Bad Blood
Rollin Tobin had heard about contaminated blood, and now he faced hip replacement surgery. The worried 59-year-old public safety director for Southfield, Mich.--"Jerry" to everyone who knew him--arranged to donate his own blood in advance to protect himself. According to court documents, Tobin even had three units drawn--about 3 pints--though he was told two would be enough. But during the operation last November 12 at Southfield's Providence Hospital, a fourth unit was requisitioned from the hospital's inventory. After surgery, Tobin's blood pressure started dropping; two hours later he was back for exploratory surgery. He died at 7:30 the next morning of massive clotting caused by Yersinia, a toxic bacterium in the fourth unit. "What he most feared what he tried to prevent--is what happened," says attorney George Googasian, who is representing Tobin's widow in a suit against the hospital (which refused to comment on the case). The donor of the contaminated unit was infected, says the American Red Cross, whose Madison, Wis., center supplied the blood. There is no practical screening test for Yersinia.
Blood experts and public health officials contend the blood supply is safer than it has ever been. That is accurate. But patients like Jerry Tobin are a reminder that "safer" is not safe enough. And a five-month U.S. News investigation involving more than 150 interviews, 16 Freedom of Information Act requests and nine government databases shows that transfusions are far riskier than patients are led to believe. Toxic bacteria, though alarming, are not the biggest hazards. About 4,200 units of blood infected with viruses that cause hepatitis slip through undetected every year. Food and Drug Administration Commissioner David Kessler has told Congress that between 90 and 460 units harboring HIV get through. And the chance of an allergic reaction to a transfusion is as high as 1 in 25.
Clerical errors and other mistakes further expose patients to contaminated, mistested or mislabeled blood. Many patients who get bad blood aren't told. And "recalls," typically taking place months or years after the fact, don't work. Highlights of the U.S. News investigation:
Blood banks know that more than 100,000 individuals may have received blood harboring the virus that causes hepatitis C--which can lead to chronic liver disease--but have not alerted them.
By March 1994, almost a year after the FDA sued the American Red Cross to improve safety at its blood centers, critical problems were still unresolved.
Many hospital patients are not informed of transfusion risks. And only about 1 hospital in 8 obtains specific patient consent for transfusions.
Official reports may drastically understate blood problems. One reason: Most of the nation's 2,400 blood banks do not ship interstate and thus are not required to be federally licensed--or to report mistakes to the Food and Drug Administration. Those banks appear to commit a large proportion of the serious errors.
Americans have long believed the blood supply to be safer than it is. In a 1983 joint statement, for example, the Red Cross and two trade groups representing most other blood banks--the American Association of Blood Banks and the Council of Community Blood Centers--put the risk of getting AIDS from a transfusion at about 1 in a million. In fact, it was at least 1 in 660--and up to 1 in 25 in high-exposure cities like San Francisco. The chance of infection by the virus that causes hepatitis C--then known as non-A, non-B hepatitis--ran as high as 1 in 6, according to a 1985 report by Congress's Office of Technology Assessment.
A decade later, improved tests have reduced the risk of getting HIV from an average four-unit transfusion to between 1 in 11,000 and 1 in 59,000; the risk for hepatitis C is now about 1 in 900. And just last week, scientists announced a discovery that may reduce the need for transfusions. Researchers isolated thrombopoietin--a protein crucial to the formation of platelets, which in turn are fundamental to clotting. Researchers at Genentech Inc. in San Francisco and Zymogenetics Inc. of Seattle reported in the journal Nature that the protein must now undergo clinical trials. Cancer patients may be the first to benefit, since therapy often destroys platelets, requiring transfusions from many donors.
Blood banks get virtually all of their blood from volunteers--although plasma centers, which save just the plasma from donors and reinject the red cells, still pay donors $10 to $15 per visit. The plasma--the amber, liquid portion of blood--is usually used to make drugs like immune globulin that are heated or otherwise treated to kill viruses.
