The safety of blood transfusions: are the procedures used to monitor Australia's blood banks adequate?

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The safety of blood transfusions: are the procedures used to monitor Australia's blood banks adequate?

Echo Issue Outline 1999 / 24-25: copyright © Echo Education Services
First published in The Echo news digest and newspaper sources index.

Issue outline by J M McInerney

What they said ...
'We can assure Australians that our blood transfusion services are [among]... the safest in the world, if not the safest'
Dr David Brand, president of the Australian Medical Association

'The era of having blind faith in a doctor or system is gone'
The father of the child infected with HIV through a blood transfusion

On July 28, 1999, it was made public that a Melbourne school girl had contracted HIV through a blood transfusion.
Though the child's identity has been protected, her case has been made public in an attempt to ensure that all measures possible are taken to prevent this happening again.
Her father, a surgeon, was also concerned to promote directed donations.
Prior to their daughter's surgery, both he and his wife had sought to make a directed donation, that is, to donate blood specifically for their daughter's use. Victorian transfusion policy does not generally allow this practice and so they were refused.
There are currently three inquiries investigating the circumstances surrounding this event. One, called by the federal health minister, has been in existence since May and has had its terms of reference expanded to include the factors contributing to this recent tragedy.
There has been substantial debate in the media about the safety of Victoria's and Australia's blood supply and about the appropriateness of directed donations.

Background
Currently, blood donations in Australia are screened for syphilis and hepatitis B surface antigen.
They are also screened for antibodies for HIV types 1 and 2, hepatitis C virus and human T-cell lymphotropic virus (HTLV) types I and II.
Manufactured plasma products (such as clotting factor concentrates) undergo viral inactivation processes during their manufacture.
These manufactured plasma products therefore have an even greater degree of safety than cellular blood products, such as whole blood.
The screening of blood donors and modern blood product manufacturing techniques have greatly reduced the risk of transmission of serious disease by transfusion.
As of next year a new, more sensitive test is to be introduced to screen for HIV. This will detect the presence not of the antibody produced in response to an HIV infection but of the virus itself.
In addition to the screening of blood donations and the use of antiviral processing for plasma products, blood donors have to complete questionnaire of some 50 items, designed to indicate if they are in a group at risk of HIV infection. If they are they will not be able to donate blood.
Potential donors are also interviewed for suitability after they have completed the questionnaire.
Australia began testing blood donations for HIV in 1985 and was one of the first countries in the world to do so. Prior to that a significant number of Australians had been infected with HIV through transfusions or treatment with other blood products.
Changes were made to the Victorian Health Act in 1990 to protect the Blood Bank and hospitals from legal action taken by patients infected through transfusions.
Other states made similar legislative changes.
This was in response to some 460 claims from people given HIV-infected blood in the early 1980s.

There are a number of Internet sites with information relevant to this issue.
A good place to start is with the Australian Red Cross home page. This can be found at http://www.redcross.org.au/
The subsection of this site dealing with blood services can be found at http://www.arcbs.redcross.org.au/
This subsection includes a list of the questions asked of potential donors to gauge if they are likely to have HIV and other infections.
These questions can be found at http://www.arcbs.redcross.org.au/donating.htm
The subsection also includes a history of blood transfusion which can be found at http://www.arcbs.redcross.org.au/history.htm

The Australian Medical Journal(AMJ) on line has published a number of articles dealing with testing Australia's blood supply.
Two are detailed here. They are each informative and interesting, but will require careful reading as they are quite technical.

In 1998 the AMJ on line published an article titled Should we be screening blood donors for hepatitis G virus? The case against screening
It was written by Ping-Yee Wong, Patrick J Coghlan and Peter W Angus
It is of interest because it indicates some of the factors that influence decisions as to whether to apply a particular test to Australia's blood supply.
The recommendation here that the test not be applied appeared to be based primarily on the fact that the virus does not seem to produce a disease state in those infected with it.
The article discusses factors such as the cost of testing and whether hospitals and blood banks were likely to be successfully sued by transfusion recipients infected with the hepatitis G virus.
The article can be found at http://www.mja.com.au/public/issues/oct5/wong/wong.html

