One of our colleagues, Andrew Michaels, MD, Director of the Cardiac Catheterization Laboratory at St. Joseph Hospital in Eureka, California, recently asked about the consent process for cardiac cath cases. “Does the operating cardiologist need to be the one who performs the consent process with the patient, or is it acceptable to have another cardiologist perform the consent process for inpatients? Our hospital policy states that the ‘treating physician is responsible’ for the consent process. We have had consulting cardiologists do the consent process with the patient, and sometimes a different cardiologist may end up doing the procedure. Is it required to have the performing cardiologist repeat the consent process? For teaching hospitals, does the performing fellow need to be the one perform the consent process? I wanted to see what your thoughts are on this.”
Several members of our expert cath lab group shared their thoughts about getting consent in their labs and while I’m not an attorney (duh), I did some research on the internet to enlighten and remind us of what’s required for an accurate and complete patient consent for a medical procedure (see below).
My thoughts are that the consent policy is part of the local hospital’s bylaws and policies. At teaching institutions and perhaps other hospitals with physician extenders, consent can be obtained by the cardiovascular fellow or a trained physician extender (nurse practitioner [NP] or physician assistant [PA]) working under the supervision of the operating physician. In the outpatient cardiology clinic, I or my fellow obtain consent for a planned cardiac cath that will be done by one of my other partners, since I am only doing procedures at the VA lab. The consent includes the operators’ name(s) on the consent form. For such a “surrogate” consent, I believe the operating physician must speak again with the patient and family before the procedure to be sure they understand the risks and benefits, and their questions are answered. Where the conversation and consent is obtained is also important. In our lab, after the fellow has consented the patient, I will speak with the patient and family in the holding area. In some cases, I review the procedure with the patient in the lab again before the time-out and before the pre-medication is given. [Reminder: Once the patient has received pre-medications, additional consent will not be valid.]
Local policy dictates the rules of consent in that hospital. Some hospitals require a physician credentialed to do the procedure or a “fellow designee”. It cannot be an advanced practitioner. However, many feel that an advanced practitioner, who has nothing to gain by doing a cath or percutaneous coronary intervention (PCI), could provide a more unbiased and informed consent, and could do it in clinic so that the patient is consented well ahead of time. Not all hospitals agree.
Another problem is the consent for a procedure that is performed by a diagnostic invasive cardiologist and then handed off to an interventionalist for ad hoc PCI. It is hoped that the patient’s new operator will be added to the consent, or better yet, be part of the initial consent process. Consent for the diagnostic and possible ad hoc PCI should include the PCI operator (if known) before going forward with the PCI. When I was working in this setting as an interventionalist stepping in to do ad hoc PCI, I would always review everything, speak to the patient, go out and speak to the family, write a note, then scrub and do the PCI. Consent for cath and PCI was obtained by the diagnostic physician, but without specifying a PCI operator. It was not ideal. I believe there is a large variation of practice around the consent process. Let’s see what our experts say…
Jim Blankenship, The Geisinger Clinic, Harrisburg, Pennsylvania: A recent issue involved informed consent information provided by an advanced practitioner. Because of a consent problem, our system CMO (an MD JD) now requires that informed consent be obtained by a physician credentialed to do the procedures. It does not have to be the doctor that actually does the procedure, just a doctor credentialed to do it. Trainees and advanced practitioners are prohibited from saying anything about informed consent unless the attending is physically present.
Jeff Moses, Columbia University, New York City, New York: That’s not the way it is in NYC. Consent is performed according to hospital bylaws. We just had that affirmed with a PA getting consent, which was upheld on appeal. It is our standard at Columbia University as well. Certainly any MD obtaining consent as a surrogate should be secure.
Lloyd Klein, Rush University, Chicago, Illinois: We have a similar process to Jim. I have been told that the law in Illinois is that a physician must obtain the consent, and that this is interpreted by hospitals as reported above. I don’t have the specific information that this approach is predicated on case law, but the hospital attorneys are the drivers for this.
We should recall that there are 3 aspects to informed consent that are part of the legal doctrine: capacity to give consent, disclosure of adequate information to make a decision, and voluntariness — the patient doesn’t have to have the procedure. The issue as to who obtains consent relates back to disclosure — if the doctor performing the procedure didn’t obtain the consent, or it wasn’t obtained by a certified physician at all, then legally the process can be challenged that insufficient information was given to the patient to make an informed decision.
Charles Chambers, Pennsylvania State University, Harrisburg, Pennsylvania: It [the operating physician getting the consent] is “law” in Pennsylvania. I was told a patient had a surgical procedure by a surgeon who never saw the patient or family pre-operatively, with no input into informed consent, resulting in a major issue when significant complications occurred. This issue quickly escalated and produced a statewide mandate that only the attending/operating physician is to obtain consent for all invasive procedures. Since July 2017, when this mandate came from the state superior court, our hospital lawyers and administrators told us that no patient is allowed on the table until the attending has obtained the signed informed consent.
As informed consent is an ACGME (Accreditation Council for Graduate Medical Education)-mandated required skill for fellows, physicians-in-training as well as PA/NPs must be able to discuss the necessary components of a procedure during the pre-cath history and physical process. Then, the attending physician, assuming full responsibility for the informed consent process, continues discussion as appropriate, answers questions, and obtains the signed consent.
