oversight

Blood Supply: Availability of Blood to Meet the Nation's Requirements

Published by the Government Accountability Office on 1999-09-20.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

c        Accountabllily   * Integrity   l   Reliability

United States General Accounting                          Office                             Health, Education, and
Washington, DC 20548                                                                       Human Services Division




            B-283557

            September 20,1999


            The Honorable Tom Bliley
            Chairman, Committee on Commerce
            House of Representatives

            Subject: Blood Sunulv: Availabilitv of Blood to Meet the Nation’s Reauirements

            Dear Mr. Chairman

            A recent report by the National Blood Data Resource Center (NBDRC), a group representing
            blood banks, projected that the demand for blood will outstrip the available supply by next
            year. At the same time, the Department of Health and Human Services (HHS), which
            oversees the nation’s blood supply, has initiated a major policy change-and is considering
            another-that could further affect the blood supply. Specifically, the Department’s Food and
            Drug Administration (FDA) has recommended prohibiting blood donations from individuals
            who spent 6 months or more in the United Kingdom between 1980 and the end of 1996
            because of concerns over the possible transmissibility of new variant Creutzfeldt-Jakob
            disease (nvCJD), the human form of “mad cow” disease. HHS has also proposed removing
            barriers to donations by individuals with hemochromatosis-an iron-overload disease that
            may be treated by drawing blood-to make up some of the loss in blood donations.

            In light of these developments, you asked us to provide information on (1) recent trends in
            blood donation and the demand for blood transfusions, (2) the expected effect of a ban on
            blood from donors who have traveled to the United Kingdom, and (3) the potential effect of
            policy changes to allow units of blood collected from individuals with hemochromatosis to
            be distributed.

            In summary, we found that, while there is cause for concern about shortages of certain blood
            types or in certain regions, the blood supply as a whole is not in crisis. We believe that the
            NBDRC study overstates the decline in the blood supply. Most of the decline found by
            NBDRC was in donations targeted for specific individuals, not in the commumty supply of
            blood available to anyone in need. Further, the projection relies on data from only 2 years,
            the most recent of which is now 2 years old. The U.K. donor exclusion policy has been
            estimated to reduce the blood supply by approximately 2.2 percent. Blood banks fear that
            the actual loss due to this exclusion will be greater, but it is not possible to assess the
            accuracy of these estimates. While the estimates of the potential increase in the blood supply
            from donations by individuals with hemochromatosis vary widely, most of these increases
            could not occur until current regulations are changed. Therefore, such donations will not
            affect the available blood supply for some time.

            1
                                                                   /63 GAO/HEHS-99-187R
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This correspondence is based on data collected from and discussions with officials from
HHS; the American Red Cross and America’s Blood Centers, the major blood banking.
organizations; the American Association of Blood Banks, the professional and accrediting
organization for blood facilities and transfusion services; and the American Blood Resources
Association, representing the paid plasma collection industry. We carried out our work
between June and September 1999 in accordance with generally accepted government
auditing standards.

BACKGROUND

About 8 million volunteers donate approximately 12 million units of whole blood each year.
Sixty percent of the population is eligible to donate, and about 5 percent of the eligible
population actually donate each year.’ Whole blood is rarely transfused into patients.
Instead, each unit of whole blood is separated into specialized components, consisting of
various types of blood cells (for example, red blood cells and platelets) and plasma.

In addition to whole blood, approximately 370 plasma collection centers collect about 11
million liters of plasma from 1.5 million paid donors annually, involving a total of
approximately 13 million separate donations each year.’ Many different components of
plasma are used for medical treatment, ranging from treating the trauma of burns and surgery
to replacing blood elements that are lacking as a result of disease, such as hemophilia

There are four sources of whole blood from volunteer donors for transfusion. The first,
allogeneic donations, is the most important category, accounting for roughly 90 percent of
the blood supply. Blood from allogeneic donations is available to any patient in need, and
efforts to increase the blood supply usually focus on increasing participation in blood drives
or otherwise raising the number of allogeneic collections. Second, autologous collections
involve blood taken from patients before a medical procedure for their own use. Third,
directed collections involve blood donated for use by a particular patient. A small portion of
the autologous and directed collections ultimately are “crossed over” to the general supply.
Finally, less than 2 percent of the total blood supply is imported.3

Blood banks maintain a supply cushion to meet the uncertain demand for blood. Local
demand for particular blood types varies over the course of the year, and blood banks want
to ensure that trauma patients and others who may require many units of blood can be
treated promptly whenever the need arises. The supply cushion means that some blood is
discarded-in 1997, for example, about 4 percent of the allogeneic blood supply expired
without being transfused.

