Negligence human error and failed oversight

In the United States and other developed nations, errors in blood component preparation and testing are nowadays very rare - primarily due to bar-coding of all donor registration forms, blood donations, components, and sample tubes, as well as to large-scale automation of viral testing and testing for blood type, with computerized assimilation of all these test results to each pertinent blood donation. One type of error that can still occur is at the blood collection site, in the labeling of the form, the donation and/or the tubes of collected blood. Below are two examples of how human errors such as this might occur.

1. While each blood donor is handled separately from the others, a staff person evaluating the donor's history can turn the donor and the form over to another staff person, and then to the venipuncture technician to collect the blood and the tubes for testing. As a check, a second staff person is tasked to ask the donor to provide his name again so it can be checked with the paperwork before collecting the unit. If this check is not performed correctly, one donor's identifying information can become associated with another donor's unit of blood. While the donated unit will have all of the test results associated with it, if the donor subsequently calls back (this is an infrequent event) saying that he has developed a fever or has just learned of recent prior exposure to hepatitis, the wrong unit of blood will be recalled, and the one that should be recalled could be transfused.

2. A more ominous error would be a mix-up between the "whole blood number," with its associated bar code of one unit of blood, with the numbering on the tubes for testing from another donation. The bar code and number are manually placed on each of three or four tubes for testing, and on the unit of blood itself. If a staff person is interrupted during the placing of these bar codes on tubes and bags, or if the wrong tubes are picked up for filling just before or after collection of the unit of blood, then the test results will be associated with the wrong unit for transfusion. If one donor's test results are positive, the unit could still be labeled as acceptable due to clear test results from the other donor, and transfused. Since 80 percent of blood donations are from repeat donors and the blood type on prior donations is checked before labeling the current donation, the blood center most probably will know an error has occurred, will investigate, and will prevent the labeling and release of all potentially affected units if the blood types on the two donors are different (e.g. one is A positive and another is O negative). Finding such a discrepancy is a very rare event, due to the emphasis on training collection staff about the importance of donor identity and proper handling of blood samples and unit labeling. In addition, hospitals are required to re-check the ABO and Rh type of each unit of labeled blood they receive from a blood center before issuing it for transfusion to a patient. The consequence of adhering to strict procedures is that finding such a discrepancy at the hospital is a very, very rare event. Nevertheless, the practice of continuing this last check at the hospitals continues. If a test tube or unit does not have a proper number with bar code on it, it is not tested and not used, and the donation is discarded.

A number of high-profile scandals have occurred in blood-banking in developed nations, most notably during the first years of the AIDS epidemic, but also related to hepatitis C. One occurred in Canada, where in 1984 the Canadian Red Cross Society was importing plasma donations from the United States. At the time it was widely known that the AIDS epidemic in the United States had been associated with blood transfusion, especially among people with hemophilia. Meanwhile, Canada was not fully self-sufficient in its supply of blood products and, in particular, did not have adequate supplies of Factor VIII concentrate (the plasma derivative) for people with hemophilia. The Canadian Red Cross was faced with the difficult problem of weighing the risk of importing potentially tainted blood products against that of putting hemophiliacs at risk because of insufficient supplies of clotting agent. The Canadian Red Cross chose to continue importing US supplies. However, while the US Centers of Disease Control had in 1984 approved a test for HIV in blood, the Canadian Red Cross did not implement testing until late 1985.

A national scandal erupted when critics accused the government and the Canadian Red Cross of denial and negligence. In 1988, the Canadian Hemophilia Society requested compensation for victims. They were ignored. The victims persisted. In 1993, the Federal Government appointed a Commission of Inquiry, headed by Justice Horace Krever, to investigate the spread of HIV and hepatitis C through the blood-banking system. They concluded that Red Cross and Government oversight had led to failure to act in a timely manner to prevent the spread of HIV and hepatitis through the blood supply, that the system had been under-funded, and that Canada lacked a strong national blood policy with clear lines of responsibility across organizations and agencies involved in the entire process of blood-banking. Victims and families were awarded compensation. The Commission also concluded that donated blood is a national public resource, and safety is paramount. A national independent board was established, national standards were promulgated, and in 1998 the Red Cross was replaced by the new Canadian Blood Services to manage the blood-banking system. In 2004, federal, provincial, and territorial governments announced the country's first national standards to govern the handling of blood and blood products from "vein-to-vein." In May 2005, the Canadian Red Cross apologized and pleaded guilty to distributing tainted blood products. Dr Roger Perrault, the National Medical Director of the Canadian Red Cross at the time of the scandal, three other physicians, and Armour Pharmaceuticals (located in the United States) were put on trial for criminal negligence. That proceeding continues. It is estimated that perhaps 20,000 people were infected with hepatitis C, and about 1000 with HIV

As in Canada, epidemics of contaminated Factor VIII concentrate products for hemophiliacs also occurred in France and Japan during the 1980s. Scandals also erupted when it was recognized that high-level government officials either knew or should have known that the products were unsafe, and were culpable for permitting them to remain in use. In France, perhaps 4000 individuals were infected. Three French officials were charged: the former Premier, Laurent Fabius; his superior at the time, the Social Affairs Minister Georgina Dufoix; and the Health Minister responsible for oversight, Edmond Hervé. At the core of the charge of negligence was that the three had delayed introducing the US blood-screening test into France until a rival French product was ready to go on the market. Hervé was convicted of negligence for HIV acquired by two recipients of the products, but the court failed to hand down punishment. Still, at least there was public recognition of official responsibility (BBC News, 1999). In Japan, more than 1400 hemophiliacs were exposed to HIV and at least 500 died as a result. The scandal raised a national outcry about whether the Japanese Government's health bureaucracy was too tied to the pharmaceutical industry, and thereby put profits over people. Akihito Matsumara, head of the Government Ministry responsible for handling blood and blood products, was charged with negligence and given a suspended one-year sentence for the death of a patient who in 1986 contracted AIDS from a contaminated transfusion. By that time, heat treatment to sterilize blood replacement products from HIV had been in place in the United States for two years (BBC News, 2001).

A much larger epidemic of HIV, hepatitis, and possibly other infectious diseases may have occurred in China as a result of unsafe practices by unscrupulous private blood collection companies too closely linked with government officials. These enterprises operated in Henan, Anhui Shaanxi, and Hebei provinces, where mostly poor rural Chinese were paid to donate blood. They re-used non-sterile blood collection equipment between donors and re-infused repeat donors with potentially tainted blood in order to reduce their symptoms of anemia and get them to donate more often. So far there has never been a full surveillance program to document the extent of the epidemic, but it could be very large, because the combined population of these provinces is about equal to that of Western Europe. Not only are the donors at risk, but also their sexual partners. Activists who protested that there was a Government cover-up were beaten and jailed. In February 2002, proof of official Government participation in the blood donor scheme appeared in the form of a videotape sent to the United Nations, the PRC Ministry of Health, and the news media. It showed 20 villagers' blood donor cards that had been issued by the Henan Ministry of Health, and that the individuals had been allowed to be repeat donors. It was not until March 2004, approximately seven years after the beginning of the epidemic, that the national Ministry of Health acknowledged that transmission of HIV had occurred in the 1990s due to blood collection. To date, no individual Chinese official has been held responsible (Agency France Press, 2004; Wan and Li, 2007).

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