Public Health: Blood Supply Generally Adequate Despite New Donor Restrictions
Published: 2002-07-22T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: According to the American Association of Blood Banks, every year about 8 million individuals donate 14 million pints of blood, and 4.5 million patients receive life saving blood transfusions. The available data indicate that the blood supply has increased in the last 5 years and that growth has kept pace with the rise in demand. Blood suppliers received a high volume of blood donations immediately after the September 11 attacks. However, the small amount of blood needed to treat survivors of the attacks resulted in a nationwide surplus. The nation's blood supply can compensate for donors lost because of new donor restrictions designed to further reduce the risk of variant Creutzfeldt-Jakob Disease transmission. The average price of blood has risen over 50 percent since 1998. Although blood is primarily collected from volunteers, blood suppliers incur costs by collecting, processing, and testing donated blood.

section_title: Letter
paragraphs: The terrorist attacks of September 11, 2001, reminded the nation of the  critical importance of a safe and adequate supply of blood for transfusions.   Every year, about 8 million individuals donate roughly 14 million pints of  blood, and approximately 4.5 million patients receive life-saving blood  transfusions, according to the American Association of Blood Banks  (AABB). Efforts to understand supply and demand trends have coincided  with renewed debate about ensuring the safety and availability of blood.   Such concerns are evidenced in new Food and Drug Administration (FDA)  guidance for organizations that collect, process, and distribute blood,  which is aimed at reducing the possible risk of transmitting variant  Creutzfeldt-Jakob Disease (vCJD), the human form of bovine spongiform  encephalopathy (BSE), or “mad cow” disease, through transfusion.  These  “donor deferrals,” or exclusions, prevent individuals from giving blood if  they have traveled extensively in the United Kingdom or Europe, thereby  reducing the supply of donors.  Adding to safety and availability concerns is  the sharp rise in the cost of blood in recent years, partly the result of new  measures for testing and processing donated blood to identify viruses and  reduce adverse transfusion reactions.  These issues, coupled with a  historically sporadic monitoring of the blood supply, have led to questions  about U.S. blood suppliers’ ability to respond to emergencies.
You asked us to address the following objectives regarding the availability  and safety of the U.S. blood supply:  determine the adequacy of the current blood supply and describe recent  trends in supply and demand,   describe blood suppliers’ response to the September 11 terrorist attacks  and their planning for future emergencies,   evaluate the potential impact of the new vCJD donor restrictions on the  U.S. blood supply, and   describe recent changes in the price of blood.
To address these objectives, we measured supply and demand trends  before and after September 11 by obtaining national data on the collection  and distribution of blood from the National Blood Data Resource Center  (NBDRC), a nonprofit research group, and the two major national blood  suppliers—the American National Red Cross and America’s Blood Centers  (ABC).  We attended FDA and Department of Health and Human Services  (HHS) blood advisory committee meetings that reviewed blood suppliers’  response to the September 11 terrorist attacks and interviewed  management at the Red Cross and ABC to determine how much blood was  collected and distributed in response to the attacks.  In addition, we  reviewed current scientific literature, FDA advisory committee  recommendations, FDA guidelines, and blood supplier forecasts regarding  the development and potential impact of the vCJD deferral policies.  To  analyze recent changes in the price of blood, we reviewed data from ABC  and the Red Cross as well other studies of these price changes.  To address  the four objectives, we interviewed officials at HHS’ Office of Public Health  Science (OPHS); the Centers for Disease Control and Prevention (CDC)  National Center of Infectious Disease; the National Institutes of Health  (NIH), National Heart, Lung, and Blood Institute; FDA’s Office of Blood  Research and Review; and the Department of Defense (DOD), Armed  Services Blood Program Office.  We conducted our work from May 2001  through June 2002 in accordance with generally accepted government  auditing standards.
subsections: section_title: Background
paragraphs: About 90 percent of the U.S. blood supply is collected by two suppliers— the American Red Cross and independent centers affiliated with ABC.   Generally, suppliers collect, test, and process blood and sell it to health  care providers.  FDA is responsible for ensuring the safety of the U.S. blood  supply, which it does by inspecting blood collection procedures and  enforcing federal regulations.  Although past monitoring efforts by industry  and nonprofit groups have examined supply and demand trends for blood,  current efforts are focused on providing daily monitoring of hospitals’  blood inventories.
subsections: section_title: Blood Collection and Use in the United States
paragraphs: In the United States, about 8 million volunteers donate approximately 14  million units of whole blood each year.  Sixty percent of the population is  eligible to donate blood, but in any given year only about 5 percent of those  who are eligible actually do so. Eighty percent of donors are repeat  donors.  A typical donor gives blood approximately 1.6 times a year, but  donors may give 6 times a year, or every 8 weeks, which is the period the  body needs to replenish red blood cells.  The Red Cross and ABC each  collect about 45 percent each of the nation’s blood supply, and roughly 10  percent is supplied by other independent blood centers, DOD, and  hospitals that have their own blood banks.