Despite safety advances, slip-ups still occur. They are committed by doctors, nurses and blood bank technicians coping with increasingly sophisticated tests and by volunteers who screen donors. And one bad unit can create several victims, since whole blood is routinely split into components such as red cells, plasma and platelets. Since 1989, reported mistakes have soared. The FDA logged about 1,000 blood bank errors and accidents in the year ended Sept. 30, 1989. Three years later the number had shot up to 10,456, and the year after that the total was nearly 9,000. There has been no improvement since. Through March 1994, halfway through the current reporting year, the mistake toll stood at 4,615. Since the beginning of 1990, 29,586 mishaps have been reported.
Urgent plea. One factor behind the increase may have been a March 1991 letter from the FDA scolding blood banks for being lax in reporting errors and accidents. But public health officials attribute the jump more directly to the failure of some blood banks to safeguard the blood supply. In an internal memo sent last September to Health and Human Services Secretary Donna Shalala, Philip Lee, head of the Public Health Service, called the surge in errors "increasing evidence" of safety problems. At least a fourth of all major blood banks, he said--and up to a third of those run by the Red Cross--violate federal safety standards. "These compliance problems ... need to be addressed urgently if FDA is to ensure the safety of the nation's blood supply," he wrote.
The most worrisome offender may be the American Red Cross. Numerous safety slip-ups in the 1980s led to a 1988 "voluntary agreement" with the FDA. Yet by 1991, the FDA had threatened to close Red Cross centers in Albany, N.Y., Charleston, S.C., and Portland, Ore., for transgressions from botched tests to bags of blood labeled with the wrong blood type. Between 1988 and 1993, the FDA documented more than 2,500 safety violations at Red Cross blood banks. Finally, in May of 1993, the FDA brokered a consent decree in U.S. District Court in Washington, D.C., to raise the Red Cross's standards according to a timetable.
"Are we in compliance with the consent decree? Yes," Karen Shoos Lipton, acting head of Red Cross blood services, told U.S. News. But in March, FDA inspectors uncovered more than two dozen systemic problems after a nine-week inspection at the group's Washington, D.C., headquarters--the first such review since the consent decree. Many were similar to those that first prompted the FDA to act. For example, the Red Cross had not acceptably standardized investigations into possible cases of disease-borne transfusions, as the consent decree required. Nor had a written plan been developed to evaluate the training of blood workers.
FDA visits to some of the organization's 45 regional operations turned up other troubles. Last year, for instance, the Miami branch lost track of 4,775 units of blood, at least 197 of which had tested positive for hepatitis and other viruses. The Red Cross says positive units were never labeled and could not have been shipped. An inspection last fall of the Boise, Idaho, regional center, a source of significant snafus since 1990, documented transgressions so serious that the FDA threatened to shut down the facility. In a Feb. 23, 1994, letter, the FDA said the Red Cross "has failed to fully comply with the consent decree ... and violated the law." The center has been closed to retrain the staff.
Given its findings, the FDA could ask the federal court to fine the Red Cross. The agency could even force the Red Cross out of the blood business, although sources familiar with the FDA believe that is unlikely. (FDA chief Kessler declined to be interviewed for this story.) Yet insiders say an unwieldy bureaucracy and a social-service mentality are suited to disaster relief but not to regulated, high-tech blood banking. "It's impossible for the Red Cross to do what the FDA wants," says a former Red Cross executive. "It just doesn't have the structure in place." He predicts the regional centers will be spun off as independent blood banks or sold.
Karen Lipton states that the Red Cross will not get out of blood banking. The group did seriously consider bailing out when faced with the terms of the 1993 consent decree, she says, but elected instead to go through with a $147 million "transformation," first announced in 1991, to turn things around. The organization has made many improvements of late, she says; it has consolidated 28 unlinked computer systems into 10, for instance, and has centralized testing for its 45 regions in six primary labs. Yet even Lipton calls the Red Cross's blood division "an organization in time of crisis." And in an April 7 letter to the group's board, Red Cross President Elizabeth Dole said that "problems remain," and outlined plans to reorganize the blood division. She could not be reached for comment on this story.
Exception. Nonetheless, the Red Cross and other industry groups stress the safety of the blood supply. "In the last seven years, only one error that seriously harmed a patient has been found in the production of over 140 million volunteer donor components," declared William Coenen, president of the Council of Community Blood Centers, at an Institute of Medicine forum in May. That error occurred in 1987 at the New York Blood Center, where a technician failed to notice a positive HIV test result for one unit of blood. The blood was split up and sent to three patients; one later died of unrelated causes, one has disappeared and one developed AIDS. The mistake wasn't discovered until 1993.