New variant CID, first identified in 1995, is a chronic, progressive neurodegenerative disease
that is inevitably fatal. It is believed that nvCJD is caused by infective proteins called prions.
As of August 1999, there were 43 confirmed cases41 in the United Kingdom, 1 in F’rance,
and 1 in Ireland. It is suspected that all of these individuals contracted nvCJD from eating
contaminated tissues from cattle infected with bovine spongiform encephalopathy (BSE) in

‘To be eligible to donate, a person should be at least 17 years of age, weigh at least 110pounds, be in
good physical health, and pass a physical and medical history examination.
‘Plasma is the liquid portion of blood, containing nutrients, electrolytes (dissolved salts), gases,
albumin, clotting factors, hormones, and wastes.
STechnically, allogeneic donations include all blood collected from one individual for use in another.
Thus, blood from directed donations and imported blood is also allogeneic, although those sources are
usually discussed separately.

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the United Kingdom, probably prior to 1990. Cattle herds in the United Kingdom suffered an
epidemic of BSE, which peaked in 1992 and subsequently declined as the result of
government actions to change the composition of cattle feed. Although nvCJD’s incubation
period is unknown, the disease may manifest itself long after the initial exposure-the
incubation period for other human prion diseases ranges roughly from 4 to 40 years.
Estimates of the number of U.K. residents who will ultimately manifest nvCJD range from the
hundreds to more than 500,000. In the United States, there have been no documented cases
of nvCJD and no confirmed cases of BSE in U.S. cattle.4

Hemochromatosis is the most common genetic disease in Americans of European descent-
about 1 in 10 may carry the gene for this disease, and as many as 1 million Americans have
evidence of hemochromatosis.5 However, the proportion of individuals who have mutations
associated with hemochromatosis and later develop the disease is unknown, because not all
of these individuals become ill6 Treatment of hemochromatosis has two phases: (1) iron
depletion therapy, in which the patient receives a therapeutic phlebotomy about 1 to 2 times
a week for several months up to 3 years to remove excessive iron stores, and (2)
maintenance therapy, in which the patient continues to undergo therapeutic phlebotomies
but less frequently (2 to 6 times a year) to keep body iron stores low and iron levels normal
for the remainder of the patient’s life.

RECENT TRENDS IN SUPPLY AND DEMAND

The blood supply has decreased over the last decade, and there is some evidence that in
recent years the demand for blood has increased. NBDRC, an affiliate of the American
Association of Blood Banks, recently projected that the demand for blood will outstrip supply
by next year. While the blood supply has tightened, current evidence indicates that the blood
supply has declined more slowly than NBDRC assumed. Projecting the future supply of and
demand for blood is inherently difficult because of the uncertain ability of the blood industry
to respond to potential shortages by increasing supply or reducing demand. Because blood
cannot be stored for long periods,’ blood banks have little incentive to collect more than is
needed, and they may be able to increase collections if required. Similarly, physicians and
blood transfusion centers may be able to use blood more judiciously, decreasing aggregate
demand.

Any conclusions about the trends in the blood supply are hampered because information
about the blood supply has not been gathered routinely at short intervals. Until 1995, the
National Institutes of Health (NIH) funded surveys of blood banks and transfusion centers.
In 1998, NBDRC conducted a privately funded survey that measured the blood supply in 1997.
NBDRC is expected to announce the results of a new survey of the blood supply (without
information about transfusions) in November 1999, and the National Heart, Lung, and Blood


4TheCentersfor DiseaseControl and Prevention (CDC) conducts surveillance for nvCJD. The
Department of Agriculture monitors cattle herds for BSE.
GFewerdata are available on the prevalence of hemochromatosisin other populations.
mere are two genetic mutations, C282Y and H63D, associated with the gene for hemochromatosis.
C282Y is considered the major mutation. Individuals who inherit one copy of C282Y or H63D do not
develop the disease although some may exhibit symptoms. According to a CDC offkial, an estimated
60 to 80 percent of individuals who have two copies of C282Y-one inherited from each parent-
eventually develop symptoms.
‘Red blood cells may be preserved as a liquid for up to 42 days. They also may be frozen for up to 10
years, but this is rarely done because it is prohibitively expensive.

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Institute of NIH recently arranged for NBDRC to collect data on blood donations on a
monthly basis from a sample of blood centers. In the future, NBDRC hopes to expand this
survey to collect information on transfusions as well.