Most hospital transfusion services purchase blood and blood components  under a contract with a local supplier which describes the price and  quantity of blood to be delivered.  Blood suppliers use resource-sharing  programs to help suppliers in high-demand areas buy blood that is not  needed by the supplier that collected it.  Taken together, the Red Cross,  ABC, and AABB’s National Blood Exchange moved about 1.4 million units  of blood—over 10 percent of the nation’s supply—among suppliers in 2000.   In addition, the Red Cross has a nationwide inventory control system to  facilitate the movement of its surplus blood.
Donated blood is tested for blood type (A, B, AB, and O) and Rh type  (positive or negative). Donors with type O Rh negative blood are known as  “universal donors,” since it can be given to patients of any blood type in an  emergency. Donated blood is also screened for a number of diseases and  other elements that could prevent its use.  For example, blood is tested for  red blood cell antibodies that may cause an adverse reaction in recipients  and screened for hepatitis viruses B and C, human immunodeficiency  viruses (HIV) 1 and 2, other viruses, and syphilis.  Most U.S. blood products  are now filtered to remove a class of cells known as leukocytes (white  blood cells), which have been implicated in adverse transfusion reactions.   Each unit of whole blood is separated into specialized components, or  “products,” consisting of various types of blood cells, plasma, and special  preparations of plasma.  Health care facilities transfuse the resulting 26.5  million components into about 4.5 million patients per year.
Red blood cells may be stored as a liquid for up to 42 days.  Blood banks  maintain a supply cushion to meet the uncertain demand for blood.  This  means that some blood is discarded; for example, from January through  August 2001, about 2 percent of the blood supply expired without being  transfused.  Red blood cells can also be frozen and stored for later use.   The military makes extensive use of frozen blood inventories to meet  wartime contingencies, maintaining stocks of frozen type O units that can  be transferred into most patients regardless of their blood types.  However,  because freezing and thawing blood is expensive and labor intensive,  civilian blood centers maintain relatively small inventories of frozen blood,  primarily of rare blood types.  A new device approved by FDA in May 2001  may make frozen blood more useful in the future—it can extend the shelf  life of thawed, previously frozen blood from 24 hours to 14 days.
There are several ways for hospitals to reduce the amount of blood they  use.  For example, one large hospital we contacted was able to save $1 million and 10,000 units of blood over 8 years by promoting awareness  of blood use among physicians and by improving how blood is ordered and  used during surgeries.  A recent study of blood use during neurosurgery at  a large teaching hospital found that, because the hospital’s system for  ordering blood had not kept pace with advancements in surgical  techniques, physicians ordered 5.5 times more blood than was transfused  during surgery. One multifaceted approach to blood conservation is  known as bloodless surgery.  This practice involves the use of  pharmaceuticals that stimulate the production of red blood cells, surgical  equipment that cleans and returns lost blood to the patient, and  intravenous solutions that maintain blood volume. During a pilot study of  bloodless surgery techniques, one hospital successfully used these  techniques instead of blood transfusions for several hundred surgical  patients.
Federal Regulation of Blood The Public Health Service Act (PHSA) and the Federal Food Drug and  Cosmetic Act form the basis of the Public Health Service’s authority, as  enforced by FDA, to ensure the safety of blood that is collected and  transfused in the United States.  PHSA requires that all blood and blood  components distributed in interstate commerce be licensed by FDA in  order to ensure that the products are safe and effective.  Under PHSA,  FDA can recall blood and blood components that present an imminent or  substantial hazard to public health.  The licensing and regulatory standards  set by FDA attempt to maintain a blood supply that is both adequate and  safe.  Blood suppliers routinely take safety precautions beyond those  required by FDA.  For example, although FDA has not required nucleic acid  testing (NAT), a sophisticated test to detect HIV and hepatitis C virus  (HCV), virtually all blood centers perform it. Similarly, FDA has not  mandated universal leukoreduction, but most blood centers have adopted  the practice.
When suppliers violate regulations, FDA takes legal action to prevent  further violations.  These legal actions can result in the parties entering into  consent decrees of permanent injunction to comply with all applicable  blood safety rules.  Several blood and plasma suppliers as well as  manufacturers of blood testing supplies are currently under consent  decrees for various violations.  One of the most significant of these  agreements now in force is with the Red Cross, which entered into a  consent decree in 1993, after FDA discovered that the Red Cross had  failed to follow its own standard operating procedures, had deficiencies in  its quality control processes, and had committed other violations.
FDA has no authority to determine the amount of blood that should be  collected or to compel suppliers to make products available.  However,  FDA recognizes that an insufficient blood supply is a public health risk, and  it can make certain recommendations within its authority under PHSA and  the Federal Food, Drug and Cosmetic Act, as amended, related to the  availability of blood during public health emergencies.  In an emergency,  FDA and other HHS agencies can give advice to blood banks on prioritizing  the use of blood and facilitating the shipment of existing inventory to the  areas affected. For example, after the September 11 attacks, FDA issued  emergency guidelines to speed the delivery of blood to areas affected by  the attacks.  The guidelines allowed donated blood to be shipped to crisis  areas before NAT was completed and to allow clinical staff who were not  trained in all procedures to collect blood, in order to supplement the fully  trained staff. FDA’s emergency guidelines were rescinded on September 14, 2001, upon recognition that blood supplies were more than  adequate to address current needs.  HHS also can purchase blood and  blood components and make other arrangements to respond to threats to  the safety and sufficiency of the blood supply.
section_title: Monitoring the Blood Supply
paragraphs: While periodic surveys of the blood supply have been conducted for years,  no data on daily, weekly, or monthly national and regional blood collections  or usages were readily available to federal officials or blood suppliers until  2000.  NBDRC has conducted a biennial retrospective survey of blood  suppliers since 1997, and others conducted similar periodic surveys before  that.  NBDRC’s latest comprehensive biennial survey of blood supply and  usage measured all units collected and transfused in 1999.  In periods  between these biennial surveys, NBDRC conducts interim retrospective  studies that measure the pace and number of collections.  In addition, both  the Red Cross and ABC have reported their annual collections from 1996  through 2001.