Definition of Informed Consent
Following is some of the information I learned to better understand what is expected of us when obtaining patient consent for a medical procedure.
The specific definition of informed consent may vary from state to state. Informed consent means that a physician (or other medical provider) must tell a patient all of the potential benefits, risks, and alternatives involved in any medical procedure, other specific course of treatment (like chemotherapy) or research, and must obtain the patient’s written permission to proceed (Table 1). The concept is based on the principle that a physician has a duty to disclose information to the patient so he or she can make a reasonable decision regarding treatment. The informed consent process arose from the Nuremberg Trials after WWII, where the atrocities of Nazi medical experimentation on unwilling subjects came to light. Following the trials, the Nuremberg Code was drafted, which emphasized the need for consent in any human medical experimentation and was extended to any medical procedure that was associated with risk to the patient.
The Role of the Physician
Physicians themselves, rather than a representative, nurse, or other related health care professional, are the best person to speak to the patient about the procedure that is planned and obtain informed consent. In discussing the procedure, risks, and benefits with the patient (and always, if possible, with the family), the physician should cover the following important points:
- The diagnosis (if it is known).
- The nature and purpose of the proposed procedure(s) and associated treatments that may accompany the main procedure (e.g., intra-aortic balloon pump [IABP], pacemaker if needed).
- The benefits and the risks of the proposed procedure.
- The alternatives to the proposed procedure. The alternatives should be discussed regardless of their cost. Discussions regarding whether the patient’s insurance will cover the procedure should be had before entering into the discussion of the consent for the specific procedure and are often not appropriate coming from the physician.
- The risks and benefits of alternative treatments or procedures.
- The risks and benefits of not receiving or undergoing any treatment or procedure.
In explaining the procedure and associated treatments to the patient and family, it is important to explain at the level of understanding of the patient. Use of complex medical language is a disservice to the patient. A level of medical literacy should not be expected even of an educated, medically knowledge patient, since the anxiety and concern about undergoing the procedure often interferes with the ability of the patient to hear and understand what is being told to them. A physician should ensure that patients understand what they are hearing. I recommend to our fellows to explain things as if they were 4th graders and go up from there as you understand the patient’s comprehension level.
The signature should come from the patient or the patient’s authorized representative. The physician and patient both sign and date the consent documents. The patient or the authorized representative must be given a copy of the signed documents and a copy is then kept in the patient’s chart (Table 2).
The Role of the Patient
It is worth recalling that patients also play a part in the informed consent process. While a physician is required to inform a patient about benefits, risks, and alternative treatments, patients must listen to the physician and ask questions if they do not understand or if they would like more detailed information. Recall that anxiety, stress, and poor medical literacy may impair the patient’s comprehension. Using a “teach-back” review is often worthwhile. For example, “Mr. Smith, I’ve just explained the procedure and risks. Can you tell me what we’re going to do and any of the risks?” Often a second, hopefully briefer, re-explanation will be helpful.
Which Procedures Require Informed Consent?
Unfortunately, there is no list describing exactly what procedures do and do not need informed consent. Procedures requiring consent are subject to clinician or hospital interpretation of recommendations from professional and specialty medical societies or groups. Participation in any medical trials or experiments, whether they have federal funding or not, means informed consent must be obtained from any human participant or subject.
How Much Information Needs to be Disclosed?
Another aspect of informed consent subject to local interpretation is exactly how much information must be disclosed. How many potential risks must be described verbally or written on the consent form? How many alternatives must be mentioned? Many states rely on a standard of what a “reasonable physician” would provide or what a “reasonable patient” would need, which still leaves room for interpretation. Most laws describe the need to cover all “material” (i.e., significant) risks. But common sense suggests that not every potential risk can be described in detail, and that only the most prevalent and/or serious risks and side effects should be covered. In addition, the number and type of complications also may vary widely, depending on the severity of the patient’s underlying conditions or comorbidities (e.g., pneumothorax following central vein catheterization may not be life-threatening in a cath lab patient, but could be in a patient on mechanical ventilation for respiratory distress). Further complicating the issue, of course, are the limitations and variations in the capacity of individual patients to comprehend many of these details. Therefore, the information needs to be tailored to each individual.1
In emergency situations, it may not be possible to speak to the patient to obtain consent (the patient is unconscious or unable to communicate) or because of a critical clinical problem with potential for loss of life or limb, there may not be time to obtain a patient’s informed consent. In this setting, many hospitals permit a 2-physician rule with both physicians verifying the procedure’s necessity, reporting to the hospital administrator on duty, and proceeding with the life-saving intervention.
The Bottom Line
Local hospital policy dictates who can obtain consent for the procedure and what procedures need informed consent. It behooves us all to be sure the patient and family understand the procedure, its risks, and benefits. Explaining in simple, clear language and repetition will go a long way to an informed and satisfied patient, meeting our ethical, professional, and clinical obligations. For more detail, I suggest you speak directly with your hospital’s risk management team.
- Informed consent: More than getting a signature. The Joint Commission. Available online as a pdf download at: https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdf. Accessed February 12, 2018.
Disclosure: Dr. Kern is a consultant for Abiomed, Merit Medical, Abbott Vascular, Philips Volcano, ACIST Medical, Opsens Inc., and Heartflow Inc.