TRANSFUSION Volume 32
October 1992
Number 8
Editorials
Is the deferred-donor notification process effective? opinion2that there is an inescapable responsibility to do so. In fact, current standards3 of the American Association of Blood Banks require that a mechanism be present to notify donors of “any clinically significant abnormalities detected during the predonation evaluation or during laboratory testing.” The definition of “clinically significant” is left to local interpretation. Donor notification is not referenced in 21 CFR part 600 but has essentially been mandated through the use of official Public Health Service guidelines and recommendations. General public health concerns would also suggest that notification be performed when secondary spread of infection could be prevented by appropriate action. Finally, there is perhaps also a legal obligation to inform the donor of test results that may have an impact on his or her health or the health of those who may be secondarily affected. An obligation to notify appears certain; however, the most effective method of notification has not been determined. One measure of effectiveness is the achievement of a desired outcome, perhaps whether the donor gained certain knowledge or took specific action as a result of notification. Moyer et al. report their assessment of effectiveness of the process of notifying donors found to be positive for hepatitis B surface antigen. The results were enlightening and yet sobering, in that nearly one-quarter of the donors did not understand from their notification letters that they had an abnormal blood test and were infected with hepatitis B virus. Given these findings, it is not surprising that a similar percentage did not seek medical care and therefore did not have an opportunity to learn the implications of the reactive test result for themselves or their close contacts. It is disconcerting that most donors who sought medical care did not recall receiving appropriate recommendations concerning protection for household and sexual contacts. Furthermore, even when correct advice was provided, it was heeded by only three-quarters of the donors. These findings suggest that improvement in the process of donor notification is possible and desirable.
Driven by the desire to reduce the risk of acquiring transfusion-associated infection to the lowest level [as low as] possible, numerous changes in the process of donor selection have occurred since 1983. While this process has resulted in a much safer blood supply, it has changed forever the relationship between the altruistic blood donor and the blood collection facility. Donor health screening has become almost an inquisition, and donors are unintentionally considered “guilty” of being unsuitable for acceptance for donation until they are proven “innocent” by the trials of the health history, deferreddonor registry review, and, ultimately, the increasingly extensive testing of their blood. One new or improved version of a laboratory test is being added each year to the battery of required donor screening tests. To respond to the public’s desire for a safe and, preferably, although unrealistically, risk-free blood supply, tests are often mandated by regulatory agencies before the implications of reactive test results among a low-risk population, such as blood donors, have been evaluated. Not uncommonly at the time of introduction, the tests have high rates of nonspecificity, and confirmatory tests are unavailable. Blood centers are left to deal with these testing inadequacies and the confusion, frustration, and resentment they cause for donors. Introduction of each new or improved test has resulted in an increase in the number of donors who must be temporarily, indefinitely, or permanently deferred from donating blood. What is our obligation to these donors? What should they be told, and how should the message be given? What do they do with the information that is given to them? Should the blood center assume the role of donor advocate to ensure that donors receive appropriate guidance and follow-up testing by their physicians? These and other questions are raised by the article of Moyer et al.’ in this issue of TRANSFUSION. Unfortunately, few if any firm answers to such questions exist. Do blood centers have an obligation to notify donors of reasons for deferral? Most would agree with Sayers’
696
TRANS N SI0N
1992-Vol. 32. No. 8
EDITORIAL
What Information Should Be Provided? To be most beneficial to donors and their physicians, notification cannot simply consist of a report of abnormal test results. The possible significance of such tests for the donor and his or her household or sexual contacts should be explained and suggestions for action should be given. In addition, the donor should be informed of any action the blood center is required to take related to reporting of the donor’s test results to a third party such as local or state health departments. The donor should also be informed of the implications of such reporting. Because many donors will seek guidance from their physicians, results of significant related screening tests should also be provided. For example, alanine aminotransferase values from current and/or previous donations would aid the physician in interpretation of a reactive hepatitis C antibody test. To further assist the physician, it may be preferable for the blood center also to perform supplemental testing, that is, additional unrequired and usually unlicensed tests, prior to notification. These tests, such as recombinant antigen panels for evaluation of reactive hepatitis C antibody tests, may not otherwise be available to the donor otherwise because his or her physician is not familiar with them or does not have access to them in the community. There are, however, negatives associated with the use of such tests. Their expense, which is not trivial, is passed on to transfusion recipients in the form of higher component processing fees. These