It was no one-time incident. Even when patients get "hot" (contaminated) blood, the CCBC does not officially count them all--it may not be aware of the cases or the FDA didn't blame the bank, says Jim MacPherson, the group's executive director. Among other cases unearthed by U.S. News:
February 1994. At Memorial Sloan- Kettering Cancer Center in New York City, 16 units of blood tainted with cytomegalovirus--a generally harmless bug that can be dangerous to cancer patients--were labeled negative for CMV. Five units were given to four different patients. The hospital says none has shown signs of CMV infection.
December 1991. At Puget Sound Blood Center in Seattle, a test failed to pick up hepatitis C virus in a blood sample. By the time a later test found the virus, an infected unit of platelets--blood components that aid clotting--had been transfused. The blood bank would not release information on the patient.
September 1991. A technician at United Blood Services in Chicago mistested a unit of blood that carried the hepatitis C virus. One patient got a transfusion; the blood bank would not comment further.
October 1990. A technician at New York Methodist Hospital in Brooklyn dispensed a unit of hepatitis-C-infected plasma that did not appear in a computer log of available units. The plasma was transfused, and the patient was later diagnosed with hepatitis C.
November 1988. At Beth Israel Medical Center in New York City, a unit of HIV contaminated blood that tested positive was marked negative and transfused. The patient got HIV.
Many months can pass before such errors emerge. FDA records from 1989 on indicate an average of more than 300 days from the date a blood bank commits an error to the date it is reported to the FDA. Some errors take years. Auditors digging through Los Angeles Red Cross records last summer discovered four HIV positive units of plasma distributed between 1985 and 1987. The Red Cross says two units went to make blood-testing substances that would never be given to a patient. The other two went into products like immune globulin.
Most blood banks do not even have to report mistakes to the FDA. Of the 2,400 U.S. banks, only the quarter or so that are licensed to ship blood between states are required to do so. The FDA asks the others, most of them hospital blood banks, to report voluntarily; some states, including California, New Jersey and New York, regulate them as well.
Non-FDA-regulated blood banks account for just one tenth of the blood collected in the United States but may be responsible for most of the errors that jeopardize patients. In New York State, where all blood banks must report errors to the state Department of Health, 27 patients since 1990 have received blood that flunked screening tests for diseases like hepatitis and syphilis. In every incident, the source was a blood bank not licensed by the FDA--and none of the cases has been listed as an FDA "recall," the designation for a release of suspect blood.
Flawed yardstick? Yet recalls are used by the CCBC and other industry groups as a marker of safety. If New York is at all typical--there's no reason to think that it is not--federal statistics could represent a dramatic undercount. "The role of errors is not sufficiently considered in assessing the safety of the blood supply," says Jeanne Linden, director of blood and tissue resources for New York State's Health Department.
Recalls make little difference anyway. Unlike recalled cars or baby strollers, recalled blood is usually irretrievable; about 90 percent of it has already been transfused. Last October, for example, the Metropolitan Washington Blood Banks in Silver Spring, Md., recalled 161 units of blood improperly screened between 1984 and 1992. None of the 161 units was retrieved. FDA officials defend recalls as a way to pull back the small amount of blood still on the shelf, saying hospitals need to be notified of potential problems. Yet in two thirds of all recalls since 1985, blood centers didn't even verify whether hospitals got the message.
FDA records show that more than 370,000 units of blood and plasma have been recalled since Oct. 1, 1989. Most recalls involve fewer than 10 units of blood, but some number in the thousands--or more. A single 1991 recall by Sera-Tec Biologicals, a plasma collector based in North Brunswick, N.J., accounted for nearly 300,000 units that were improperly tested for HIV. No patients were harmed, the manufacturer concluded after a follow-up. In addition to blood, at least 1.2 million defective test kits or components used to screen for viruses and identify blood types have been recalled since 1990, as have 660 or more defective software programs used to track blood through safety checkpoints.