In 1997 the AMJ on line published an article titled Is screening of Australian blood donors for HTLV-I necessary? It was written by Gordon S Whyte
HTLV-I is human T-cell lymphotropic virus type I. It has been associated with T-cell leukaemia and with T-cell lymphoma. The prevalence of HTLV-I in Australian donors is said to be 1 in 100 000 and the calculated risk of a transfused patient developing HTLV-I disease is said to be 1 in 9 to 15 million.
The article makes no clear recommendation as to whether testing for HTLV-I in blood donors should continue, instead it suggests three possible future courses of action. One of these is to discontinue testing.
It includes the judgement, 'Stakeholders (Australian Red Cross Blood Service, State and Federal governments and the community) would be assisted by public discussion of an acceptable level of risk and appropriate level of screening for rare transfusion-transmitted diseases.'
This is interesting because it suggests that the public may need to accept that some level of risk should actually be allowed for in blood transfusions.
The article can be found at http://www.mja.com.au/public/issues/may5/whyte/whyte.html

HIVInSite is an extensive public information site developed by the University of California, the AIDS Program at the San Francisco Hospital and the UCSF Centre for AIDS Prevention Study and AIDS Research Institute.
HIVInSite has a subsite titled Transmission of HIV by Blood, Blood Products, Tissue Transplantation, and Artificial Insemination
The subsite can be found at http://hivinsite.ucsf.edu/akb/1997/01txbld/index.html
This subsite is detailed and quite technical but supplies a wealth of information about the tests currently being used to detect HIV in United States blood donors. It also looks at another, more sensitive test, which is being developed and may be used at a later date.
The subsite offers the interesting estimate that the change from testing for HIV antibodies to testing for the HIV antigen is likely to have detected an additional 5 to 10 infected donations per year out of the 12 million donations made annually in the United States.

Florida Blood Services, which allow directed donations, have a section of their site dealing with the procedures that are followed.
This can be found at http://www.fbsblood.org/directed.asp
Florida Blood Services also appear to encourage autologous blood transfusions, in which patients receive blood they have previously donated specifically for their own use.
The Services' information on autologous blood transfusions can be found at http://www.fbsblood.org/auto.asp

Arguments suggesting regulations and practices for collecting and transfusing blood are inadequate
A number of criticisms have been made of Australia's procedures for taking blood donations.
One of the criticisms of the protocols followed in collecting blood is that the blood banks do not appear adequately to acknowledge that unprotected heterosexual intercourse can be a risk factor.
It has been noted that the detailed questionnaire that potential donors have to complete as an indication of their suitability does not ask about unprotected heterosexual intercourse with a partner of unknown sexual history.
It has also been claimed that this question is generally not asked in the interview which is given after the questionnaire has been completed.
This claim has been made by Dr Colin Hughes, the spokesperson for the Australian College of General Practitioners.
Dr Hughes has claimed that the interviewing of those who wish to give blood has become less thorough.
Dr Hughes has claimed, 'We get them to check a checklist and we assume that because they answer the questionnaire properly we don't ask the question: "Have you had unprotected sexual intercourse in the last three months with a person you do not know the sexual history of?""
The same general point has been made by Dr Nick Crofts, the head of epidemiology at the Macfarlane Burnet Centre for Medical Research.
Dr Crofts has suggested that the community must become more aware that sexually active heterosexuals are at risk of contracting HIV.
'It not a huge risk, but it's an unpredictable risk,' Dr Crofts has said. 'You can't tell which of your sexual partners might have been at risk and got infected.'
The implication appears to be that blood banks should be playing a major role in ensuring potential donors recognise the hazards of unprotected heterosexual intercourse, other than in established, monogamous relationships.
Relatedly, Jill Singer, a commentator for The Herald Sun, has asked, '... if [the donor whose blood was infected with HIV] did not consider herself at risk, why did she have an HIV test two weeks after donating blood?'
Jill Singer appears to be suggesting that had this donor been more thoroughly questioned at the blood bank, she or the blood bank may have had doubts about her status and the donation would not have been made.
Another criticism that has been made of the procedures folowed by Australian blood banks is the claim that the tests which are used to screen out infected donor blood could be more effective.
The test currently used to determine if a donor carries HIV picks up whether the donor's blood has antibodies produced in response to the virus.
These may not appear in the blood until some 22 days after a person has been infected. There is, therefore a 22-day 'window' during which, using current methods, infected blood may appear safe for transfusion.
Next year Australia will be introducing NAT, a test which actually detects the presence of the virus, not the antibodies produced to fight it. This is referred to as antigen testing.
This new test narrows the window to approximately 11 days, or half the current period.
Jill Singer has argued, 'If Australia had ... introduced testing that effectively halved the widow period of detection, there is a good chance that the child at the centre of this ... tragedy would have escaped infection.'
Jill Singer has further suggested that Australia could have introduced the antigen test earlier but chose not to do so.
Ms Singer has claimed, '... in March 1996 the American Food and Drug Administration licensed antigen testing for HIV and on the very same day, Red Cross introduced antigen testing for HIV in America's blood supply.'
Ms Singer goes on to conclude that for the last three years the United States has operated with a 'window period' for the use of infected blood which is half that of Australia.
Ms Singer claims that the reason Australia is not currently using the more sensitive test 'is because antigen testing is more expensive than antibody testing'.
Ms Singer further argues, 'A US report by the Institute of Medicine describes a nation's blood supply as an "expression of its sense of community". By not doing more to protect recipients of blood transfusions in this country, our sense of community is seriously drawn into question.'
A major criticism which has been made of the Victorian Red Cross, rather than of blood banks across Australia, is that in Victoria 'directed donations' are only allowed in limited and highly specific circumstances.
A 'directed donation' occurs when someone, usually a family member or friend of the intended recipient, makes a donation specifically for that person's use.
It is possible to make directed donations in New South Wales, South Australia and Tasmania.
Critics object to the inconsistency and to the recent change in Australia's procedures.
It has been claimed that it was possible to make directed donations in Victoria up until 1996 at which time the Victorian Red Cross Blood Service changed its policy and decided against them.
Victorian hospitals then apparently followed suit and similarly disallowed directed donations.
Critics of the current policy in Victoria argue that its prohibition of directed donations is unnecessary.
They argue that there is no conclusive evidence that donor directed transfusions represent a greater risk; in fact they suggest that these transfusions are likely to represent a lesser risk.
Supporters of directed donations claim that those who give blood directly to those they know have an even higher motivation than members of the general community to ensure that they are suitable donors. It is argued that this is especially the case where parents are donating blood to be used by the children.
Mr Tonti-Fillipini, a bio-ethicist, has suggested, 'You are likely to be more honest about these sorts of difficult questions if there is a chance you could risk the life of your child.'
Some critics have suggested that the reason Victoria has prohibited donor directed transfusions is that they are more difficult to administer and so more costly.
It has also been claimed that directed donations should be a matter for the informed choice of patients.
According to this line of argument, if the reasons for and against directed donations are explained to potential recipients and their families then the decision as to whether this is their preferred option should rest with them.
This point was made in an Australian editorial of July 29, 1999, titled Patients must have power to judge risks.
Finally, it has been argued, that given that there is some level of risk associated with blood transfusions, doctors and blood services have a responsibility both to better inform patients of these risks and to offer them other alternatives, where appropriate.
This point has been made by Dr Colin Hughes, a spokesperson for the Australian College of General Practitioners.
Dr Hughes has claimed that patients are generally not told of other options such as bloodless surgical techniques and artificial blood transfusions.