Both the Red Cross and ABC have taken steps recently to improve the  measurement of blood collections and inventories in their own centers.   For example, the Red Cross recently introduced a large-scale, centralized  inventory tracking system.  This system monitors blood inventories and  distribution daily across all Red Cross blood centers, enabling projections  of demand and potential shortages using both daily data and historic blood  usage patterns.  Since March 2002, the independent blood centers affiliated  with ABC have participated in a less comprehensive daily inventory  reporting system.
In November 1999, HHS made a commitment to improve the monitoring of  the blood supply as part of its Blood Action Plan announced in 1998.  As a  first step, the HHS Office of the Assistant Secretary for Health and NHLBI  contracted with NBDRC to provide monthly data on supply and demand  trends using a statistically representative sample of 26 blood suppliers that  account for about one-third of U.S. blood collections.  Data from this  survey in 2000 indicated that the blood inventory was stable and that blood  banks were absorbing the impact of the first vCJD donor deferral better  than initially expected.  NHLBI terminated the NBDRC contract, and OPHS  assumed support for the NBDRC data collection effort through the end of  2001.  NBDRC has continued this data collection effort without public  funding.
Partly to compensate for the loss of the NBDRC data, OPHS introduced its  own early warning, or sentinel, system in August 2001.  The system is  designed to detect blood shortages that may adversely affect patient care  and analyze demand trends at transfusion centers and hospitals  nationwide.  OPHS collects daily blood inventory and use data from 26  hospitals and three transfusion centers that account for about 10 percent of  the national blood inventory.  Although the hospital sample is not  statistically representative, it includes both small and large hospitals in  different geographic regions of the United States meant to serve as  indicators of impending blood shortages.  To obtain supply data, OPHS has  also begun negotiations with ABC and the Red Cross to make available  daily supply data from their collection centers, although neither ABC nor  the Red Cross has yet agreed to do so.
First reported in 1996, vCJD is a progressive and invariably fatal  neurodegenerative disease, part of broader class of diseases known as  transmissible spongiform encephalopathies (TSE).  As of June 2002, there  were 130 individuals with confirmed or probable cases of vCJD: 122 in the  United Kingdom, 6 in France, 1 in the Republic of Ireland, and 1 in Italy. It is  suspected that these individuals contracted the disease from eating meat  from cattle infected with BSE (mad cow disease) in the United Kingdom  before 1990.  Cattle herds in the United Kingdom suffered an epidemic of  BSE that peaked in 1992 and subsequently declined as a result of  government actions to change the composition of cattle feed.  The  incubation period for vCJD is long, but its precise length is not known.   This makes it difficult to project how many people will ultimately become  ill.  The United States has one likely case of vCJD, a 22-year-old citizen of  the United Kingdom living in Florida who is thought to have acquired vCJD  in the United Kingdom.  There have been no confirmed cases of BSE in U.S.  cattle.
In response to the possibility that vCJD could be transmitted through blood  transfusions, in November 1999, FDA recommended deferring by April  2000 blood collections from individuals who had resided or traveled in the  United Kingdom for a total of 6 months or more from 1980 through 1996.    In recognition of the evolving BSE epidemic, FDA issued a more restrictive  policy in January 2002.
section_title: The Blood Supply Generally Is Adequate
paragraphs: Available data indicate that both blood collections and transfusions  increased substantially from 1997 through 2001.  While local and temporary  blood shortages have occurred periodically, the nation’s blood supply  generally is adequate.  Although blood collections increased nearly 40  percent in the weeks immediately following September 11, they since have  returned to pre-September 11 levels, following the pattern of collections  after other emergencies.  The inventory of blood in America’s hospitals was  at historically high levels before the surge in collections after September 11  and has remained adequate through the first 5 months of 2002.
subsections: section_title: Blood Supply and Inventory Trends Are Positive
paragraphs: Although no one data source has comprehensively tracked the nation’s  blood supply in the past, all of the sources we identified indicated that the  national supply has grown in recent years and was at historically high  levels before the surge in donations that occurred after September 11.   Annual blood collections have increased substantially—21 percent—since  1997, according to NBDRC measurements and estimates of annual blood  collections by all blood centers.  (See fig. 1.)  The number of units of blood  donated annually increased from 12.4 million in 1997 to an estimated 15  million in 2001.  (NBDRC estimated that 2001 collections would have  reached 14.5 million units, 17 percent higher than in 1997, without the post- September 11 surge.)  The increase in supply has kept pace with the  increase in the amount of blood transfused; for example, NBDRC data  indicated that the number of red cell units transfused rose 17 percent from  1997 to 2001, from 11.5 million to 13.5 million units, and the annual number  of units that were not transfused remained at about 1 million units, not  counting the post-September 11 surge.