Even when blood banks are diligent, contaminated blood can leak through. With HIV, for instance, tests detect the antibodies produced by the body in response to HIV, not the virus itself. There is a window of about six weeks during which infected donors may not have formed antibodies to the virus--and would not test positive for HIV.
To close the window, donors who may have been exposed to HIV or other transmissible illnesses are supposed to be rooted out with questionnaires about their behavior. Yet about 1,000 people with HIV and 46,000 with hepatitis manage to give blood every year. Many of them apparently do not understand until too late that their blood could be dangerous. Of the roughly 30,000 mistakes blood banks have reported to the FDA since 1990, more than 10,800 are traceable to donors who informed blood banks after leaving the donor center that their blood might be unsafe. Most reported flulike symptoms or other minor illnesses. But in 825 cases, donors belatedly admitted using intravenous drugs; in 336 other reports, men said they had had sex with another man.
Statistically, the risk of infected blood is still tiny for each of the 4 million patients who get blood transfusions every year. But that is no comfort to the exceptions. Christine Smith, for example, was astonished to learn after recuperating from hip surgery last May that she had contracted HIV during the operation. The 70-year-old Denver widow received infected red blood cells from Denver's Belle Bonfils Memorial Blood Center even though the blood had been screened. "I didn't even think about bad blood," she says. Smith carries Clorox and Band-Aids with her wherever she goes and frets about inadvertently passing the virus to one of her five grandchildren or two great-grandchildren. "I run for cover every time I skin my arm," she says. The lethal unit infected two other patients. Linda Fitzgerald, a 69-year-old widow from Longmont, Colo., got HIV during gallstone surgery last May when she was given plasma from the contaminated unit. Lyman Southwell, 70, of Aurora, Colo., was infected by platelets from the same donation during surgery for an aneurysm last April. He died last October of causes unrelated to AIDS.
Juggling numbers. The federal Centers for Disease Control and Prevention says that only 29 people are known to have developed AIDS from blood transfusions since testing started in 1985--a figure echoed publicly by the Red Cross and other blood banks. Yet the CDC counts only transfusions in which HIV has led to full-blown AIDS, thus excluding the Denver trio and others who have gotten HIV from a transfusion but do not yet have AIDS. If the estimate by FDA chief Kessler of 90 to 460 HIV-positive donations annually is accurate, somewhere between 810 and 4,140 people have actually received HIV-contaminated blood since 1985.
Perhaps more important than precise numbers is honesty with patients about the risk. "Blood transfusion is the most promiscuous thing that human beings do" is how Theodore Koerner, associate medical director of Iowa City's DeGowin Blood Center, put it in a deposition for a lawsuit last summer. "It's even more promiscuous than having sex with people we haven't selected well."
Yet many patients are unaware of the risks. A 1991 survey by the American Association of Blood Banks of 2,150 hospital blood banks and regional blood centers (where some transfusions are performed) found that only 1 in 8 had a policy of presenting patients with informed-consent material specific to transfusions. Another study, of 81 hospitals by researchers at Temple University, in Philadelphia, found patients somewhat better informed, with 50 hospitals obtaining written consent. But of 48 forms employed, 11 did not mention any complications. Hepatitis appeared on 22 forms and HIV on only 12. Alternatives to banked blood, such as self-donation and other so-called autologous options, were cited on 10 of the 48 consent forms (box, Page 78).
No alert. Patients who receive HIV-tainted blood usually are informed as soon as the discovery is made. That is not the case with hepatitis C. Many problems come to light when repeat donors test positive for HIV or hepatitis; the blood bank can then check its records for earlier donations from the same people. Those donations could have been infectious and still passed screening because of the absence of antibodies. Most blood banks do such a "look-back" when HIV is involved and notify the doctor or hospital, which then informs the patient.
However, with hepatitis C--which causes chronic problems in half the people it infects and is occasionally fatal--such look-backs might be termed "look-aways." Virtually no blood banks try to find recipients of blood that may have carried hepatitis C, even though their names are on file. Experts believe that more than 100,000 transfusion recipients may be carrying the hepatitis C virus--most of them unknowingly.
