Documentation: Informed Consent in Patient Medical Record

POLICY:

 
All patients will have a signed informed consent form on the 
chart:
 
1.  Prior to the performance of an operative procedure for 
    any purpose (e.g., diagnostic, therapeutic, cosmetic);
 
2.  Prior to the initiation of anesthesia; and/or
 
3.  In situations where it is deemed advisable.
 
The purpose of this policy is to insure that all patients 
have been informed of the potential risks, consequences, and 
alternative treatment modalities involved in any anticipated 
procedure(s).
 


PROCEDURE:


The physician performing the procedure is responsible for 
explaining the proposed procedure to the patients and for 
informing patients of the following elements.  The concept of 
informed consent consists of a discussion of and 
documentation of the following; either in a progress note, 
form or elsewhere in the record.:
 
1.  The nature of the treatment
 
2.  The risks, drawbacks, complications, and potential 
    benefits or effects of the procedure, including 
    anesthesia;
 
3.  Any alternatives to the procedure and the risks and 
    benefits of such alternatives;
 
4.  Potential problems related to the recovery period;
 
5.  The likelihood of success;
 
6.  The possible result of non-treatment; and,
 
7.  The patient's ability to comprehend verbal informed 
    consent;
     -about the anesthesia or procedure and
     -the opportunity to ask questions regarding the 
      explanation.
8. Whether physician(s) other than the operating physician my
   be performing tasks such as closing, removing tissue,  
   etc.  
 
The consent form language is clear, simple and uses 
easily-understood terms.  
 
If consent was not accomplished during the pre-operative 
period, the patient will be asked to read and sign the 
consent form during the admission process;  Staff members 
will answer questions regarding the planned procedure, 
addressing other patient concerns.  Specific medical 
information will be referred to the surgeon, the anesthesia 
provider or qualified clinical personnel.
The consent form must be witnessed, with the signature of the 
witness entered onto the form.
 
Patients will receive a copy of each document signed as a 
part of the consent process.  Patients have the option of 
refusing to sign or requesting an additional consultation 
with the physician before signing.  The procedure will be 
cancelled if a patient refuses to sign the consent form.
 
Once signed, the informed consent has continuing force and 
effect until the patient revokes the consent or circumstances 
have changed which would affect the nature of, the risks of 
the procedure and/or the alternatives to the procedure for 
which the patient gave the consent.  For multiple sequential 
procedures, the patient will re-sign the consent form at 
regular intervals.
 
If it is noted that there is no consent in the record, an 
informed consent with information provided by the surgeon or 
in consultation with the primary surgeon will be provided to 
the patient.  Signature of patient will be obtained and 
witnessed by staff, who will insure that the consent form is 
accurately dated.  When a consent is obtained on the day of 
surgery, the time that the patient signs the consent form 
will be documented.
 
EXCEPTION:  In the event of a life-threatening surgical 
emergency, a signed consent for operative/invasive procedure 
is not needed.  The surgeon must document in the medical 
record why it was in the best interest of the patient to 
proceed without obtaining informed consent because the 
patient's condition represented a life-threatening surgical 
emergency.

Approved By Governing Board    
PR.5
Control #18.3
GUPTA GASTRO