tests are often performed in research settings, and performance of the test may not be consistent; therefore, the interpretation of test results may be incorrect or misleading. In addition, the United States Food and Drug Administration has in the past expressed concern over use of these tests as indicators of need for donor notification or referral to a physician for further evaluation. How Should Donors Be Notified? Most blood centers notify donors of deferral by letter. To be effective, materials prepared for donor notification should be understandable by donors at the lowest reading level of the expected audience. The difficulty of this task is illustrated by the letter appended to Moyer’s article. Based on the Gunning Fog Reading Index,4 the letter is written at a fourth-year college level. Even for an individual with a high level of education, terms such as “hepatitis marker,” “antigen,” “immune system,” “antibody,” and “postinfectious immunity” are unlikely to be understood fully without some medical or technical training. As difficult as it may be to make information related to positive tests for hepatitis B surface antigen understandable to the general donor population, it is relatively simple in comparison to explaining the nuances of the
697
donor screening tests introduced since 1985. These include false positivity of results, indeterminant confirmation results, the use of tests as surrogate markers, and the need for and meaning of supplemental testing using unlicensed research tests. In our attempt to explain concepts such as these in notification letters, we often bewilder donors. To enhance donor understanding and compliance with required or desired actions, blood centers have hired counselors specifically to help donors understand the intended message of notification. The impetus for this action was the need to counsel human immunodeficiency virus antibody-reactive donor^;^ however, such counselors are now used to educate donors deferred for any reason. Although a very important resource for deferred donors, they add substantially to the expense associated with notification. How Should Health Care Providers Be Educated? Education of the donor’s health care provider is a critical, but often weak, link in the notification process. To be most helpful to the donor and their contacts, physicians should be provided with adequate information by the blood center. This information should include the donor’s test results, both for the index test and for all testing that may bear on its interpretation. It is also useful to provide the physician with background information related to the testing and, if available, specific recommendations from the Public Health Service or other agencies for the management of the donor. If donor centers do not take the initiative to provide the physician with adequate information, both the donor and the blood center may suffer. This became evident following the introduction of testing for antibody to hepatitis B core antigen (anti-HBc). Some anti-HBc-reactive donors who sought assistance from health care providers, and underwent additional laboratory studies, incurred charges totalling hundreds of dollars. These studies often consisted of chemistry profiles and a panel of tests to detect acute hepatitis. As might be expected, results were often reported as normal. Frequently, physicians could not reconcile what they interpreted as disparate results, and the donor was informed that the blood center results were obviously in error. Donors reacted to this information with anger and demanded that the blood center change their records to correct the “mistake” and provide reimbursement for the cost of the physician visit and testing. Because the physician was not better informed, the blood center lost credibility with both the physician and the donor. Indirectly, the safety of the blood supply was brought into question because of the perception that donor screening tests were often incorrect. A need for greater physician education is supported by the finding of Moyer et al. that less than one-half of
698
TRANSFUSION
EDITORIAL
the donors surveyed received appropriate recommendations for the prevention of hepatitis B virus transmission. Given the relative lack of experience of most health care providers with newly identified viruses such as human T-lymphotropic virus type I (HTLV-I) or hepatitis C virus, it would be expected that they would be even less accurate in counseling donors with laboratory evidence of these infections. Health care providers should not be assumed to be experts in these areas; in fact, we should assume they are uninformed and provide them with information to help correct deficiencies in their knowledge so that the donor is better served. Who Bears the Cost of Notification?
As more screening tests, especially those lacking desired specificity, have been added over the last several years, the notification workload has increased, and staff have been added to handle the process. The expenses incurred are necessary to ensure that donors receive accurate and timeIy notification. These activities do not directly facilitate the delivery of adequate quantities of blood to patients in need, nor do they increase the safety of the blood supply. Yet, the cost of such activities is passed on in the fees for processing blood components and is borne by transfusion recipients who only indirectly benefit. In our experience, the cost of operation of our blood center is increased by at least $1 per unit collected to support the notification process. This does not include the cost of supplemental testing which, for hepatitis C virus alone, as an example, is $38 per test. Notification expenses in other centers may be less, but in many they are probably much greater. If $1 per collected unit is arbitrarily taken to represent the average added cost in the United States, a total of $12 million may be added to health care expenditures as a result of these efforts.