Lawsuits are largely to blame. "Blood centers have an inherent fear of being sued," says Ronald Gilcher, president of the Oklahoma Blood Institute, a blood bank in Oklahoma City. He and others estimate that about half the lawsuits against blood banks and hospitals involving transfusion-related HIV infections have followed look-back notifications. Since hepatitis C look-backs would outnumber HIV look-backs at least 40 to 1, the legal burden could be far heavier.
A few blood banks have attempted look-back programs since 1990, when the test for the hepatitis C virus was approved, but have met resistance from doctors, hospitals and other blood banks. In Dallas, for example, at least two hospitals--Baylor University Medical Center and Presbyterian Healthcare System--failed to act on 1990 look-back notices from Dallas's Blood Center at Wadley (since renamed BloodCare), according to documents in a pending lawsuit against the hospitals. (Baylor would not comment; Presbyterian cites government and industry guidelines against look-backs.) The Blood Center of Southeast Louisiana in New Orleans got good cooperation from hospitals when it started doing hepatitis C look-backs in the fall of 1990, says Dave Smith, the center's medical director at the time. But several blood banks that had purchased blood from the New Orleans center for local use simply returned look-back notifications, refusing to try to track down the recipients. Both the Dallas and the New Orleans centers have since abandoned their look-back programs. Tom Carson, current medical director at Southeast Louisiana, says one reason was that the number of look-backs was greater than anticipated.
The federal government itself opposes hepatitis C look-backs. In 1991, the Centers for Disease Control and Prevention advised against the practice because the cost would be high relative to the benefits. Patients with hepatitis C, for one thing, are less likely to pass the virus to someone else through sex than are those with HIV. And treatment is still considered uncertain.
But some doctors now feel that chronic hepatitis C infection is a silent epidemic. Taken together, two studies in the Dec. 31, 1992, New England Journal of Medicine suggest that the virus can lurk undetected for up to two decades but still cause death from cirrhosis and liver cancer. And studies now show that treatment for up to 18 months with interferon alpha and other antiviral agents can cure the underlying infection in 60 percent of patients, although complications, including blood vessel inflammation and fatigue, often persist.
"If we don't do a look-back, we're essentially concealing information from the patients.... I can't imagine that we can avoid this kind of responsibility," stated Malcolm Schoen, an internist and member of the FDA's blood products advisory committee, at a meeting held last December to discuss the issue.
Is testing better? Many in the blood industry argued strongly against mandatory look-backs. Paul Holland of the American Association of Blood Banks asserted that many blood recipients do not want to know they may have the virus. He cited one study of 206 possible look-back cases in which only 19 percent of patients who received contaminated blood and were notified through a look-back agreed to be tested for the virus. (Of the remaining patients, however, only 17 percent actually declined to participate. Most of the rest either had died or couldn't be found.) Both the AABB and the CCBC say that a more efficient way to notify recipients of bad blood would be to test all blood recipients for viruses six months after they have been transfused.
The committee voted 5 to 4 nevertheless to recommend hepatitis C look-backs. Because of the close vote and the opposition from the blood industry, the FDA says it will have to hold more meetings before it announces an opinion.
Look-backs are not the only concern the FDA has put on hold. FDA records reveal 28 instances since September 1990 in which FDA district officials urged the agency to move against error-prone blood establishments--and apparently nothing happened. Seventeen of the recommendations called for warning letters to castigate firms for serious violations; five urged license revocations; three asked for a license suspension, a product seizure or a prosecution.
Problems that emerge when the FDA does act may be more disquieting. On June 8, for example, the agency announced that it had suspended the license of a United Blood Services center in Lubbock, Texas--primarily because of evidence that documents had been falsified. Blood workers also failed to ask donors questions meant to catch those at high risk for HIV. UBS says it is investigating the charges.