Based on the results of its 1998 survey, NBDRC has projected that the demand for blood will
outstrip supply by next year.’ That projection rests on the overall 5.5 percent decrease in the
blood supply from 1994 to 1997 (see table 1) and on the observed 3.7 percent increase in the
number of units transfused-during those years.

Table 1: Blood Sunolv Trends




“Sum of units does not add exactly to total units in NBDRC data
bImported units totaled 285,000in 1989,206,OOO   in 1992,and 220,000in 1994. They were included in
the allogeneic total and not reported separatelyin 1997.

Source: E. L. Wallace and others, “Collection and Transfusion of Blood and Blood Componentsin the
United States, 1989,” Transfusion, Vol. 33 (1993), pp. 139114;E. L. Wallace and others, “Collection and
Transfusion of Blood and Blood Componentsin the United States,1992,”Transfusion,Vol. 35 (1995),
pp. 802-12;E. L. Wallaceand others, “Collection and Transfusion of Blood and Blood Componentsin
the United States, 1994,” Transfusion, Vol. 38 (1998), pp. 625-36;NBDRC; and GAO calculations.


Our analysis of blood supply data found that the blood supply decreased less than the 5.5
percent figure implies. The supply of allogeneic and imported blood decreased only 2.1
percent from 1994 to 1997, and the community supply-the blood available to anyone in need
(including crossed-over autologous and directed units)-decreased about 2 percent from
1994 to 1997 (see table 2). The supply designated for particular transfusion patients, both
autologous and directed, decreased by 37 percent from 1994 to 1997, accounting for two-
thirds of the overall 5.5 percent decline.’ As the general blood supply has become safer,
fewer patients have donated their own blood in advance of a procedure or requested that
friends or family members donate blood for them. However, some portion of these losses in
autologous and directed donations would have to be replaced by units from the allogeneic
supply for patients who previously would have had their blood needs met by autologous or
directed units.


*This projection did not consider the consequences of excluding travelers to the United Kingdom from
donating blood or of any other policy changes that may affect the blood supply.
“In particular, the number of autologous and directed units collected but not transfused dropped 63
percent between 1994and 1997.

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Table 2: Trends in the Communitv Sunnlv of Blood

    Supply source                             1989           1992         1994          1997
    Allogeneic    and imported units    13,224,OOO     12,241,OOO   11,993,ooo    11,741,000
    Total autologous    and directed     1,005,000      1,553,ooo    1,347,ooo       848,000
    units collected
                                                                                               I

    Autologous     and directed units     453,000        702,000       587,000       501,000
    transfused                              (45%)          (45%)         (44%)         (59%)
    Autologous     and directed units     480,000        789,000       678,000       251,000
    discarded, other                        (48%)          (51%)         (50%)         (30%)
    Autologous and directed units           72,000         62,000       82,000        96,000
    crossed-oveP                              (7%)           (4%)         (6%)         (11%)

    Total community supply              13,296,OOO     12,303,OOO   12,075,OCMl   11,837,OOO
    (allogeneic   and crossed-over)
    Change from previous survey                 -          -7.5 %       -1.9 %        -2.0 %
‘Units crossed-over are added to the general supply.

Source: E. L. Wallace and others, “Collection and Transfusion of Blood and Blood Componentsin the
United States, 1989”; E. L. Wallace and others, “Collection and Transfusion of Blood and Blood
Components in the United States, 1992”;E. L. Wallace and others, “Collection and Transfusion of
Blood and Blood Components in the United States, 1994”; NBDRC; and GAO calculations.


The number of units rejected on testing has decreased over this period because donors who
have diseases for which tests have been introduced have been removed from the donor pool
and because succeeding generations of tests have become more accurate, resulting in fewer
donors falsely testing positive for a disease. However, if a new test were introduced for some
disease, the number of units rejected could increase as donors testing positive for the
condition are screened out.

Trends in the number of units transfused support the view that the blood supply is not in
crisis (see table 3). Overall, the blood banking system had an adequate supply to meet
increasing demand. Total units transfused increased 3.7 percent from 1994 to 1997, and
allogeneic transfusions increased 7 percent in the same period. Between 1994 and 1997, the
proportion of units lost before transfusion decreased, and more directed donor and
autologous units were crossed-over to the conununity supply. However, the blood supply
cushion (percentage of units not transfused) also dropped sharply from 1994 to 1997.