Available data indicate that 2001 collections had risen even before the  increase in donations following September 11.  For example, the Red Cross  reported a 2.2 percent growth in total collections for the first 7 months of  2001 over the same period in 2000.  In addition, reflecting the success of a  Red Cross campaign to increase donations, the number of units collected at  Red Cross blood centers was 8 percent higher in July and August 2001 than  the number collected during the same period in 2000.  Similarly, NBDRC  reported that the 26 blood suppliers included in its statistically  representative national sample increased blood deliveries to transfusion  centers by 5 percent in May, June, and July 2001, compared with that period  in 2000.
The increased collections placed the inventories in America’s blood banks  at historically high levels just prior to the September 11 attacks.  The Red  Cross reported that its total red blood cell inventory was 33 percent higher  in August 2001 than it was in August 2000 and that its type O inventory was  83 percent higher than it was in August 2000.  The New York Blood Center  (NYBC) reported that it had a 4- to 5-day supply of blood on hand in early  September.  On September 10, 2001, the median inventory for the hospitals  in HHS’s Blood Sentinel Surveillance System for all blood types stood at  approximately 7 days, and for type O Rh negative blood, at 6 days.
section_title: Blood Collections Have Returned to Pre-September 11 Levels
paragraphs: In response to the perception that blood was needed to treat victims of the  terrorist attacks, Americans greatly increased their blood donations in the  weeks immediately after September 11.  NBDRC estimated that total blood  collections in the United States were 38 percent higher in September 2001  than average monthly collections earlier in 2001.  The Red Cross reported  that its national blood collections during the week of September 11 more  than doubled compared with the preceding weeks.  However, as with  previous disasters, the sharp increase in blood collections in response to  September 11 did not last.  While higher than usual blood collections  continued for several weeks after September 11, the number of units  collected had returned to the baseline level or slightly below it by the  beginning of November.
The post-September 11 pattern of collections mirrors the collections after  the April 19, 1995, bombing of the Edward R. Murrah Federal Building in  Oklahoma City. (See figs. 2 and 3)  Like the September 11 attacks, the  bombing of the Murrah building was a discrete event—there were not  continued attacks—and it became clear soon after the attack that a large  supply of blood would not be needed for the survivors.  The Oklahoma  Blood Institute (OBI), the primary blood supplier for the area, recorded a  nearly 45 percent increase in donations for April 1995 compared with the  previous month.  The spike included an increase in repeat donors and an 85  percent increase in first-time donors.  But collections rapidly returned to  their baseline level in May.
In contrast with the Oklahoma City bombing, the Persian Gulf War was  accompanied by a perceived need for blood that spanned a longer period.   OBI’s data recorded a sustained increase in donations for 3 months  beginning in November 1990, peaking in January 1991 at more than 25  percent higher than usual, and continuing through the end of the conflict in  February 1991.  But by March 1991, donations had returned to baseline  levels.
The limited information available to us indicates that blood collections  early in 2002 were roughly comparable to the levels immediately prior to  September 11.  For instance, the number of units collected in April 2002 by  the 26 blood centers in NBDRC’s sample was approximately equal to the  number collected in August 2001.  Similarly, the hospital inventories  measured by HHS’s Blood Sentinel Surveillance System in early May 2002  were similar to those levels measured just prior to September 11, 2001.
section_title: Blood Suppliers’ Response to September 11 Attacks Has Focused Emergency Planning on Maintaining Adequate Inventory
paragraphs: The high volume of blood donations made immediately after September 11,  and the very small amount of blood needed to treat survivors, resulted in a  national surplus—supply was substantially greater than needed for  transfusions.  Consequently, the proportion of units that expired and were  discarded in October and November 2001 was six times higher than the  proportion that expired on an average 2-month period in early 2001.  Blood  suppliers and the federal government are reevaluating how blood is  collected during and after disasters to avert the large amounts of blood that  went unused and the logistical strains of collecting unneeded blood.  A task  force of federal and blood supply officials has been created to coordinate  blood suppliers’ response to future disasters.  Incorporating the lessons  learned from past disasters, the task force has recommended that blood  banks focus on maintaining a consistently adequate nationwide inventory  in preparation for disasters and not collecting more blood after a disaster  than is medically necessary.
subsections: section_title: Response of Blood Suppliers to September 11 Had Unintended Consequences
paragraphs: America’s blood banks collected an unprecedented amount of blood in a  short period after the September 11 attacks.  HHS, ABC, and the Red Cross  all issued requests for blood donations, although HHS and ABC quickly  stopped issuing requests when it became clear that there were few  survivors of the attacks and there was a limited additional need for  transfusions.  Many blood suppliers were reluctant to turn away potential  donors, and some hospitals that did not have their own blood banks  responded to the surge in volunteers by collecting blood anyway.  This  surge of donors stressed the collection system.  Shortages in blood  collecting supplies, phlebotomists (technicians trained to collect blood),  and storage capacity occurred as more potential donors arrived.  Long  waiting lines developed because there was insufficient staff to draw blood.