Arguments suggesting regulations and practices for collecting and transfusing blood are adequate
Those who maintain that Australian regulations and procedures for collecting and transfusing blood are adequate usually begin by pointing out that no blood supply can be made completely safe.
This point has been made by Dr Patrick Coghlan, the director of Victoria's Red Cross blood bank.
Dr Coghlan has claimed, 'We have never promulgated the idea blood is 100 per cent safe.'
However supporters of our current procedures then go on to point out that Australia's blood supply is very safe, and further, that it is as safe as it can reasonably be made to be.
This point has also been made by Dr Coghlan who has noted, '... the risk is so low you have to keep it in perspective and it's far more dangerous not to have a transfusion when you need one.'
A similar assurance has been given by Dr David Brand, president of the Australian Medical Association.
Dr Brand has stated, 'We can assure Australians that our blood transfusion services are one of the safest in the world, if not the safest.'
With regard to the specific risk of contracting HIV from a blood transfusion it is claimed that the risk is somewhere in the vicinity of one in 1.2 million.
It has further been noted that the recent infection of a primary school-aged child with HIV through a blood transfusion is the first such case known to have occurred since the Australian Red Cross began testing donations for HIV in 1985.
It has further been noted that the HIV-bearing blood which the child received was donated during a period when current testing procedures are unable to detect the presence of the virus.
Current testing for HIV detects the presence of antibodies the body produces to combat the virus.
These can take some 22 days to appear after the infected person has contracted the virus. This means that there is a 22 day 'window' period during which the virus is undetectable but able to be transferred through transfusions.
The Red Cross is aware of this 'window' and claims that it attempts to guard against the possibility of blood being donated by an HIV-positive person by having all donors answer a series of questions which indicate whether they are at risk of contracting HIV.
The woman who donated the infected blood answered these questions, was a regular blood donor whose donations had always previously been uninfected and did not appear to practise any of the behaviours likely to lead to contracting HIV.
Dr Patrick Coghlan, Victorian director of Red Cross blood services has said, 'This tragic event is the expression of the limits of safety using all approved tests and procedures.
'There was no fault in any of the procedures carried out by the Blood Bank or the hospital.
'All appropriate infection control measures were observed.'
With regard to the suggestion that there is a more sensitive HIV screening test which reduces the window period to some 11 days, defenders of Red Cross procedures note that the new test will be in use in Australia as of next year, and further, that in this particular case of transfusion transmitted HIV, the more sensitive test would still not have detected the presence of HIV as the donation appears to have been made during what would be the 'window' period of the new test.
It has also been suggested that there may come a time when the cost-effectiveness of certain blood-screening procedures has to be considered.
For example, the new screening test for HIV to be introduced next year is estimated to add $30 million dollars a year to screening costs.
It is further estimated that the new test will reduce the risk of transfusion-borne HIV infection from one person in 14 years to one in 30 years.
On this reckoning it would cost $900 million to save one life.
Bill Birnbauer, writing in The Age, has suggested that $900 million 'could save many thousands if spent on public health programs'.
On the question of directed donations, the Victorian branch of the Red Cross has defended its policy decision only to allow them in highly limited circumstances.
The Victorian Red Cross claims there are studies which suggest that directed donations are more risky than anonymous, voluntary donations.
According to this line of argument, family members and other donors known to the recipient are as likely to be infected with HIV or other blood-borne diseases as any other member of the community.
This point was made in an Australian editorial of July 29, 1999.
The editorial claimed, 'Directed donors can still offer infected blood because of the 22 day window.'
It is further argued that because of their connection with the recipient relatives or family friends may feel under particular pressure to give blood.
In addition, it is claimed, because these known potential donors are not giving anonymously it may be more difficult for them to answer the donor questionnaire honestly.
The examples that are often given is that it may be difficult for the father of a child to admit to having had homosexual contact or for either parent to admit intravenous drug use.
This point has been made by Dr David Brand, the president of the Victorian branch of the Australian Medical Association.
Dr Brand has claimed, `[directed donations] put a lot of pressure on relatives to donate blood and they are not necessarily as forthcoming with risk factors.'
It is also claimed that there are some risk factors that are particular to directed donations to children from either parents or other close relatives.
There is apparently the possibility that blood donations from parents to female children could, in the future, put that child's pregnancies at risk.
With regard to the proposition that patients should be able to choose their preferred source of a transfusion, some doctors have argued that if the best evidence suggests that directed donations are less safe, a hospital would be irresponsible to allow patients to determine that they would have one.
This point has been made by Dr John de Campo, the chief executive of the Women's and Children's health care network.
Dr de Campo has said, 'Legally all medical practioners have a responsibility to do what is in the best interests of the child - that is an absolute requirement and in almost every circumstance parents agree with that because they know it is based on knowledge and fact.
'Hypothetically, if parents refuse the best advice and it's known tp be in the best interests of the child ... We couldn't do that; we would have to refuse.'
With regard to the father of the child who was infected with HIV via a blood transfusion, it appears he had previously been rejected as an anonymous, voluntary donor because as a surgeon he was regarded as in a high risk category.
(Surgeons may contract HIV from infected patients through stick injuries.)
Finally, it has been suggested, that encouraging directed donations could discourage the voluntary, anonymous donors upon whom the blood bank system necessarily relies.