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Table 3: Transfusion Trends

 Year                            Transfusions”          Percent of available supply
11989          I                     12,059,000 I                              89.0 I
 1992                                11,307,000                                85.9
 1994                                11,107,000                                86.0
 1997                                11,517,ooo                                93.1
‘Transfusions of whole blood or red blood cells.

Source: E. L. Wallace and others, “Collection and Transfusion of Blood and Blood Components in the
United States, 1989”; E. L. Wallace and others, “Collection and Transfusion of Blood and Blood
Components in the United States, 1992”;E. L. Wallace and others, “Collection and Transfusion of
Blood and Blood Components in the United States, 1994”: NBDRC; and GAO calculations.


Other evidence seems also to indicate that the blood supply cushion has narrowed, although
it is difficult to determine if shortages are worse now than in earlier years because blood
banks have no incentive to collect more blood than can be used. The American Red Cross
informed us that the number of days’ supply decreased below the comfort level in many of its
centers and gave us data showing less than 1 day’s supply on hand for some blood types in
some regions at one point this summer. America’s Blood Centers reported anecdotal
evidence of shortages in many of its affiliated blood banks this year. Shortages occur more
frequently in some regions, as do shortages of blood types 0 and B. Furthermore, the 1998
NBDRC survey found that at least some surgeries and medical procedures have been
postponed due to blood shortages. More specifically, 8.6 percent of the hospitals surveyed
indicated that elective surgeries were cancelled on 1 or more days in 1997 due to blood
shortages; 24.7 percent of hospitals said that they were unable to meet nonsurgical blood
requests on 1 or more days.”

Blood banks can mitigate the effects of local blood shortages by transferring blood from
regions with an excess supply to those with shortages. The American Association of Blood
Banks’ National Blood Exchange and the American Red Cross together moved about 1.1
million units of blood between blood centers last year. This blood is purchased by centers in
shortage areas from centers with surpluses of particular types of blood.

Estimates of the future demand for blood are uncertain. On the one hand, persons aged 65
and older receive twice as much blood per capita as younger individuals, so the aging of the
population may increase the demand for blood products. Further, some procedures requiring
blood are being performed with increasing frequency, and the range of treatments requiring
blood or blood products is increasing.” On the other hand, some evidence indicates that the
demand for blood can be reduced. For example, the amount of blood used for the same
procedures varies widely among hospitals, and at least one pilot program has shown that the
use of blood can be substantially reduced without affecting clinical outcomes. Similarly,


“‘Among all hospitals responding to the survey, the mean number of days with surgeries cancelled was
0.44 and the mean number of days with unmet nonsurgical blood requests was 2.1.
“For example, heart surgeries typically require 6 units of blood and 6 units of platelets, and bone
marrow transplants generally involve 20 units of blood and 120units of platelets. Among the
procedures requiring the greatest use of blood are the treatment of trauma patients, heart surgeries,
orthopedic surgeries, and some cancer treatments.

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improved surgical techniques and better understanding of the clinical thresholds that trigger
blood transfusions has reduced the demand for blood in some instances.‘2

One alternative being explored for handling issues of blood shortages and blood safety is the
development of blood substitutes. The goal is to develop substitutes for red blood cells that
are safe, not type-specific, have a longer shelf life, are readily available and in large
quantities, and would deliver oxygen therapeutically and quickly to tissues and organs. Some
products in development include hemoglobin-based oxygen carriers and perfluorocarbons.
However, most products are still in the early stages of research and development. While
some of these products have reached clinical trials, their future contribution to the blood
supply cannot be predicted. For example, the half-life of one company’s product is 12 to 48
hours, which is less than the go-day half-life of fresh red blood cells. Because it will take at
least several years for an artificial blood alternative to reach the market, blood substitutes
will not be available to meet blood needs in the short-term.

These data on the blood supply only address supply trends for whole blood. According to the
American Blood Resources Association, plasma collections have also decreased-
approximately 10 to 15 percent in recent years. Some of the factors affecting blood
collection overall, such as changes in the donor pool, have also had an effect on plasma
collections. While plasma donors are paid for their donations, the $25 to $30 payment may no
longer be worth the time and inconvenience of plasma donation. Nevertheless, the American
Blood Resources Association does not foresee any crises in the plasma supply in the short-
term. Association officials estimate that about 30 percent of the plasma collected in the
United States is currently exported, but it is unclear whether some of that plasma could be
reallocated to meet shortages in this country, should they occur

HHS recently organized an interagency committee to develop strategies for increasing the
blood supply. The group recommended that (1) the blood supply be monitored on an
ongoing basis, (2) steps be taken to encourage more donations by current blood donors, (3)
donor relations be improved to facilitate therecruitment and retention of donors, (4)
restrictions be removed to safe donations from individuals currently disqualified from
donating, and (5) economic issues facing the blood industry be addressed. HHS has already
agreed to fund, through NIH, monthly surveys of the blood supply to be conducted by
NBDRC, and the Department reported that specific initiatives in each of the other areas are
under way. For example, NIH is conducting research to find ways to increase the number of
donations by regular blood donors.