Far more blood was collected immediately after September 11 than was  needed by survivors or than ultimately could be absorbed by the nation’s  blood banks.  Estimates of the number of additional units collected  nationwide range from 475,000 to 572,000, and fewer than 260 units were  used to treat victims of the attacks.
A portion of this additional supply went unused, expired, and was  discarded.  The Red Cross reported that its collections peaked from  September 11 through October 14, and that 5.4 percent of the blood it  collected during that time went unused and expired.  ABC officials told us  that its affiliated blood banks discarded approximately 4 percent of the  blood they collected after September 11, although the officials cautioned  that the figures reported to them by their independent centers might have  underestimated the number of units that expired.  NBDRC’s monthly  survey of a nationally representative sample of 26 blood suppliers found  that a higher percentage of units were outdated.  NBDRC reported that  about 10 percent of the units collected in September and October by the  suppliers it surveyed were outdated and discarded.  This was nearly a five- fold increase in the proportion of units these suppliers outdated and  discarded in the first 8 months of 2001—about 2 percent of their  collections, on average.  On the basis of NBDRC’s figures, we estimate that  approximately 250,000 units of blood were outdated and discarded in  October and November 2001; this is nearly six times the estimated 42,000  units discarded in an average 2-month period earlier in 2001.  All of these  figures may underestimate the total number of expired units, since they  represent expirations at blood suppliers only and do not capture units that  may have expired in hospital inventories.
Increased errors in the collection process at some blood banks  accompanied the surge in donations.  As much as 20 percent of some blood  banks’ donations were collected improperly and had to be discarded,  primarily because individuals had not completed the donor questionnaire  correctly. Some blood banks also suffered serious financial losses, as they  incurred the costs of collecting and processing units of blood they could  not sell.  For example, NYBC claimed it lost from $4 million to $5 million  and suffered a nearly three-fold increase in the number of units it had to  discard when blood donated in response to the attack expired.
section_title: Efforts to Improve Disaster Readiness Have Begun
paragraphs: Since September 11, federal public health agencies and blood suppliers  have found fault with their responses to prior disasters and begun to plan  for a more effective response to future emergencies.  Through an  interorganizational task force organized by AABB in late 2001, the focus  has begun to shift away from increasing blood collections in an emergency  to maintaining an adequate inventory of blood at all times.  This shift was  prompted by the realization that a surge in blood collections following a  disaster does not help victims because disaster victims rarely require many  units of blood and because newly collected blood cannot be used  immediately.  For example, as with September 11, only a small percentage  of the additional blood collected after the Oklahoma City bombing was  transfused into victims (131 units of more than 9,000 units collected).   Moreover, the units used to treat victims in the hours after a disaster are  those already on hand at the treating hospital or local blood bank. It takes  2 days to completely process and test a unit of newly donated blood, so  existing stores of blood must be used to treat disaster casualties.  Finally,  military experts and blood industry officials told us that it is unlikely a  discrete disaster scenario would require more blood than is normally  stored in the nation’s blood inventory.  They noted that large amounts of  blood have not been needed in building collapses (like the September 11  attacks and the Oklahoma City bombing), nor would blood transfusions be  a likely treatment for illnesses caused by a bioterrorism attack.
The AABB task force report made recommendations for the emergency  preparedness of the blood supply that were adopted by the HHS Advisory  Committee on Blood Safety and Availability. The recommendations are  aimed at having federal and other organizations that are involved in the  collection or use of blood coordinate their actions in an emergency.  For  example, the task force recommended the designation of all blood banks as  suppliers of blood in an emergency and that the Assistant Secretary for  Health serve as the spokesperson for all organizations involved in  managing and transporting blood in an emergency.  The task force also  recommended that it act as the coordinating group during emergencies to  assess the medical needs of victims for blood.
Both the Red Cross and ABC are independently pursuing their own plans to  meet emergency and long-term needs.  The Red Cross expects to increase  annual collections by 9 percent during each of the next 5 years.  The Red  Cross also plans to implement a “strategic blood reserve” within the next 5  years using preregistered donors and a limited stock of frozen blood cells.   ABC has established a “national strategic donor reserve” through which it  can call on the donors it has registered, if needed.
section_title: Blood Centers Can Compensate for Donors Lost Because of New Donor Exclusion Policy
paragraphs: In response to the increased incidence of BSE in the cattle herds of many  European countries, FDA, the Red Cross, and DOD are prohibiting blood  donations from a greater proportion of individuals who have resided in  countries where there is a risk of acquiring vCJD by eating contaminated  meat.  FDA estimates that its new deferral policy will further reduce the  risk of possible exposure to vCJD by 23 percent but that it will disqualify  about 5 percent of current blood donors in the United States.  Nonetheless,  given the overall growth in blood collections in recent years, it is likely that  suppliers and others involved in blood collections, on the whole, can  compensate for donor losses from the new policy.
subsections: section_title: New vCJD Donor Exclusions Are More Restrictive
paragraphs: In August 1999, FDA issued guidance that recommended prohibiting  donations from individuals who had resided or traveled in the United  Kingdom for a total of 6 months or more from 1980 through 1996, a period  during which that country experienced an epidemic of BSE in cattle.  In  response to the detection of BSE in cattle in European herds, in January  2002 FDA issued guidance to expand this recommended exclusion to  prohibit donations from individuals who had spent a cumulative 3 months  in the United Kingdom from 1980 through 1996, or 5 years or more in a  European country since 1980.   The portion of FDA’s new guidance  pertaining to residents of the United Kingdom and France took effect on  May 31, 2002, and the deferral of donors who have resided in other  European countries will take effect on October 31, 2002.  FDA’s guidance  exempts donors of source plasma who had resided in Europe for 5 years  from 1980 through 1996, but it prohibits source plasma donations from  those who had resided in the United Kingdom for at least 3 months from  1980 through 1996.  The guidance also recommends indefinite deferral of  source plasma donors who have spent 5 or more years cumulatively in  France from 1980 to present.
