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Published online by Cambridge University Press: 29 April 2021
A federal requirement that donor blood be labelled as either “paid” or “volunteer” took effect on May 15, 1978. A major rationale for requiring such labelling is that physicians, now that they can distinguish between categories of blood, will fear liability for post-transfusion hepatitis resulting from the use of paid blood. Thus, supporters of the labelling requirement hope that it will deter the use of high-risk commercial blood. Some paid blood, however, is not commercial blood and in fact may be safer than volunteer blood. The labelling strategy for hepatitis control, therefore, has negative as well as positive attributes. This Article considers the efficacy of blood labelling as a hepatitis control measure and proposes an alternative strategy—the periodic publicizing of hepatitis rates of facilities that perform transfusions—that, if practiced responsibly, could significantly decrease hepatitis transmission rates.
1 In this Article, “paid” blood means blood for which the donor receives monetary payment, and “volunteer” blood means blood for which the donor receives no monetary payment.
As explained in Part III-B below, researchers in the post-transfusion hepatitis field rarely distinguish between what should be considered two separate subcategories of “paid” blood: (1) “paid-commercial” blood (for which the donor is paid by a for-profit blood collection agency); and (2) “paid-noncommercial” blood (for which the donor is paid by a nonprofit blood collection agency). Furthermore, some researchers who use the word “commercial” may actually mean “paid,” including both commercial and noncommercial. It is hoped that in the text of this Article, decisions to use “commercial” or “paid” in referring to the results of particular research studies is appropriate in each case, but because of the ambiguities described above, some inconsistencies may exist.
It should also be noted that many donors who would be considered “volunteers” under the definition used in this Article do receive non-cash inducements for giving blood, such as vacation time from their employer or blood for themselves should they ever need it. See Holley, & Linkenhoker, Do Volunteer Donors Decrease Posttransfusion Hepatitis? 234 J. Am. Med. Ass'n 1051, 1052 (1975)CrossRefGoogle Scholar.
2 See, e.g., Allen, Commercially Obtained Blood and Serum Hepatitis, 131 Surgery, Gynecology and Obstetrics 277 (1970)Google Scholar.
3 See Titmuss, R. M., The Gift Relationship: From Human Blood to Social Policy (1971)Google Scholar.
4 See Blumberg, Australia Antigen and the Biology of Hepatitis B, 197 Science 17 (1977)CrossRefGoogle Scholar.
5 See Surgenor, Progress Toward a National Blood System: The American Blood Commission, 294 New England J. Med. 1367 (1976)CrossRefGoogle Scholar.
6 21 C.F.R. § 606.120(b)(2) (1978).
7 An antigen is a substance, usually protein or carbohydrate, that when introduced into the body stimulates the production of an antibody. Webster's New Collegiate Dictionary 50(1971)Google Scholar.
8 Virus type hepatitis A has a short incubation period (15-45 days), seasonal variation, and an association with shellfish, epidemics, and natural disasters. Type B has a longer incubation period (60-180 days). Additional viruses not yet identified, but probably related to types A and B, have been referred to as “non-A, non-B” hepatitis, and many exhibit an intermediate length incubation period. Types B and “non-A, non-B” have been regarded as the causative agents where a needle;—either contaminated itself or transferring contaminated fluid—is identifiable as the likely mode of transmission, as is the case for post-transfusion hepatitis.
9 Bryan, & Gregg, Viral Hepatitis in the United States, 1970-1973: An Analysis of Morbidity Trends and the Impact of HBsAg Testing on Surveillance and Epidemiology, 270 Am. J. Medical Sciences 271 (1975)CrossRefGoogle Scholar.
10 Office of the Assistant Secretary for Health, HEW, Post-Transfusion Hepatitis: Cases, Deaths, and Costs (1973).
11 See generally Koff, et al., Underreporting of Viral Hepatitis, 64 Gastroenterology 1194 (1973)CrossRefGoogle Scholar (correspondence).
12 26 Morbidity and Mortality Weekly Report 177 (1977)Google Scholar.