EXPECTED EFFECT OF EXCLUDING
DONORS WHO HAVE RESIDED OR
TRAVELED IN THE UNITED KINGDOM

FDA has issued guidance recommending that collections be prohibited from donors who had
resided or traveled in the United Kingdom for a total of 6 months or more between 1980 and
1996 because of the theoretical risk of n&ID being transmitted through blood transfusions.


‘“Paul C. Hebert and others, “A Multicenter, RandomizedControlled Clinical Trial of Transfusion
Requirements in Critical Care,” New England Journal of Medicine, Vol. 340, No. 6 (1999),pp. 409-17.
In addition, the use of drugs that stimulate blood-cell production and techniques such as intraoperative
blood salvage and preoperative and intraoperative hemodilution can reduce the need for transfusions.


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FDA will review this policy at 6-month intervals to consider any new scientific information
and the policy’s impact on the blood supply.

It has not been shown that nvCJD is transmissible by blood transfusion. However, animal
research suggests that infection by blood is theoretically possible-in some cases, direct
injection of blood from a contaminated animal into the brain of another has caused infection.
Yet no cases of transmission by blood in humans have been documented. In the United
Kingdom, 4 donors subsequently diagnosed with nvCJD gave blood that was transfused into
10 recipients. None of these recipients have developed nvCJD to date, although they may
later because of the long incubation period. Blood is still collected and transfused in the
United Kingdom. However, because it is possible that infectious agents are concentrated in
white blood cells, leukofiltration to remove white blood cells is being introduced for all
whole blood collections.

In June 1999, FDA’s Transmissible Spongiform Encephalopathy Advisory Committee
recommended that the agency prohibit blood donations by persons who had resided or
traveled in the United Kingdom. The committee members were polled for their
recommendations on the duration of residence that should trigger the ban. The median
recommendation was for 6 months, with another cluster of votes at 1 year. One week later,
the HHS Blood Safety Committee, chaired by the Assistant Secretary for Health and Surgeon
General, unanimously endorsed this recommendation and selected 6 months as the trigger
for the exclusion. In August 1999, FDA issued industry guidance for implementing this
recommendation.13

In making its recommendation, the FDA advisory committee tried to balance the twin goals
of minimizing losses to the blood supply and eliminating as much risk as possible. A survey
of blood donors done for the committee by the American Red Cross found that 23 percent of
donors had traveled to the United Kingdom between 1980 and 1996. A previous survey of
U.S. blood donors found that 1.7 percent of them traveled to the United Kingdom each year, a
figure #at is close to the results of a Department of Commerce survey that estimated that 1.4
percent of Americans traveled to the United Kingdom in 1997. Only one-fifth of the blood-
donor travelers had been in the United Kingdom for more than 30 days, and just 1 in 10 of
them had a cumulative stay of 5 months or more. The Red Cross analysis estimated that the
6-month exclusion criterion would result in a 2.2 percent reduction in the blood supply and
eliminate 87 percent of the risk of collecting blood from a person infected with nvCJD.

Estimates of the degree of risk reduction achieved by this exclusion are problematic for
several reasons. First, the degree of potential risk to be mitigated is unknown. Second,
because the prohibition applies only to future donations, some blood from donors who would
now be excluded has entered the blood supply in the recent past. Third, because so little is
certain about how nvCJD is acquired, estimates of the beneficial effect of any prohibition
threshold-other than a complete ban on potential donors who have traveled to the United
Kingdom at all-are uncertain. For example, the Red Cross estimate assumed that the risk of
acquiring nvCJD increased directly with each day spent in the United Kingdom; therefore,
any change in this assumed relationship would lead to a significantly different risk reduction
estimate. Indeed, HHS told us that it did not totally agree with the Red Cross risk
formulation and that its choice of the 6-month threshold was based on other information. In
particular, HHS told us that in each of the British cases (41 of the 43 known cases), the
individual was born in the United Kingdom and resided there for at least 10 years between


“Canada implemented this donor exclusion policy at the same time.