The Red Cross and DOD have independently adopted donor deferral  policies for their blood centers that are more stringent than FDA’s  guidance.  The Red Cross excludes donors who have spent a cumulative 3  months or more in the United Kingdom or 6 months in a European country  since 1980.  The Red Cross policy does not exempt plasma donors because  most of its plasma is recovered plasma from donors of whole blood.  DOD’s  policy made minor modifications to FDA’s new deferral criteria.  The new  deferral policies are described in greater detail in appendix I.
section_title: New vCJD Donor Exclusions Lower Potential Risk but Also Reduce the Number of Eligible Donors
paragraphs: Because so little is known about the etiology of vCJD, estimates of the  public health benefits from blood donor exclusions related to vCJD are  uncertain.  It has not been established that vCJD is transmissible through  blood, and no tests to diagnose vCJD or detect vCJD in blood have been  developed.  Nonetheless, laboratory experiments point to a theoretical risk  of transmission of vCJD through blood.  (See app. II for a description of  scientific research on vCJD.)
FDA estimates that the additional risk reduction from the new vCJD donor  deferral policies is substantially lower than the risk reduction derived from  its initial deferral guidance.  FDA estimates that its initial donor deferral  that took effect in April 2000 reduced the amount of theoretical risk of  vCJD transmission through blood transfusion in the United States by 68  percent and that the expanded deferral guidance is expected to reduce  total risk of donor exposure to the agent that causes vCJD by an additional  23 percent, for a total risk reduction of 91 percent.  Using the same  methodology, FDA estimates that the Red Cross’s new donor deferral  policy will decrease the total theoretical risk of exposure to the vCJD agent  by 92 percent (1 percent more than FDA’s donor deferral  recommendations).
Estimates of the percentage of current donors who would be disqualified  under the new deferral policies are substantially larger than the estimated  donor losses from the first vCJD donor deferrals.  On the basis of data from  a 1999 survey of blood donors, FDA estimates that its new deferral policy  will disqualify about 5 percent of current blood donors and that the Red  Cross deferral policy will disqualify about 9 percent.  On the basis of the  results of a June 2001 survey of its own blood donors, the Red Cross  estimated that its deferral policy would be less disruptive than FDA  expects, resulting in a loss of about 4 percent of active donors.
section_title: Nationwide Blood Supply Can Likely Compensate for Donor Losses Resulting from New Policies
paragraphs: The overall growth in the U.S. blood supply in recent years and the  demonstrated ability of particular blood suppliers to increase collections  indicate that the blood industry as a whole can compensate for donor  losses from the new vCJD donor deferrals.  First, as we noted earlier, the  long-term trends in blood collections are positive, and collections have  increased substantially over the last 5 years.  For example, prior to  September 11, NBDRC had estimated that the nation’s blood collections for  2001 would exceed the number of units transfused in 2000 by more than 7  percent.  Second, the Red Cross was able to increase its blood collections  in early 2001—collections were 2 percent higher in the first 7 months of  2001 compared with 2000—despite the April 2000 implementation of FDA’s  initial deferral guidance and Red Cross’s adoption of a new techinique to  measure red blood cell levels that disqualified 6 percent of potential donors  at its centers.  Red Cross reported collections in July 2001 that were 8  percent higher than for the same period in 2000.  Finally, before September  11, NYBC was able to increase its collections at a 12 percent annual rate  over the last few years.  We believe that this large and sustained increase in  collections for an individual blood bank that was previously known for a  chronic shortfall in collections indicates that blood centers will be able to  increase collections in response to the new vCJD donor policy.
Despite the adequacy of the nation’s blood supply, individual blood  collection centers with a relatively large proportion of donors who have  traveled to Europe will be more severely affected than others by the new  exclusion policies.  If these centers cannot find ways to increase local  blood collections, they, or the hospitals they serve, will need to purchase  blood from suppliers with an adequate inventory.  The Red Cross donor  survey found that its most affected regions would lose 5 percent of their  donors, compared with 2 percent for the regions least affected.  Blood  centers in coastal urban areas that have a greater number  of donors who  have traveled overseas could experience deferral rates greater than 5  percent.  Some other centers serving areas with many people who have  lived overseas, such as DOD-affiliated personnel, will also be  disproportionately affected.  NYBC will probably be affected the most  under FDA’s new deferral policy.  NYBC currently imports about 25 percent  of its supply from three European blood centers that collect blood under  NYBC’s FDA license.  NYBC will be unable to import blood from these  centers when the second phase of FDA’s new deferral policy takes effect on  October 31, 2002.  Prior to September 11, NYBC was confident that it could  compensate for the loss of supply from its European centers because it had  substantially increased domestic collections during the last few years.   However, NYBC now claims that its local donor base has decreased by  about 25 percent since September 11 because many of the companies that  participated in its blood drives were directly affected by the terrorist  attacks and have reduced employment levels in the city.  To compensate for  the loss of blood from its European centers, NYBC has contracted to  purchase blood from many other domestic blood suppliers, including the  Red Cross and blood banks affiliated with ABC.
