by Linda Ramsey, assistant vice president, Risk Management

You had the discussion, scheduled the procedure, written a thorough note in the patient’s chart and asked the patient to sign the consent form. When you get the consent form back, the patient has crossed out or written over parts of it. Can you proceed? Should you proceed? What do you need to consider? Addressing the dilemma is the topic we will discuss in this month’s Risk Management CME article.

The consent form conveys two types of information to a patient; clinical – what will be done and the risks, and procedural – taking photos, tissue disposal, release of information to the FDA for certain implants, etc. You must determine what type of information is being changed, and if you can safely, or reasonable agree, with the changes.

The patient cannot dictate how clinical care should be performed, or the manner in which it will be provided. The patient can request certain allowances which you may be able to honor. When faced with changes to the consent form, you must make it clear to the patient if you will or will not accept their requests, and also document this discussion. A consent form altered by the patient without any corresponding documentation by you can be argued to represent your agreement with the changes made.

If the patient seeks to change a portion of the form related to clinical care, and in the physician’s clinical opinion it would not compromise patient care, you and the patient may come to a mutual agreement.  For example, a patient may request a different form of anesthesia that is clinically appropriate. The patient’s request must be clinically supportable for your agreement to meet the standard of care.

Many patient requests for a clinical action – “I only want surgical glue used” or prohibit certain treatment – “I do not want forceps or a vacuum used, do a c-section instead,” may impair your ability to render care that is clinically indicated to the detriment of the patient.  If the physician does not believe that the patient’s request is in his/her best interest, and the patient persists in his/her request, the physician can advise the patient that he/she can not perform the procedure given the limitations the patient is imposing. The physician must document any conversation he/she has with the patient regarding modification or changes to the consent form in the medical record, and share those changes with the hospital.

Patients may also request changes to how care is provided. Specifically, they may request that residents not treat them or assist with surgery. Crozer-Keystone hospitals are teaching facilities and support medical learning and growth. Though we may attempt to honor our patients’ requests, there may be situations in our teaching hospitals when this request can not be honored. Physicians must make their patients aware of this prior to procedure or treatment. 

In addition, patients may also want to stipulate on their consent forms that they do not want to be cared for by a physician or nurse of a specific gender or ethnic background.  As stated in our policy, Crozer-Keystone hospitals will not honor requests for discriminatory preferences in caregivers. Though we are aware that there are certain circumstances in which we will try to honor requests for gender preferences in certain patient care services, (i.e. bathing), patients must be told that circumstances may not permit this and all of staff are trained to perform their care responsibilities.

If a patient requests a change that involves the provision of care at the hospital, a hospital representative must agree to the change.

“Consent” is the process act of discussing a specific diagnostic test or treatment; it is not merely the completion of a form.  It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention. It is a “meeting of the minds” regarding what is and is not to be done. This meeting of the minds prevents confusion and anger later.

Informed consent is a three-part process.  The first part is the disclosure and explanation to the patient, the nature of a proposed procedure or treatment, its potential risks and benefits, and reasonable alternatives, which may be available.  The second part ensures that the patient understands what has been explained to him or her.  Finally, the process, like all care activities, must be documented.