Informed Consent

Informed consent

Goals and objectives:

Be able to discuss the difference between “reasonable physician” and “reasonable patient” standard

These are legal standards for informed consent. It refers to what a reasonable physician should explain to a patient vs. what a reasonable patient would want to know about the procedure. This varies by state. New York is a "reasonable patient" state.

Be able to explain the rationale for each sentence in the consent note (and use a note which contains these elements in the future)

Be able to explain why we should not give a detailed consent description in the report.

This should be completed before the procedure and signed with the time of signing. The hospital consent form should be completed as well. (This has limited utility in legal cases.)

Preprocedure “consent” note:

Procedure, lumbar puncture, discussed with pt and daughter. Benefits, alternatives (including no procedure), risks (including but not limited to “headache” requiring “blood patch") discussed. Questions answered. Consent signed.

Procedure, myelogram, discussed with pt and daughter. Benefits, alternatives (including no procedure), risks (including but not limited to “headache” requiring “blood patch”, "seizure") discussed. Questions answered. Consent signed.

It is important to document who was present when the consent was obtained. If not a legal requirement, it is prudent say to have the family decision maker/advocate present for any consent conversation. e.g. patient's child who is a physician/lawyer.

It is important to give the patient the option of "no procedure". Apparently lawsuits have been lost because of this issue.

When describing risks, when you use a specific phrase put that in quotes e.g. "stroke" means you said "stroke" as opposed to some vague euphemism like "adverse neurological outcome".

It is critical thay you give the patient an opportunity to ask questions and document this. Again, lawsuits have been lost because of this issue.

Post procedure note:

The point of this note is to document the (hopefully good) condition of the patient post procedure. It is important to write this note after the procedure is completed. Sample note:

Myelogram completed. Procedure was uneventful. CT and report pending. Pt tolerated procedure well.

Please note the discussion of the consent process in your report should be something like:

Informed consent was obtained.

Some residents and fellows try to duplicate the consent note (detailed description of your discussion including risks and benefits) in the report. This will invariably lead to slightly different versions of the consent. If there are differences and the case goes to court, you can be sure a slide of both versions will be displayed. For those that choose to only document a detailed description of risks and benefits in the report only, documenting what was explained to the patient after the complication potentially happened does not make you look good.

References

ACR Medical Legal Issues in Radiology (pp 5-13) (attached)

http://www.acr.org/~/media/ACR/Documents/PDF/Membership/Legal%20Business/MedicalLegalHandbook.pdf

AJR Article

AJR Am J Roentgenol. 1997 Jul;169(1):15-8. Malpractice issues in radiology. Informed consent. Berlin L.

http://www.ajronline.org/content/169/1/15.full.pdf

SLR Hospital Policy

http://apps.chpnet.org/chp-pnp/pnp-maintenance/SLR/Administration/A3-102_Informed_Consent.pdf

ACR-SIR Guideline

http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Informed_Consent_Image_Guide.pdf