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:
- Capen K. Informed consent and blood transfusions: what does Krever's interim report mean to doctors? CMAJ 1998 Jan 13;158(1):92-4.
- 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.
- 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 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%.
- Perform more studies to determine how widespread informed consent is
- 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.
To meet best practice standards most transfusion services in Canada are actively promoting informed consent and documentation:
- TraQ resource library - Informed consent
CHANGE THE MODEL?
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!
**Be sure to check out the "comments" section below.**
I think the current process of obtaining and documenting informed consent by physicians is fatally flawed. Although the decision and responsibility regarding transfusion (as the best therapy in a given situation) rests with the ordering physician the ordering doc likely doesn't have the details of transfusion risk at hand. The sick patient probably doesn't want too many details in most cases ("do what ever is best doc") - and the doc doesn't want to "document informed consent" when the patient didn't have a discussion.
ReplyDeleteI am a Transfusion Medicine Physician - and after years of badgering, cajoling, pleading, and explaining the rationale and process of obtaining informed consent to physician colleagues - I am ready to give up and change the process. In my experience, when documentation and discussion (or at least information) occur with the patient it is because someone present at the time of transfusion (usually a nurse) took the time to provide information and document the patient's agreement to continue.
I don't think this is passing the buck. The doc remains "responsible" for all sorts of things related to the patient that he/she doesn't personally over see. Arguably, many of these things are less safe than transfusion yet they occur without a special procedure to document the discussion.
So, I say, lets do whatever works - and if training TM staff to do this job will get the education and information out there... then that is what we should do.
I have often thought that each Health Region should employ at least one Patient Advocate specializing in Transfusion Medicine. This individual's responsibility would be to provide information to the patient for the purpose of obtining informed consent, but also to ensure that the patient is aware of all of the treatment options available and the risks and benefits associuated with each option.
ReplyDeleteBy having these individuals belong to a Health Region, you would see equal application of informed consent rules applied in both urban and rural facilities. In regions where Transfusion Safety Offices exist, the Patient Advocate could be an integal part of that team. They could also sit on hospital transfusion committees in order to provide a patient centred perspective.