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1980 and 1996; thus, ?3HS reasoned that any exclusion threshold of 1 year or less would
reduce the presumed risk by tenfold or more.

Blood banks have expressed concern that this exclusion will eliminate more than 2.2 percent
of the blood suppl~.‘~ First, there is the possibility that some potential donors will fail to
attend to the details of the exclusion policy and decide not to donate blood even though they
are eligible to do so. For example, eligible individuals who visited the United Kingdom for
less than 6 months between 1980 and 1996 might not consider donating blood because they
had heard that visitors to the United Kingdom should not give blood. One possible, although
unlikely, illustration of the potential impact of this exclusion is an analysis of data from the
American Red Cross survey that found 15 percent of the blood supply would be lost if all
travelers to the United Kingdom for at least 1 week between 1980 and 1996 did not donate.
There is also concern that potential donors who have not traveled to the United Kingdom
may become discouraged because their friends or neighbors are excluded, heightening the
sense that it is difficult to pass all the screening criteria for giving blood. Finally, there is
concern that excluded U.K. travelers will not return to donate blood if, and when, the
restriction is lifted.

Blood banks are also concerned about other burdens imposed by this exclusion. For
example, according to research conducted by the American Red Cross, donors who resided
or traveled in the United Kingdom are disproportionately repeat donors. Without these
donors, the blood banks will need to recruit a large number of first-time donors to replace
them because first-time donors are roughly twice as likely to.have disqualifying medical
conditions as regular donors. In addition, not all new donors become regular donors. The
effect will vary by blood center, as those with a larger proportion of U.K. travelers will lose
more of their donors than other blood collection centers. The Red Cross survey found that
the proportion of donors affected in some blood centers were 35 percent greater, and others
50 percent less, than the overall average.

POTENTIAL FOR BLOOD DONATIONS FROM
INDMDUAIS WITH HEMOCHROMATOSIS

One measure being considered to alleviate potential shortages in the blood supply is a change
in policy to allow blood collected from hemochromatosis patients to be distributed for
transfusion.‘5 Individuals with hemochromatosis have their blood drawn in a procedure
called therapeutic phlebotomy’6 to alleviate excess iron in their blood. Making
hemochromatosis patients eligible to donate would essentially provide an increased number
of donors because they have to periodically have blood drawn to treat their condition.
However, FDA is concerned that these individuals would not truthfully answer donation
screening questions about risk factors that would disqualify them, since they could avoid the

“‘American Blood Resources Association officials estimate that the exclusion of donors who have
traveled to the United Kingdom between 1980and 1996will result in a loss of approximately 1 percent
of current plasma donors.
%emochromatosis is a disease of iron regulation that results in excessive iron absorption and
accumulation, leading to organ damage. The human body cannot excrete excess iron, so it remains in
the body unless it is lost through menstruation, childbirth, hemorrhage, or blood donation. Iron is
highly toxic when an excessive amount is absorbed. Some clinical chronic conditions associated with
hemochromatosis include severe fatigue, diabetes mellitus, heart disease, cirrhosis of the liver, and
cancer.
‘??herapeutic phlebotomy is the removal of a full unit of blood from an individual, about 500 mls, for
the purpose of treating a disease.

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cost of paying for the therapeutic phlebotomy procedure by donating blood. In April 1999,
the Public Health Service’s Advisory Committee on Blood Safety and Availability
recommended that HHS change its policies and remove any barriers to the use of this blood
since there is no evidence that blood from hemochromatosis patients carries an increased
risk to recipients. At the same time, the commit-tee recommended that HHS take steps to
eliminate any financial incentive for hemochromatosis patients to donate blood.

According to a survey of 2,362 individuals with hemochromatosis, most individuals are
insured or partially insured for therapeutic phlebotomies; however, the average cost of the
procedure per unit of blood ranges from $52 at blood centers to $69 at physician offices and
$90 at hospitals, with an average out-of-pocket cost of $45 for all respondents to the survey.17
Even though therapeutic phlebotomies are necessary medical treatment for some individuals
with hemochromatosis, insurance does not always cover the costs. Out-of-pocket costs are a
financial incentive for persons with hemochromatosis to not disclose any disqualifying
conditions and volunteer for blood donations. In one study, 37 percent of the
hemochromatosis patients surveyed reported being voluntary donors before their diagnosis
and 54 percent of the individuals attempted to donate blood after diagnosis.‘*