Vol. 32. No. 8-1992
Although economies of operation will allow reduction in costs, the overall dollars required can be expected to continue to total millions each year. A major reduction in these costs could occur with improvement in specificity of tests to reduce false-positive results. Additional cost reductions would follow the elimination of requirements for screening tests that are no longer beneficial. Are our notification processes effective, and are they worth the considerable effort and expense? The answers to these questions are important to know, and further studies like that of Moyer et al. will help provide some of the answers. Similar studies to evaluate the comprehension of donors deferred because of reactive surrogate tests or tests for newly described agents, such as hepatitis C virus and HTLV-I, would be helpful. The primary physician’s role in this process should also be evaluated further. Additional research in this important area should be pursued. EDWARD P. Scon, MD Medical DirectorlCEO EVA D. QUINLEY, MS, MT(ASCP)SBB Director, Education and Communications LijebloodlMid-South Regional Blood Center 1040 Madison Avenue Memphis, TN 38104-2198 References 1. Moyer LA, Shapiro CN, Shulman G, Brugliera PD, Alter MJ. A survey of hepatitis B surface antigen-positiveblood donors: degree of understanding and action taken after notification. Transfusion 1992:7026. 2. Sayers MH. Duties to donors. Transfusion 1992:32:465-6. 3 Widmann FK, ed. Standards for blood banks and transfusion scrvices. 14th ed. Arlington: American Association of Blood Banks, 1991. 4. Laubach R., Koschnik K. Using readability formulas for easy adult materials. Syracuse: New Readers Press, 1977:12. 5. Cleary PD, Rogers TF, Singer E, et at. Health education about AIDS among seropositive blood donors. Health Educ Q 1986;13:317-29.
October 1992
Number 8
Editorials
Is the deferred-donor notification process effective? opinion2that there is an inescapable responsibility to do so. In fact, current standards3 of the American Association of Blood Banks require that a mechanism be present to notify donors of “any clinically significant abnormalities detected during the predonation evaluation or during laboratory testing.” The definition of “clinically significant” is left to local interpretation. Donor notification is not referenced in 21 CFR part 600 but has essentially been mandated through the use of official Public Health Service guidelines and recommendations. General public health concerns would also suggest that notification be performed when secondary spread of infection could be prevented by appropriate action. Finally, there is perhaps also a legal obligation to inform the donor of test results that may have an impact on his or her health or the health of those who may be secondarily affected. An obligation to notify appears certain; however, the most effective method of notification has not been determined. One measure of effectiveness is the achievement of a desired outcome, perhaps whether the donor gained certain knowledge or took specific action as a result of notification. Moyer et al. report their assessment of effectiveness of the process of notifying donors found to be positive for hepatitis B surface antigen. The results were enlightening and yet sobering, in that nearly one-quarter of the donors did not understand from their notification letters that they had an abnormal blood test and were infected with hepatitis B virus. Given these findings, it is not surprising that a similar percentage did not seek medical care and therefore did not have an opportunity to learn the implications of the reactive test result for themselves or their close contacts. It is disconcerting that most donors who sought medical care did not recall receiving appropriate recommendations concerning protection for household and sexual contacts. Furthermore, even when correct advice was provided, it was heeded by only three-quarters of the donors. These findings suggest that improvement in the process of donor notification is possible and desirable.
