The Weekly Update - 9th October 2009

Welcome to this week's installment of the Medical Law and Ethics Blog. In this post we will be considering organ donation as well as clinical negligence. A brief announcement the Human Fertilisation and Embryology Act 2008 concludes proceedings. All in all, a real mixed bag.

Organ Donation

Both 'Telegraph.co.uk' and 'news.bbc.co.uk' ran a story this week highlighting an increase in the number of Britons who have signed onto the organ donor register (see Anon 'Organs Still Short as Donors Rise', news.bbc.co.uk, 7th October 2009 http://news.bbc.co.uk/1/hi/health/8295764.stm and Smith, R. 'One in Four Britons on Organ Donor Register', Telegraph.co.uk, 8th October 2009 http://www.telegraph.co.uk/health/healthnews/6268495/One-in-four-Britons-on-organ-donor-register.html).

Official figures released by the Organ Donation Taskforce show that more than one in four Briton's is now on the organ donor register, a rise of 6.5% from last year's figures. This, in turn, has led to an increase in the number of transplants carried out in the same period. However, all is not rosy.

It is reported that the United Kingdom's donor rate lags behind that of much of Europe. Part of the issue relates to the system of consent underpinning any decision to remove organs from a deceased individual for transplantation, as governed by the provisions of the Human Tissue Act 2004.

If the individual has already clearly expressed their wish to consent to the withdrawal of their organs, and there is a clear record of the deceased's wishes then the family of the deceased do not have the legal power to veto or overrule the deceased's decision. Of course, this is an issue that needs to be dealt with very sensitively.

If there is no clear record of the deceased's wishes, and the deceased is a potential donor, then it falls to trained healthcare professionals to approach the deceased's partner/family/close friends to raise the issue of donation and ascertain whether there is anyone within that group who is willing to authorise the removal of organs for transplantation who has the power to do so under the provisions of the Human Tissue Act 2004.

The Human Tissue Act 2004 identifies two classes of individual who can give a valid consent to the retrieval of organs for the purposes of donation. First we have 'nominated representatives'. These are individuals who were nominated by the deceased as someone who has the power to represent them after their death and give a consent on their behalf. If there is more than one 'nominated representative' in existence then consent only needs to be obtained from one of them. Crucially, if a nominated representative exists, and they have consented to the retrieval of the deceased's organs for transplantation, this consent cannot be overridden by family members or anyone who falls within the second category, i.e. persons who are in a qualifying relationship.

If there is no evidence that the deceased had previously consented to donate their organs, or if there is no 'nominated representative', or if there is a 'nominated representative' but it is impractical to make contact with the 'nominated representative' (e.g. because time is really of the issue if the organs are to remain fit for transplant'), then (and only then) consent to the retrieval of the deceased's organs for donation can be given by anyone who is in a 'qualifying relationship ' with the deceased. Those who may be in a 'qualifying relationship' with the deceased are:

1. The spouse or partner (including civil or same sex partner);
2. Parent or child (the child can be of any age and can be a natural child or an adopted child);
3. Brother or sister;
4. Grandparent or grandchild;
5. Niece or nephew;
6. Stepfather or stepmother;
7. Half-brother or half-sister;
8. Friend of long standing.

This is a hierarchical list. Consent only needs to be obtained from one of the parties on the list, however, it should be obtained from the person highest up the list (e.g. if the deceased has no partner and is not survived by their parents or a child, then consent can be given by a sibling). Crucially, if consent is sought from the highest ranking person in the list and consent is refused, consent cannot subsequently be sought from someone lower down in the list (e.g. in the example we have just considered, if the deceased's brother refuses to consent to the retrieval of the deceased's organs for donation, it is irrelevant that the deceased's nephew is preparared to give consent).

There are just a few more points to be made in relation to the 'qualifying relationship' hierarchy. It is possible to omit certain persons from the list in some circumstances, namely if:

1. They do not wish to deal with the issue of consent;
2. They are not able to deal with the issue (perhaps because they lack capacity); or
3. It's not practical to get into contact with the individual within the time available if the organs are to remain suitable for donation.

So, to give a different example, if the hospital's transplant coordinator tries to contact the deceased's wife, but despite their best efforts the wife cannot be contacted and time is running out, consent can be given by the deceased's children. But what if the deceased has more than one child? The rules on this are clear, if there are multiple persons within a category who might be deemed to be in a 'qualifying relationship', consent is only needed from one of them. Thus, if the deceased in the example just given had three children, the transplant coordinator would only need to obtain consent from one of the children.

For more information on the law governing the retrieval of organs for transplantation (from both live and deceased donors), access a copy of the Human Tissue Act 2004. You may also find it helpful to access the Code of Practice issued by the Human Transplant Authority in order to help those affected by the provisions of the Act understand the steps they need to take to remain compliant with the law when dealing with potential donors (Human Tissue Authority 'Code of Practice 2 - Donation of Solid Organs for Transplant' http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code2donationoforgans.cfm)

So, where the deceased has made their decision to consent to the removal of their organs perfectly clear there is little problem, but where the deceased has failed to leave clear evidence of their intentions there is a distinct possibility that the 'nominated representative' or the person in a 'qualifying relationship' will refuse to consent to such a removal on the patient's behalf. Indeed, organs are only retrieved from a third of potential donors owing to the great tendency of those in a position to give such a consent to refuse it.