Sometimes avoiding bad blood is a matter of luck. Stanford University Hospital, for example, bought a rare type of plasma earlier this year from an out-of-state blood center. The donor later tested positive for HIV--which meant the plasma Stanford purchased was likely infected. The blood center, however, didn't notify Stanford until at least two weeks after tests first indicated the donor was infected, says Edgar Engleman, medical director of Stanford's blood bank. (He won't identify the center.) The delay could have been fatal. But the patient for whom the plasma had been ordered had recovered and had not needed those units. For that person, the blood supply turned out to be safe--by chance. Related material on U.S. News Online on CompuServe. Free start-up kit: (800) 510-4247. THE METHODOLOGY: U.S. NEWS REPORTERS USED THE FREEDOM OF INFORMATION ACT TO OBTAIN NINE GOVERNMENT DATABASES RELATED TO BLOOD SAFETY. U.S. NEWS ALSO CREATED FOUR DATABASES. ONE MERGED 1,007 FOOD AND DRUG ADMINISTRATION RECORDS ON RECALLS WITH DATA HAND EXTRACTED FROM 2,978 PAGES OF FDA REPORTS. TWO DATABASES DREW ON MORE THAN 10,500 VISUALLY SCANNED MICROFICHE DOCUMENTS DESCRIBING FDA ENFORCEMENT ACTIONS. A FOURTH DATABASE WAS BASED ON A SURVEY OF 15 BLOOD BANKS. MORE THAN 150 SOURCES WERE INTERVIEWED DURING FIVE MONTHS OF REPORTING. The bloodline The path traveled by a unit of blood from donor to patient is full of potholes. Here's how blood gets where it's going, and what can go wrong.
1. Donors are recruited. Fewer than 5 percent of healthy Americans give blood; 80 percent of the supply comes from repeat donors. Most donors are recruited through blood drives or promotional and telemarketing campaigns.
Problem: The other 20 percent of needed blood comes from first-time donors, who are more likely to carry infectious viruses.
2. Donors are screened. About 190 regional blood centers collect most blood. Donors are screened through questionnaires meant to determine a higher-than average risk for HIV and infectious diseases like hepatitis. Names are also checked against lists of donors who previously gave unacceptable blood.
Problem: Of the 30,000 problems blood banks have reported to the government since 1990, more than half occurred in screening or in checking donor records. About 1,000 people with HIV and 46,000 with hepatitis donate infected blood each year.
3. The blood is tested. The Food and Drug Administration requires blood banks to check for HIV, syphilis and hepatitis B. Most do five other tests as well: for hepatitis C; HTLV-1, which can cause leukemia; HIV-2 (a strain that's rare in the United States) and two other potential indicators of hepatitis.
Problem: Glitches in testing--such as performing tests incorrectly or misinterpreting results--account for just 3 percent of all mistakes reported but are the most serious since they can lead to the release of contaminated blood.
4. The blood is separated. Most donated whole blood is separated into red blood cells, plasma, platelets and other "products," each with specific uses red cells to raise a patient's level of blood oxygen and platelets and plasma to promote clotting, for instance.
Problem: Since these separate products are usually transfused into different patients, one infected donor can infect two or three patients.
5. The blood is distributed. Most blood products are destined for transfusions in local hospitals. Blood banks that collect more blood than needed locally often sell the surplus to other blood banks.
Problem: Some usable blood never makes it off the shelf. A recent survey of 2,154 blood banks showed that in 1991 more than 1.2 million blood units had passed their expiration date and had to be thrown away. And 8 percent of mishaps involve blood that's lost, spilled, sent to the wrong place or otherwise improperly shipped.
6. Transfusion. There are some 4 million transfusions a year, each averaging about four units of blood.
Problem: Transfusion mix-ups in hospitals may occur 20 times more often than reported. Blunders include patients receiving blood that is not meant for them including other patients' self-donated "autologous" blood.
7. The bill. blood banks charge hospitals from less than $30 per unit to $120 or more, depending on the blood product and local medical costs. Patients typically pay hospitals double or triple the blood bank charge.
Problem: Already under pricing pressure, blood banks are reluctant to institute new safety procedures. Many hospitals are also curbing patient self donation programs because of the expense. Don't be afraid to donate Whatever the risks from transfusion, blood donors have little to fear. Sterile equipment is used to draw blood. Bad reactions are uncommon. And healthy repeat donors perform a public service by making the blood supply safer. They are less likely than are first-timers to carry blood-borne viruses.