13 Center for Disease Control, HEW, Rep. No. 36, Hepatitis Surveillance (1973).
14 Another approach to estimating hepatitis case incidence rates is to extrapolate reports of experience in single institutions or groups of institutions that participate in multi-centered cooperative studies. Variability must be recognized, however, in the intensity of the follow-up of transfusion patients that leads to case reports. Many institutions reporting their transfusion hepatitis occurrence rates do little more than wait for case reports to arrive through the mail, while others actively solicit patient status information at regular intervals. Under circumstances that may be typical, a 10-year study by the New Jersey State Department of Health discovered unreported hepatitis cases through record-room chart review several years later. On the average, about 30 percent of cases that eventually were identified had been missed originally. See M. Goldfield, An Epidemiologic Study of Transfusion Associated Hepatitis, Progress Report, New Jersey State Department of Health, 1977.
15 Qualitatively the risks of whole blood transfusion seem to apply as well to packed red cells and clotting factor preparations. On the other hand, plasma expanders used to treat accidental loss of blood volume undergo pasteurization as part of the manufacturing process and are safe from transmitting clinical disease irrespective of donor source. See Barker, & Hoofnagle, Hepatitis B and Albumin Products, in HEW, Pub. No. (NIH) 76-925, Proceedings of the Workshop on Albumin 305 (1976)Google Scholar.
16 Relative hepatitis risk of blood components and products is currently the subject of investigation by one of the authors (S.F.) in collaboration with others.
17 Prince, et al., Posttransfusion Viral Hepatitis caused by an Agent or Agents Other Than Hepatitis B Virus or Hepatitis A Virus. Impact on Efficiency of Present Screening Methods, in Transmissible Disease and Blood Transfusion 129, 131 (Greenwalt, T.J. & Jamieson, G.A., eds. 1975)Google Scholar.
18 The tests were less effective in identifying hepatitis A; this type, however, can be more easily diagnosed clinically than can hepatitis B.
19 Allen, Altering the Natural History of Posttransfusion Hepatitis, in The Epidemiology of Posttransfusion Hepatitis: Basic Blood and Plasma Tabulations 43-58 (1972)Google Scholar. See also Allen, supra note 2.
20 M. Goldfield, supra note 11, Tables 23 & 24.
21 U.S. General Accounting Office, Pub. No. MWD-75-82, Hepatitis from Blood Transfusions: Evaluation of Methods to Reduce the Problem (Feb. 1976).
22 M. Goldfield, An Epidemiologic Study of Transfusion Associated Hepatitis, Progress Report, New Jersey State Department of Health, 1974.
23 See Alter, Holland, & Purcell, The Emerging Pattern of Post-Transfusion Hepatitis, 270 Am. J. Medical Sciences 329 (1975)CrossRefGoogle Scholar.
24 Szmuness, et al., Hepatitis B Surface Antigen in Blood Donors: Further Observations, in 131 J. Infectious Diseases 111 (1975)CrossRefGoogle Scholar.
25 National Transfusion Hepatitis Study, Risk of Posttransfusion Hepatitis in the United States: A Prospective Cooperative Study, 220 J. Am. Med. Ass'n 692 (1972)CrossRefGoogle Scholar.
26 Los Angeles, Chicago, Baltimore, and Bethesda, Maryland. U.S. General Accounting Office, supra note 21, at 15.
27 Id.
28 See, e.g., Alsever, & Von Schoonhoven, Posttransfusion Viral Hepatitis (PTVH): Myths and Facts, 31 Arizona Medicine 263 (1974)Google Scholar; Holley, & Linkenhoker, Do Volunteer Donors Decrease Post-transfusion Hepatitis? 234 J. Am. Med. Ass'n 1051 (1975)CrossRefGoogle Scholar; Division of Medical Care, Massachusetts Dep't of Public Health, Dependence of Massachusetts Blood Banks on Paid Donors—1971 (1972).
29 21 C.F.R. § 606.120(b)(2) (1978).
30 Another suggested approach is to mandate a standard for the maximum acceptable rate of hepatitis transmission. Blood from collection agencies that exceeded the standard could not be used in transfusions. The problem with this approach is that no rate could be established except through use. A blood supply disqualified because of poor performance could only requalify by being tested on a recipient population. Alternatively, collectors who provided a supply that failed to meet the standard might be barred permanently from offering blood. Such an approach would be likely soon to lead to severe shortages in blood supplies.
One commentator has proposed the imposition of tort liability on blood suppliers for injuries resulting from post-transfusion hepatitis attributable to blood they have collected negligently. Note, Pricing Bad Blood: Reassessing Liability for Post-transfusion Hepatitis, 15 Harv. J. Leg. 558 (1978)Google Scholar. The present authors, as nonlawyers, feel that a discussion of this argument is outside their expertise.