It is within this context that calls have been made to adopt a system of presumed consent. In simple terms under such a system we would all be presumed to have consented to the retrieval of suitable organs from our bodies upon our death. In order to rebut such a presumption we would have to take positive action and opt out of becoming an organ donor (at present we are required to opt in, a small but significant distinction). Such a system was advocated by the Chief Medical Officer, Sir Liam Donaldson, in 2006 in his annual report (Donaldson, L. 'On the State of Public Health: Annual Report of the Chief Medical Officer 2006' (London: TSO, 2006) http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/AnnualReports/DH_076817) in a chapter called 'Organ Donations: The Waiting Game'. More recently the Chairman of the British Medical Association's Ethics Committee, Dr Tony Calland, has also called for a 'serious debate' about adopting a system of presumed consent in relation to organ donation (BMA Press Release 'Increase in Donors is Good News, Say Doctors, But More Needs to Be Done', 8th October 2009 http://web2.bma.org.uk/pressrel.nsf/wlu/SGOY-7WLKCH?OpenDocument&vw=wfmms).

Why not take a moment to comment on this post and share your views on whether we should look to adopt an opt-out system of consent?

Why Hospital is a Dangerous Place to Be

I have shamelessly pinched this headline from a story which appeared in Independent this week and was also covered in 'The Times Online' and 'news.bbc.co.uk'. All three stories picked up on figures published by the National Patient Safety Authority (NPSA) detailing the number of patient safety incidents and near misses across the National Health Service in the period between 1st October 2008 and 31st March 2009 (the full set of reports are available online at http://www.nrls.npsa.nhs.uk/patient-safety-data/organisation-patient-safety-incident-reports/).

The figures show that there were a total of 459,500 patient safety incidents in the report period - the highest figure since records began - a rise of 12% on the previous year. Of course it should be noted that the reporting scheme run by the NPSA is a voluntary scheme, thus the rise in the number of mistakes reported to the NPSA year on year can partly be explained by the fact that more and more trusts on board (currently 382 of the 392 trusts report to the NPSA). Similarly it is recognised that those trusts with the highest level of incidents tend, irnonically to be the safest. This can be explained on the basis that these trusts have established a culture of openness in which mistakes are reported and lessons are learnt. Nevertheless the breakdown of the figures show:

• There was no harm to the patient in relation to 303,016 patient safety incidents;
• 122,246 of the patient safety incidents resulted in low harm to the patient;
• Moderate harm was suffered by 28,521 patients involved in a safety incident; and
• 5,717 of the patient safety incidents resulted in death or serious harm (e.g. permanent injury or disability).
• As reported in Anon 'NHS Mistakes Harming Thousands', news.bbc.co.uk, 7th October 2009 http://news.bbc.co.uk/1/hi/health/8295417.stm and Rose, D. 'Errors by NHS Staff Led to 5,700 deaths in Six Months, Report Says', Times Online, 8th October 2009 http://www.timesonline.co.uk/tol/life_and_style/health/article6865050.ece.

Furthermore:

• The vast majority of the safety incidents (32.8%) were accidents involving patients (e.g. where the patient slipped or fell);
• 10.1% of the patient safety incidents were errors or near misses with treatments or procedures (e.g. whilst inserting a catheter); and
• Medication errors accounted for 9.4% of the patient safety incidents.
• As reported in Rose, D. 'Errors by NHS Staff Led to 5,700 deaths in Six Months, Report Says', Times Online, 8th October 2009 http://www.timesonline.co.uk/tol/life_and_style/health/article6865050.ece and Laurance, J. 'Why Hospital is a Dangerous Place to Be', The Independent, 7th October 2009 http://www.independent.co.uk/life-style/health-and-families/health-news/why-hospital-is-a-dangerous-place-to-be-1799083.html.

Of course there is nothing to say that all of these incidents can be attributed to negligence, we must be prepared to accept the fact that every once in a while harm will materialise despite the best efforts of those involved in caring for the patient. What worries me about these fgures, however, is that for all the talk of 'learning from mistakes' and 'ensuring these types of error do not occur again' it always seems to be the same categories of error that are the most prevalent. Indeed it was only in 2007 that the NPSA published the report 'Slips, Trips and Falls' (accessbile at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59821) designed to improve understanding of the scale of the problem in the NHS, the impact the large volume of falls had on both the patient and the NHS and the sorts of steps that might be taken to help reduce the number of incidences of patient slips, trips and falls.

This brings us back to the same old question, is the NHS truly capable of learning from it's mistakes? Answers on a postcard to the usual address ...

... and Finally, the Human Fertilisation and Embryology Act 2008

This technically counts as old news (it should have been in last week's blog). I just wanted to make you aware (in case you were not already) that the Human Fertilisation and Embryology Act 2008 came into force on the 1st October 2008. Expect further discussion about the contents of the Act in the near(ish) future.