by Dr. Aikaterina Assimacopoulos
Informed consent is a must prior to any elective procedure. After all risks, benefits and alternatives (r/b/a’s) are thoroughly explained consent can be given. An informed patient is one who understands the nature and purpose of the procedure as well as postoperative expectations of pain, recovery time, need for physical therapy, and any changes to physical appearance. Signed consent should be found in the patients EMR.
Informed Risk Assessment
Common surgical risks include the risk of infection, bleeding or damage to surrounding organs. If a minimally invasive approach is planned, the possibility to convert to an open procedure should be discussed. If the patient is to have an exploratory surgery, a risk is the possibility that nothing is found on exploration. In some cases, there is a potential the surgeon recognizes additional measures must be taken upon viewing the patient’s anatomy. In these cases, the surgeon is usually aware of this potential and should obtain consent and discuss r/b/a’s.
The benefit or likelihood of a positive outcome should be clearly and realistically defined. The patient should be aware of any alternative options and their r/b/a’s. This includes both more conservative methods of treatment such as medications, physical therapy, or injections as well as any alternative surgical approaches that may vary in method or invasiveness. For example, a vaginal vs. abdominal approach to hysterectomy or LINX vs. Nissen fundoplication methods for gastroesophageal reflux.
A signed consent form and statement should be uploaded in the chart. For example, “r/b/a’s discussed, patient expressed understanding, all questions asked and answered” should be documented in the chart. However, this does not necessarily mean the patient was properly informed. Often this statement is included as part of a provider’s template, without being consciously documented. Therefore, this raises the question of whether or not the conversation actually took place.
Because this discussion is verbal, it is difficult to use an audit trail to prove whether appropriate informed consent was obtained. However, an audit trail can be used to analyze other aspects of preoperative care which, if deficient, or incomplete, could support the notion informed consent was deficient as well.
What to look for in an audit trail
If surgical complications arose and the physician was concerned about the preoperative care provided, the physician could enter the patient chart after the fact and make additions to the patient’s chart. This is why it is necessary to get an audit trail that extends through the date the EMR is generated. Providers can alter a patients EMR at any time. These changes might not be visible on the EMR but will be on the audit trail.
In most cases, evidence of the following actions should exist in both the printed patient chart and the audit trail:
- A clinic visit in which the patient’s need for surgery is assessed.
- Any attempt to manage symptoms with more conservative first-line measures. For example, prescription orders or referrals to physical therapy or a pain specialist.
- A diagnosis made prior to surgery and added to the patient’s problem list.
- In some cases, evaluation of the patient’s personal risk due to any comorbid conditions is done using a ‘risk calculator’ and results should be documented.
- A preoperative physical/assessment for higher risk patients.
- A complete history and physical note (H&P) within the 30 days prior to surgery.
- Procedure-specific labs and imaging which should be viewed by the surgeon prior to surgery.