Driven by the desire to reduce the risk of acquiring transfusion-associated infection to the lowest level [as low as] possible, numerous changes in the process of donor selection have occurred since 1983. While this process has resulted in a much safer blood supply, it has changed forever the relationship between the altruistic blood donor and the blood collection facility. Donor health screening has become almost an inquisition, and donors are unintentionally considered “guilty” of being unsuitable for acceptance for donation until they are proven “innocent” by the trials of the health history, deferreddonor registry review, and, ultimately, the increasingly extensive testing of their blood. One new or improved version of a laboratory test is being added each year to the battery of required donor screening tests. To respond to the public’s desire for a safe and, preferably, although unrealistically, risk-free blood supply, tests are often mandated by regulatory agencies before the implications of reactive test results among a low-risk population, such as blood donors, have been evaluated. Not uncommonly at the time of introduction, the tests have high rates of nonspecificity, and confirmatory tests are unavailable. Blood centers are left to deal with these testing inadequacies and the confusion, frustration, and resentment they cause for donors. Introduction of each new or improved test has resulted in an increase in the number of donors who must be temporarily, indefinitely, or permanently deferred from donating blood. What is our obligation to these donors? What should they be told, and how should the message be given? What do they do with the information that is given to them? Should the blood center assume the role of donor advocate to ensure that donors receive appropriate guidance and follow-up testing by their physicians? These and other questions are raised by the article of Moyer et al.’ in this issue of TRANSFUSION. Unfortunately, few if any firm answers to such questions exist. Do blood centers have an obligation to notify donors of reasons for deferral? Most would agree with Sayers’
696
TRANS N SI0N
1992-Vol. 32. No. 8
EDITORIAL
What Information Should Be Provided? To be most beneficial to donors and their physicians, notification cannot simply consist of a report of abnormal test results. The possible significance of such tests for the donor and his or her household or sexual contacts should be explained and suggestions for action should be given. In addition, the donor should be informed of any action the blood center is required to take related to reporting of the donor’s test results to a third party such as local or state health departments. The donor should also be informed of the implications of such reporting. Because many donors will seek guidance from their physicians, results of significant related screening tests should also be provided. For example, alanine aminotransferase values from current and/or previous donations would aid the physician in interpretation of a reactive hepatitis C antibody test. To further assist the physician, it may be preferable for the blood center also to perform supplemental testing, that is, additional unrequired and usually unlicensed tests, prior to notification. These tests, such as recombinant antigen panels for evaluation of reactive hepatitis C antibody tests, may not otherwise be available to the donor otherwise because his or her physician is not familiar with them or does not have access to them in the community. There are, however, negatives associated with the use of such tests. Their expense, which is not trivial, is passed on to transfusion recipients in the form of higher component processing fees. These tests are often performed in research settings, and performance of the test may not be consistent; therefore, the interpretation of test results may be incorrect or misleading. In addition, the United States Food and Drug Administration has in the past expressed concern over use of these tests as indicators of need for donor notification or referral to a physician for further evaluation. How Should Donors Be Notified? Most blood centers notify donors of deferral by letter. To be effective, materials prepared for donor notification should be understandable by donors at the lowest reading level of the expected audience. The difficulty of this task is illustrated by the letter appended to Moyer’s article. Based on the Gunning Fog Reading Index,4 the letter is written at a fourth-year college level. Even for an individual with a high level of education, terms such as “hepatitis marker,” “antigen,” “immune system,” “antibody,” and “postinfectious immunity” are unlikely to be understood fully without some medical or technical training. As difficult as it may be to make information related to positive tests for hepatitis B surface antigen understandable to the general donor population, it is relatively simple in comparison to explaining the nuances of the
697