section_title: Recent Blood Price Increases are Partly the Result of New Measures to Improve Blood Safety
paragraphs: Although blood is collected primarily from unpaid volunteers, blood banks  incur costs from collecting, processing, and testing donated blood.  To  recover these costs, blood banks sell the processed blood to hospitals.  The  prices paid by different hospitals and prices for different types of blood  vary substantially.  Furthermore, the average price of blood has risen  sharply since 1998.  One of several contributing factors to these price  increases has been the introduction of new blood safety measures.  For  example, leukoreduction adds about $30 to the price of a unit of blood.
Although not widespread in 1998, leukoreduction is performed on most  blood sold in the United States today.
Price of Blood Varies Widely To recover the costs of collecting, processing, and testing, blood banks sell  their processed blood.  Because hospitals and suppliers negotiate the price  and quantity of blood to be delivered, prices vary considerably depending  on the size and location of the hospital and the type of blood purchased.   Larger hospitals, and those in areas with more than one blood center, may  sometimes pay less than other hospitals.  For example, one of the hospitals  we contacted told us that its average price for a unit of blood was $135,  while another hospital told us that its average price was $200.  Similarly,  ABC told us that the list prices charged by its centers for a unit of  leukoreduced red blood cells in September 2001 averaged $143, but one- quarter of the centers charged $124 or less and one-quarter charged at least  $160.  In addition, prices for units of the most useful blood types can be  much higher than those for blood types that are in less demand.  For  example, in 2001, one independent blood center charged its non-sole- source customers more than $260 dollars for a unit of type O-negative  blood but less than $60 for a unit of AB-positive blood.
subsections: section_title: Price of Blood Has Increased Sharply in Recent Years
paragraphs: The average price of a unit of blood sold to U.S. hospitals has increased  substantially since 1998.  Both the Red Cross and ABC-affiliated blood  banks increased average prices by more than 50 percent from 1998 through  2001 (see table 1).  The Red Cross made additional price increases of 10 to  35 percent for different types of blood at the beginning of its fiscal year  2002 (which began July 1, 2001) that are not reflected in the table.
section_title: New Processing and Testing Steps Have Contributed to Price Increases
paragraphs: Blood suppliers gave us several reasons for the recent price increases.   They claimed that blood prices previously had been too low to support  their blood collection and processing infrastructure.  For example,  according to a Red Cross official, the Red Cross revenue from blood  services could not cover its costs associated with transporting blood,  training and retaining staff, and obtaining and using new technologies.  In  addition, the Red Cross told us that it increased prices in order to hire  additional staff needed to comply with the terms of its consent decree with  FDA.
New processing and testing steps that improve blood safety also have  contributed to the price increases.  The most substantial change is  leukoreduction, the removal of white blood cells from blood.  For example,  the average nationwide price of a unit of blood from the Red Cross in fiscal  year 2001 was $104 for nonleukoreduced blood and $136 for leukoreduced  blood.  The percentage of units that have been leukoreduced has risen  sharply in recent years.  The Red Cross reported that the percentage of its  blood that was leukoreduced went from zero in 1998 to almost 80 percent  in 2000 and to 95 percent at the beginning of 2002.  ABC estimates that by  December 2002 about 57 percent of the blood supplied by its affiliated  blood centers will be leukoreduced.  Similarly, a study commissioned by  AABB has estimated that NAT added about $8 to the price of a unit of blood  in 2000.  Most blood supplied in the United States now undergoes NAT.
section_title: Conclusions
paragraphs: The nation’s blood supply remains generally adequate, and collectively  America’s blood banks probably will be able to compensate for donors lost  as a result of the new vCJD donor deferral policies.  Lessons learned from  blood collection and usage after the September 11 terrorist attacks have  prompted efforts to improve how blood suppliers respond to public health  emergencies.  However, questions about the adequacy of the blood supply  will continue because the demand for blood is increasing and because new  testing procedures and donor deferral policies that arise in response to  emerging disease threats may continue to reduce the pool of potential  donors.  For these reasons, there is a clear need for comprehensive, long- term monitoring of the blood supply.
section_title: Agency Comments
paragraphs: We asked for comments on a draft of this report from HHS and DOD.  HHS  responded that it had no general comments.  DOD concurred with our  findings (see app. III).   Both HHS and DOD made additional technical  comments that we have incorporated where appropriate.