FDA permits the use of blood from individuals with hemochromatosis as long as they meet
the same donor suitability criteria as any other donor, but it requires that this blood be
labeled as coming from a hemochromatosis donor, which effectively impedes the use of this
blood. Although hemochromatosis is inherited, not transmitted, and there is no evidence that
the use of hemochromatosis blood for transfusion carries any risks to the recipients,”
hospitals and physicians hesitate to use this blood. Some experts in favor of using blood
from individuals with hemochromatosis argue that Sweden and Canada have been
transfusing such blood for years without any problems. Still, a series of tests or studies may
be needed before the blood can be added to the blood supply. For example, in Ontario,
Canada, patients are first referred to physicians for exhaustive studies before the physicians
refer them back to blood centers to donate blood. Some in the U.S. blood industry consider
hemochromatosis donors to be the same as paid donors, implying a decreased level of
safety.2o FDA is similarly concerned that hemochromatosis patients who donate blood rather
than pay for a therapeutic phlebotomy will not respond to screening questions truthfully in
the absence of any change in the reimbursement policies for their treatment. In 1996, the
American Association of Blood Banks issued standards discouraging transfusion of blood
from donors who had therapeutic phlebotomy. Because many blood centers conform to
these standards, this policy effectively excludes most individuals with hemochromatosis
from blood donation; in the United States, the blood obtained by therapeutic phlebotomy
from hemochromatosis patients is, at present, discarded.

While HHS is Considering options for removing barriers to the use of this blood for
transfusion, it is unclear how much a change in policies on blood horn hemochromatosis
patients would impact the blood supply. Most centers unknowingly use hemochromatosis
blood because they do not know at the time it is donated that it came from an individual with
hemochromatosis. In most of these cases, even the individuals donating the blood are not

17S.M. McDonnell and others, “A Survey of Phlebotomy Among Persons With Hemochromatosis,”
Transfusion, Vol. 39 (1999), pp. 651-6.
“S. M. McDonnell and others, “A Survey of Phlebotomy Among Persons With Hemochromatosis.”
?he processing of whole blood units into packed red cells removes most of the iron-enriched serum.
“Data show that blood from paid donors is more likely to transmit disease than that from volunteer
donors; R. A. Sacher, “Hemochromatosis and Blood Donors: A Perspective,” Transfusion, Vol. 39
(1999), pp. 551-4.

 10                                                 GAOLHEHS-99-187R Availability      of Blood
B-283557

aware that they have hemochromatosis, but some individuals do donate even after diagnosis.
The results from the National Donor Research and Education Study sponsored by NIH show
that about half of the individuals who responded that they had hemochromatosis (only 0.4
percent of those surveyed) were volunteer donors. At present, there is no routine screening
for hemochromatosis, and blood banks cannot easily detect hemochromatosis blood because
they test hemoglobin, not iron status of the donor. Therefore, the potential gain to be
achieved by encouraging donations from individuals with hemochromatosis will be limited by
the extent to which such individuals are already donating blood.

The American Red Cross estimates that some 4,000 phlebotomies were conducted for
patients with hemochromatosis in the Red Cross system in 1998, and 5,000 such
phlebotomies were conducted in 1999. America’s Blood Centers does not have aggregate
data across its member centers, but one of its centers performs about 600 therapeutic
phlebotomies per year for individuals with hemochromatosis. However, America’s Blood
Centers does not know if all these individuals would be eligible to donate blood. Data from
the American Red Cross and America’s Blood Centers represent only a minority of
therapeutic phlebotomies performed each year. One study showed that about two-thirds of
the individuals diagnosed with hemochromatosis are phlebotomized in a hospital or in a
physician’s office; the re maining one-third are phlebotomized at a blood center.‘l

There have been attempts to estimate the number of units of blood that would be available if
hemochromatosis blood were used for transfusion, but the range is wide-300,000 units to 3
million units. The upper value, 3 million units, is an overestimation. It is based on the
estimated prevalence of individuals in the United States with the major mutation associated
with hemochromatosis, and an estimate of the number of therapeutic phlebotomies these
individuals may require annually (six units per patient per year), with the assumption that
half of these patients would require phlebotomies. However, not all such persons will be
eligible to donate and not all units will be suitable for transfusion. Some experts believe
300,000 units is more accurate, although this may be a conservative estimate, since the
number includes only blood drawn during the maintenance phase of treatment. Additional
blood from eligible individuals undergoing iron depletion therapy and from other
hemochromatosis patients who require therapeutic phlebotomy may increase somewhat the
potential supply of blood available for transfusionzl