Further implications
The most immediate consequence of news being released that a young girl had contracted HIV through a blood transfusion was that the number of donors visiting blood banks increased.
There seemed to be an immediately increased awareness among donors of the need for reliable supplies of uninfected blood.
There are three inquiries currently taking place into the safety and other features of Victoria's and/or Australia's blood supplies. The federal inquiry, which is more general, had been set up a month and a half before news of the girl's infection was made public.
It remains to be seen what will be the upshot of these inquiries.
One of their concerns is likely to be the apparent inconsistency across the states regarding directed donations. They are allowable in New South Wales, Tasmania and South Australia, but not in Victoria and the Northern Territory.
Given that research into the safety of directed donations has not yielded uniform results it is uncertain what overall policy will be agreed upon. It is not impossible that it will be decided that all states will prohibit or at least severely limit directed donations.
It is likely that there will be an increased effort to inform the public about the possible risks of blood transfusion and a particular effort to inform donors of their HIV and other disease risk factors.
The issue of HIV infection through unprotected heterosexual intercourse is likely to be addressed more directly.
Given that part of the brief of the federal inquiry is to look at the relative shortage of blood donors and repeat donors, it is likely that there will be a popular education campaign to try to overcome this. It is even possible that employers will be given some sort of incentive to allow interested employees to donate during working hours. (Changing working hours have been suggested as one reason for the decline in donors.)
It is also possible that options that will reduce the number of whole blood transfusions, such as bloodless surgery and artificial blood transfusions, will be more actively pursued. People may also be encouraged to make autologous blood donations, that is, to donate blood for their own use.

