Tuesday, June 05, 2007

Informed consent for transfusions - take this job and shove it?

If you know someone who has had a transfusion recently, ask them if a physician or nurse explained the risks and benefits and, if during or after their hospital stay, they were notified in writing that they were transfused. Chances are, maybe not, even though both policies have been promoted as best practice for years now.

In Canada more than a decade ago Justice Krever (Commission of Inquiry on the Blood System in Canada), made recommendations on informed consent and documentation:

To quote Capen:

  • In March 1995 the Krever inquiry released an interim report, which contained a strong warning that the informed-consent requirement applies specifically to the administration of blood or blood products, and the routine consent form signed upon admission to hospital does not fulfil this requirement.
  • It also said physicians should prepare patients well in advance of scheduled surgery to give them adequate time to consider reasonable alternatives.
  • As well, doctors should provide information on these alternatives.
  • The interim report said doctors must ensure that documentation occurs every time consent is provided, and that all treatments or procedures are recorded in the chart.
Despite inclusion in blood safety standards, many transfusion services in Canada and around the globe are still developing processes for informed consent and documented notification of transfusion. A paper by Canadian authors and editorial in the April issue of Transfusion deal with these related issues:

  • Killion DF, Schiff PD, Shoos Lipton K. Informed consent: working toward a meaningful dialogue (editorial) Transfusion 2007 Apr;47 (4), 557-8.
  • Rock G, Berger R, Filion D, Touche D, Neurath D, Wells G, Elsaadany S, Afzal M. Documenting a transfusion: how well is it done? Transfusion 2007 Apr;47(4):568-72.
In brief, Rock and coworkers did a retrospective review of 1005 patient charts with these results for documentation of informed consent and transfusion:

  • In 75% of cases the physician had not documented that any discussion had occurred regarding the risks and/or benefits or alternatives.
  • Only 12% of charts included information that patients were subsequently told what blood components were transfused.
  • The discharge summary recorded transfusion information in 32.1% of cases whereas the consult note had this information in 26.3%.
If informed consent is still not a reality, why not? The editorial authors propose as possible mitigating factors (1) distressed patients in pain and (2) health professionals who are rushed. They offer the following suggestions as a follow-up to the Rock study:

  1. Perform more studies to determine how widespread informed consent is
  2. Change the current model of informed consent so that, instead of relying heavily on physicians, who bear ultimate legal responsibility for transfusion, trained transfusion staff be used to obtain informed consent.
The advantages are that transfusion staff understand the risks and benefits of transfusion, as well as patient needs, and are better equipped to follow through with documentation.

To meet best practice standards most transfusion services in Canada are actively promoting informed consent and documentation:

Informed consent for transfusions - whose job is it, anyway? Is the answer to change the model and shift obtaining informed consent to trained transfusion staff? And who would these staff be? Nurse transfusion specialists? Transfusion safety officers, whether medical laboratory technologists or nurses? In some Canadian hospitals nurses already handle informed consent. What problems may this shift to transfusion staff potentially create for physician responsibility for transfusion when the inevitable mistakes are made?

In pondering the issue of shifting responsibility for informed consent, I could not help but think of a shift in responsibility that happens in some rural hospitals. In towns where the laboratory is not staffed after hours by technologists, nurses are asked to issue blood from the transfusion service. Presumably they are trained in issuing procedures, but how well is open to debate. And in some locales nurses have refused to issue blood, claiming it is an effort to shift work from the laboratory to the nursing staff, in effect making nurses subsidize the lab service, which saves money by not running the lab after hours.

Is the suggestion of a new model as proposed by the Transfusion editorial another example of offloading responsibilty to others, others who are supposedly less busy than physicians? Or is this view too cynical? With patient safety coming first (not politics), is the proposed model simply a pragmatic view - do what works best for the patient. Regardless, any new model must proactively deal with potential problems caused by a shift in responsibilty for informed consent to transfusion staff.

Lastly, how representative is the Rock study of Canadian hospital performance in obtaining informed consent from patients and providing written documentation of transfusion? We can only speculate. If you are not Canadian and think your hospitals perform better, my quess is, think again. The problem is likely widespread in the USA, the UK, and elsewhere. You will not know without extensive audits.

Clearly, much work remains to be done in fulfilling some of Justice Krever's most basic recommendations. In the meantime, informed consent seems to a case of take this job and shove it!

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