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Please contact me at (202) 512-7119 if you have any questions about this  report.  Another GAO contact and staff acknowledgments are listed in  appendix IV.
section_title: Summary of vCJD Donor Deferrals
paragraphs: FDA estimated 5%   91% in total  1996, of 3 months or more  Cumulative travel to Europe, 1980-present,  (23% from new  deferral criteria)
FDA recommends deferral of source plasma donors with 5 years cumulative travel in France from  1980 to the present. However, FDA’s new deferral policy for 5 years exposure elsewhere in Europe  does not apply to source plasma. In part, this reflects FDA’s belief that, on the basis of the results of  experiments conducted by plasma product manufacturers, the manufacturing process for plasma- derivative products minimizes the risk of transmission of vCJD through plasma.  In addition, FDA is  concerned that disqualifying plasma donors by extending the deferral policy to them may threaten the  sufficiency of the plasma supply.  The Plasma Protein Therapeutics Association (PPTA) conducted a  donor travel survey in 30 plasma collection centers and found that donor losses could range from 0 to  13 percent, with the greatest losses occurring at centers located near military bases.  The overall  donor loss was estimated to be about 3.5 percent.  A survey conducted by one of PPTA’s member  companies suggested that overall donor loss would be closer to 5 percent.  PPTA also expected that a  ban on the use of plasma in the United States from European donors, as would occur if the vCJD  deferral policy was applied to plasma, would adversely affect an already tight supply of plasma-derived  therapeutics, causing some countries to reject European plasma and thus putting extreme pressure on  other sources of plasma, such as the United States, to meet global demand.
section_title: Risk of vCJD Infection through Blood Transfusion Is Unknown
paragraphs: Transmission of vCJD by human blood or plasma has not been  demonstrated, and no laboratory or epidemiological studies have shown  that blood from donors infected with vCJD carries the disease.  For  example, at least 20 people in the United Kingdom have received blood or  blood components from donors who later developed vCJD.  Although  relatively little time has passed, none of the recipients of the blood have  developed vCJD.  Studies of patients with vCJD and a prior history of  receiving blood transfusions have not revealed any cases of vCJD among  the donors involved.
Nonetheless, laboratory experiments point to a theoretical risk of  transmission of vCJD through blood.  For example, tissue samples from  vCJD patients have found the agents that cause vCJD, protein molecules  known as prions, in human lymph tissue, such as the tonsils and the spleen.   Since white blood cells known as B lymphocytes also circulate through  these tissues and are potentially involved in the pathology of vCJD,  researchers suggest that these circulating lymphocytes may carry  infectivity in blood.  Experiments with animals have shown that blood  infected with vCJD-like agents contain low-levels of infectivity.  In addition,  one group of researchers has recently demonstrated that BSE can be  experimentally transmitted between sheep by blood transfusion.   However, results from this experiment may not be representative of the  human manifestation of vCJD.
Epidemiological Predictions  Researchers are limited in the conclusions they can make concerning vCJD  and blood safety, and in predicting the future number of vCJD cases.  Important variables in determining the probability of BSE transmission to  humans, such as route of exposure, genetic susceptibility, and dose, remain  unproven.  Further, the incubation period for vCJD is unknown but is  probably many years.  Citing the current modest number of additional  deaths in the United Kingdom caused by vCJD (there were 28 confirmed or  probable vCJD deaths in the United Kingdom in 2000 and 20 in 2001), some  researchers suggest that the epidemic will not reach the hundreds of  thousands once thought possible.  As a result, the projected number of total  cases has been revised downward to just a few hundred or few thousand  cases, with fewer than 100 new cases occurring per year. Such revised  estimates are based on varying assumptions regarding the average  incubation period and when individuals were infected.
The ambiguity of the scientific evidence regarding vCJD transmission  through blood is reflected in the divided vote of FDA’s advisory committee  (the Transmissible Spongiform Encephalopathies Advisory Committee, or  TSEAC) in favor of the expanded donor deferral.  The committee voted 10  to 7 in June 2001 to move forward with the proposed changes, but several  members expressed concern about the expanded deferral’s impact on  blood availability, the effectiveness of current efforts to control human  exposure to BSE in the United Kingdom, and the reliability of European  surveillance data.
subsections: section_title: Detection Tests for vCJD under Development
paragraphs: The scientific uncertainties surrounding vCJD would be greatly reduced if a  diagnostic test existed to confirm the presence or absence of vCJD in  human blood.  While tests are being developed, it could be some time  before an accurate test will be available to screen blood for the vCJD agent.   Tests do exist to detect vCJD prions in some human tissues, such as brain  tissue, tonsils, and appendixes, but no suitable tests are available to detect  vCJD infections in blood.  Prions are different than viral and bacterial  pathogens, which contain nucleic acids.  Some pathogens and viruses  trigger the human body to release specific antibodies, which may be  detected in the blood.  For example, both HIV and hepatitis elicit antibodies  in the blood that can be detected in a blood test.  At this point, most  scientists believe that prions, such as those involved in vCJD, do not  contain nucleic acids and do not elicit the production of antibodies.  This  poses a challenge in designing a blood test, which must be 100,000 times as  sensitive as assays that already exist for detecting prions in tissues.  If a  test were approved, it would be required to be extremely sensitive to  minimize the possibility of false positives, which would unnecessarily defer  from donating blood many individuals who did not actually have the vCJD  agent in their blood.
section_title: Comments from the Department of Defense
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: The following staff made important contributions to this work:  Carolina  Morgan, Sharif Idris, Mark Patterson, and Elizabeth Morrison.
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