Sources
The Age
11/5/99 page11 news item by Adrian Rollins, 'Minister orders blood bank inquiry'
28/7/99 page 1 news item by Mary-Anne Toy, 'Blood scare inquiry'
28/7/99 page 1 news item by Ann-Mary Toy, 'A risk one family did not want to take'
28/7/99 page 6 news item by Chleo Saltau, 'Safety depends on honesty of donors'
28/7/99 page 6 news item by Nicole Brady, 'Policy review to look at national framework'
28/7/99 page 6 news item, 'The panic has gone but the fear remains'
28/7/99 page 6 news item by Darren Gray, 'Federal blood inquiry already underway'
29/7/99 page 1 news item by Mary-Anne Toy, 'Father attacks blood inquiry'
29/7/99 page 4 news item by Carolyn Webb, 'Families can donate interstate'
29/7/99 page 4 news item by Darren Gray, 'Australia at forefront in battle against HIV'
29/7/99 page 4 news item by Lyall Johnson, 'New HIV test detects virus itself'
29/7/99 page 4 news item by Chleo Saltau, 'Court victory dubious: lawyers'
29/7/99 page 18 editorial, 'Blood donation system not risk-free'
29/7/99 page 18 letter from Lee Stapleton, 'A parent's right to give blood'
29/7/99 page 18 letter from Andrea Lewis, 'In support of the blood bank'
30/7/99 page 2 news item by Mary-Ann Toy, 'Second couple won right to give daughter blood'
30/7/99 page 2 news item by Darren Gray, 'Life at the edge for blood banks'
31/7/99 page 3 (News Extra) analysis by Bill Birnbauer, 'Is screening in vain?'
31/7/99 page 3 (News Extra) analysis by Mary-Anne Toy, 'How directed donations raise blood pressure'

The Australian
28/7/99 page 4 news item by Rodney Dalton, 'Small risk to supply admitted'
28/7/99 page 4 news item by John Kerin, Monica Videnieks & Belinda Hickman, 'Bid for consistency on directed donations'
28/7/99 page 4 comment by the father of the girl given HIV through a transfusion of infected blood, 'Our worst nightmare came true'
28/7/99 page 4 analysis by Belinda Hickman, 'Young's odds improve least'
28/7/99 page 4 analysis, 'Your questions: the vein of truth'
28/7/99 page 4 analysis by Stuart Rintoul, 'Bitter lessons - but 'we did it better'
29/7/99 page 1 news item by Amanda Hodge, 'Surgeons and blood bank failed HIV girl, say GPs
29/7/99 page 4 news item by Amanda Hodge, 'Donor surge fails to allay shortage fears'
29/7/99 page 10 editorial, 'Patients must have power to judge risks'
30/7/99 page 3 news item by Amanda Hodge, 'Doctors wary of blood bank bias'
31/7/99 page 9 news item by Amanda Hodge, 'Blood system "can't be trusted"'

The Herald Sun
28/7/99 page 1 news item by Wendy Busfield, 'Our little girl's fight'
28/7/99 page 4 news item by Terry Brown, 'How a good intention went wrong'
28/7/99 page 5 analysis by Wendy Busfield, 'Virus slips through the net'
28/7/99 page 5 news item by Ruth Lamperd, 'Family blood better'
28/7/99 page 5 analysis by Terry Brown, 'Payout could be massive'
28/6/99 page 6 news item by Tanya Taylor, 'Distrust lingers'
28/7/99 page 7 comment by the father of the girl given HIV through a transfusion of infected blood, 'A family in torment'
28/7/99 page 7 news item by Wendy Busfield, 'Dad puts pain aside to tell'
28/7/99 page 9 comment by John Hamilton, 'Essence of giving'
28/7/99 page 18 editorial, 'A failure of the system'
29/7/99 page 2 news item by Tanya Taylor, 'Dangers in blood gifts to family'
29/7/99 page 3 news item by Wendy Busfield, 'Tragic girl's dad attacks probe'
29/7/99 page 3 news item by Sarah Dent, 'PM raises privacy law overhaul'
29/7/99 page 18 editorial, 'Blood relations'
29/7/99 page 18 comment by Andrew Bolt, 'A sad, shocking truth'
30/7/99 page 18 comment by Jill Singer, 'There are still a lot of questions for the blood bank'
31/7/99 page 12 news item by Wendy Busfield, 'Doctor's blood too risky'