for the exchange of ideas, not to provide a consensus on any one topic. Several recurring issues were the need for 1) a standard means of donor identification, 2) linkages among DDRs in various blood banking organizations, 3) agreement regarding criteria for deferrals, and 4) confidentiality and attention to other donor rights issues. In addition, many speakers commented on the potential criteria for a national DDR. In closing, Jeffrey McCullough, MD, Senior Vice President for Biomedical Services at the ARC, expressed a need to continue these discussions and to bring these issues to the forefront, where they can get the attention they deserve.
References 1. 21 CFR 606.160(e). 2. Widmann FK, ed. Standards for blood banks and transfusion sewices. 13th ed. Arlington: American Association fo Blood Banks, 1991. 3. Dodd RY, Nath N. Increased risk for lethal forms of liver disease among HBsAg-positive blood donors in the United States. J Virol Methods 1987;17:81-94.
Brenda J. Grossman. MD, Medical Officer, Operations, American Red Cross National Headquarters. 1730 E Street, NW,Washington, DC 20006. [Reprint requests] Kathleen M. Springer, Senior Communication Associate, Blood Services, American Red Cross National Headquarters.