BLANCHE SCHWARZER, 67 VANCOUVER, WASH. TRANSFUSED DECEMBER 1990. SUFFERING FROM PROGRESSIVE LIVER DISEASE. Before having surgery to repair a weakened abdominal vessel, Blanche Schwarzer donated three units of her own blood and lined up family and friends willing to donate if necessary. She thought she was safe. Yet she still received a unit of red cells from the Red Cross blood center in Portland, Ore. Symptoms of hepatitis appeared. She contends in a lawsuit--which is being challenged-- that the blood was infected with the virus that causes hepatitis C. (The Red Cross claims the donor tested normal.) Schwarzer has suffered progressive liver problems and has recently been hospitalized.
LINDA FITZGERALD, 69 LONGMONT, COLO. TRANSFUSED MAY 1993. NOW INFECTED WITH HIV. Four months after gallstone surgery in May 1993, Linda Fitzgerald learned she had contracted HIV from infected plasma received just before an operation to reverse the effects of blood thinners she takes for a heart condition. She has since begun suffering from swollen glands and other symptoms caused by the virus. The former waitress and store clerk finds it hard not to dwell on what will become of her. "When I think about what's going to happen..." She doesn't finish the sentence. "I just want to be on my own and wait on myself. I don't want to drag people down with me." ROBERT DUANE JONES, 62 WILSALL, MONT. TRANSFUSED NOVEMBER 1989. NOW DIAGNOSED WITH AIDS. Rushed into surgery with a burst abdominal artery, Bob Jones needed blood to pull through. Four months later, the Red Cross blood bank in Portland, Ore., called: One unit had come from a donor who had since tested positive for HIV. Later that week, Jones tested positive, too. In his lawsuit against the Red Cross, Jones contended the donor had not been asked specific questions meant to screen out people at high risk for HIV. The Red Cross and Jones settled the first day of the trial, the Red Cross admitting no wrongdoing. Jones has been diagnosed with AIDS and is now recovering from a lung ailment. Recall repeaters From Oct. 1, 1989, to March 30, 1994, these blood centers racked up at least 10 recall notices from the Food and Drug Administration because blood was released that failed one or more safety standards. In many cases the recalls were made public months or years after the blood was transfused.
Units of blood Blood bank (city) Recalls recalled Red Cross (Baltimore) 19 149 BloodCare (Dallas) 15 3,928 Red Cross (St. Paul, Minn.) 15 95 Red Cross (Charlotte, N.C.) 14 214 Central Indiana Regional Blood Center (Indianapolis) 13 60 Red Cross (Portland, Ore.) 12 124 Red Cross (Peoria, Ill.) 11 62 LifeSource Blood Services (Glenview, Ill.) 11 343 Red Cross (Dedham, Mass.) 11 91 Belle Bonfils Memorial Blood Center (Denver) 10 15,955 Red Cross (St. Louis) 10 20 Behind the error reports From Jan. 1, 1990, to April 7, 1994, the Fodd and Drug Administraton received 29,586 reports from blood banks of "errors and accidents" in testing, handling and distributing donated blood. Here is a sampling of problems and the number of reported for each: Storage and shipping 2,506 Inadequate testing for blood type 2,025 Inadequate testing for hepatitis 621 Incorrect product released, such as plasma
instead of platelets or wrong blood type 621 Donor called back to report hepatitis-related
illness 581 Donor later reported history of exchanging
sex for drugs or money 433 Donor later reported having had sex with an
IV drug user 433 Donor later reported having had sex with a man
who had had sex with another man 322 Inadequate test for HIV 151 Inadequate test for syphilis 112 Donor later reported that a sexual partner had
tested HIV positive 109 Blood accepted from donor with high riskof AIDS 50 Blood accepted from donor with high riskof hepatitis 36 A worrisome blood count Reports of blood and plasma center errors and accidents, many of which lead to blood recalls, have surged in the 1990s. One recall can encompass a single unit of blood--or many thousands. The 4,615 errors and accidents reported through March 1994 are a slight increase over the 1993 rate. [Information for the three charts is not available.] Note: Years are October 1 to September 30 and indicate when problems were reported, not when they occurred. A unit is usually about 1 pint of whole blood or the red blood cells, plasma or other products derived from that quantity of whole blood. USN&WR--Basic data: Food and Drug Administration via Freedom of Information Act
This story appears in the June 27, 1994 print edition of U.S. News & World Report.