donor screening tests introduced since 1985. These include false positivity of results, indeterminant confirmation results, the use of tests as surrogate markers, and the need for and meaning of supplemental testing using unlicensed research tests. In our attempt to explain concepts such as these in notification letters, we often bewilder donors. To enhance donor understanding and compliance with required or desired actions, blood centers have hired counselors specifically to help donors understand the intended message of notification. The impetus for this action was the need to counsel human immunodeficiency virus antibody-reactive donor^;^ however, such counselors are now used to educate donors deferred for any reason. Although a very important resource for deferred donors, they add substantially to the expense associated with notification. How Should Health Care Providers Be Educated? Education of the donor’s health care provider is a critical, but often weak, link in the notification process. To be most helpful to the donor and their contacts, physicians should be provided with adequate information by the blood center. This information should include the donor’s test results, both for the index test and for all testing that may bear on its interpretation. It is also useful to provide the physician with background information related to the testing and, if available, specific recommendations from the Public Health Service or other agencies for the management of the donor. If donor centers do not take the initiative to provide the physician with adequate information, both the donor and the blood center may suffer. This became evident following the introduction of testing for antibody to hepatitis B core antigen (anti-HBc). Some anti-HBc-reactive donors who sought assistance from health care providers, and underwent additional laboratory studies, incurred charges totalling hundreds of dollars. These studies often consisted of chemistry profiles and a panel of tests to detect acute hepatitis. As might be expected, results were often reported as normal. Frequently, physicians could not reconcile what they interpreted as disparate results, and the donor was informed that the blood center results were obviously in error. Donors reacted to this information with anger and demanded that the blood center change their records to correct the “mistake” and provide reimbursement for the cost of the physician visit and testing. Because the physician was not better informed, the blood center lost credibility with both the physician and the donor. Indirectly, the safety of the blood supply was brought into question because of the perception that donor screening tests were often incorrect. A need for greater physician education is supported by the finding of Moyer et al. that less than one-half of
698
TRANSFUSION
EDITORIAL
the donors surveyed received appropriate recommendations for the prevention of hepatitis B virus transmission. Given the relative lack of experience of most health care providers with newly identified viruses such as human T-lymphotropic virus type I (HTLV-I) or hepatitis C virus, it would be expected that they would be even less accurate in counseling donors with laboratory evidence of these infections. Health care providers should not be assumed to be experts in these areas; in fact, we should assume they are uninformed and provide them with information to help correct deficiencies in their knowledge so that the donor is better served. Who Bears the Cost of Notification?
As more screening tests, especially those lacking desired specificity, have been added over the last several years, the notification workload has increased, and staff have been added to handle the process. The expenses incurred are necessary to ensure that donors receive accurate and timeIy notification. These activities do not directly facilitate the delivery of adequate quantities of blood to patients in need, nor do they increase the safety of the blood supply. Yet, the cost of such activities is passed on in the fees for processing blood components and is borne by transfusion recipients who only indirectly benefit. In our experience, the cost of operation of our blood center is increased by at least $1 per unit collected to support the notification process. This does not include the cost of supplemental testing which, for hepatitis C virus alone, as an example, is $38 per test. Notification expenses in other centers may be less, but in many they are probably much greater. If $1 per collected unit is arbitrarily taken to represent the average added cost in the United States, a total of $12 million may be added to health care expenditures as a result of these efforts.
Vol. 32. No. 8-1992
Although economies of operation will allow reduction in costs, the overall dollars required can be expected to continue to total millions each year. A major reduction in these costs could occur with improvement in specificity of tests to reduce false-positive results. Additional cost reductions would follow the elimination of requirements for screening tests that are no longer beneficial. Are our notification processes effective, and are they worth the considerable effort and expense? The answers to these questions are important to know, and further studies like that of Moyer et al. will help provide some of the answers. Similar studies to evaluate the comprehension of donors deferred because of reactive surrogate tests or tests for newly described agents, such as hepatitis C virus and HTLV-I, would be helpful. The primary physician’s role in this process should also be evaluated further. Additional research in this important area should be pursued. EDWARD P. Scon, MD Medical DirectorlCEO EVA D. QUINLEY, MS, MT(ASCP)SBB Director, Education and Communications LijebloodlMid-South Regional Blood Center 1040 Madison Avenue Memphis, TN 38104-2198 References 1. Moyer LA, Shapiro CN, Shulman G, Brugliera PD, Alter MJ. A survey of hepatitis B surface antigen-positiveblood donors: degree of understanding and action taken after notification. Transfusion 1992:7026. 2. Sayers MH. Duties to donors. Transfusion 1992:32:465-6. 3 Widmann FK, ed. Standards for blood banks and transfusion scrvices. 14th ed. Arlington: American Association of Blood Banks, 1991. 4. Laubach R., Koschnik K. Using readability formulas for easy adult materials. Syracuse: New Readers Press, 1977:12. 5. Cleary PD, Rogers TF, Singer E, et at. Health education about AIDS among seropositive blood donors. Health Educ Q 1986;13:317-29.