In April 1999, members of the Advisory Committee on Blood Safety and Availability
concluded that while blood products from individuals with hemochromatosis carry no known
increased risk to recipients, financial incentives for blood donation must be removed before
blood from these individuals can be added to the blood supply. Initially, HHS considered
options for the Health Care Financing Administration (HCFA) to provide reimbursement for
all therapeutic phlebotomies. However, HCFA determined that it did not have statutory
authority to provide universal coverage. HCFA finances care for the Medicare population,
has limited authority over Medicaid, and no regulation of the uninsured. Because most blood
donors are under 65, they would not fall under Medicare. Thus, it seems unlikely that the
issue of financial incentives for blood donation will be quickly addressed. The blood
collection centers would have to cover the costs of therapeutic phlebotomies for all
individuals with hemochromatosis if they want FDA to revise current regulations that affect
the use of blood from these individuals. While blood centers may be able to recover these
costs by selling blood from individuals with hemochromatosis, a question remains whether

‘IS. M. McDonnell and others, “A Survey of Phlebotomy Among Persons With Hemochromatosis.”
=Other hemochromatosis patients would include carriers.

11                                                GAWHEHS-99-187R Availability of Blood
B-283557

they would cover all therapeutic phlebotomies regardless of the suitability of the blood for
transfusion.

FDA has agreed to make the necessary regulatory changes to remove the barriers to donation
once the financial incentives for hemochromatosis patients to avoid paying for therapeutic
phlebotomies are removed.23 There are several different requirements that would need to be
changed. FDA currently requires an 8week interval between donations to prevent iron
depletion of donors, but individuals with hemochromatosis at the initial stage of treatment
undergo therapeutic phlebotomies 1 to 2 times a week. FDA also currently requires blood
from therapeutic bleeding, including for hemochromatosis, to be labeled with the disease for
which the bleeding was performed, which discourages health care providers from using this
blood.

As an initial step, FDA recently agreed to consider case-by-case exemptions to existing
regulations on blood labeling and frequency of blood collection for blood establishments that
can verify that therapeutic phlebotomy for hemochromatosis is performed at no expense to
the patient. However, FDA officials have publicly stated that, in making these exemptions,
they will require a commitment from the blood collection facilities to concurrently provide
safety data, including viral marker rates, incidence of transmissible infections based on
seroconversion rates, frequency of post-donation reports of undisclosed risks, and reports of
adverse events.

Individuals with hemochromatosis have the potential to make up some of the loss in blood
donations due to the exclusion of donors who have resided or traveled in the United
Kingdom for a total of 6 months or more between 1980 and 1996. However, changes to
current regulations affecting blood from hemochromatosis patients will occur considerably
later than FDA’s recent guidance to exclude donors, which has already gone into effect. The
issue of coverage for therapeutic phlebotomies has yet to be resolved. HCFA has limited
authority beyond Medicare, and anything less than full reimbursement may be considered
undue donor incentive. Therefore, unless the blood establishments are willing to absorb the
costs of providing phlebotomies to persons with hemochromatosis, it is unlikely that changes
in regulations will occur.




“STheAmerican Association of Blood Banks has also indicated that if FDA makes changes, it would
make changes to its standards related to the use of blood from patients with hemochromatosis, so that
centers could remain in compliance with the association’s requirements.

 12                                                  GAO/HEHS-99-187R Availability of Blood
B-283557

AGENCY COMMENTS

We received comments from HHS on a draft of this report. HHS generally concurred with
our description of the issues and provided technical comments, which we have incorporated
where appropriate. HEIS also said that it would not be possible to fully describe the basis for
its decision to recommend excluding blood donors who had resided in the United Kingdom in
a report with this limited scope. We believe that the report fairly characterizes the major
reasons for that decision.

As agreed with your office, unless you publicly announce its contents earlier, we plan no
further distribution of this report until 30 days from the date of this letter. At that time, we
will send copies to the Honorable Donna E. Shalala, Secretary of HHS, and other interested
parties. We will make copies available to others upon request.

Major contributors to this report were Marcia Crosse, Martin T. Gahart, and Angela Choy.
Please contact me at (202) 512-7119 if you have any questions.

Sincerely yours,




‘J&et Heinrich
Associate Director, Health F’inancing
  and Public Health Issues




(101864)


13                                                GAOEIEHS-99-187R Availability of Blood
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