Dear Director: Our hospital has told us that we need to start to get signed informed consents on all procedures, including routine procedures like bedside I&Ds and lac repair. They say it’s a Joint Commission mandate. Is that right?
Patients come to the ED, sign a consent form for treatment, and generally allow us to take care of them as we deem fit. A patient holding out their out arm for nurses to place an IV or take blood is providing implied consent. Additionally, patients sign a consent for treatment form typically during the registration process. However, the standard for consent rose as part of the 2009 CMS and Joint Commission (JC) mandate. This required hospitals to provide “culturally competent patient-centered care,” and organizations are required to “honor the patient’s right to give or withhold informed consent” by considering “patient needs and preferences” as well as legal requirements. With that said, regarding certain major therapeutic and diagnostic procedures, informed consent is required. More importantly, informed consent needs to be thought of as more than just having a patient sign a piece of paper.
High quality communication is important to patients and their families for patient centered care and informed consent gives us the opportunity to fully involve patients as part of the shared decision making process. Furthermore, the AMA states that “informed consent is a communication process between physician and patient that results in an authorization or agreement to undergo a medical intervention or procedure.” (1998) Failure to obtain informed consent can result in negligence or battery charges and could constitute malpractice. That makes perfect sense if you’re talking about a big surgical procedure where body parts might be removed, but most of what we do is fix things that are broken—lacerations, joint reductions, etc…so your question is a great one.
What’s In A Consent
Informed consent is a conversation between the doctor and the patient (and their family if they desire or their authorized medical representative) so that patients can fully participate in their care. Unless the patient is unconscious, incapable of making a decision, or harm could occur if treatment is not immediately initiated, the physician is ethically and legally obligated to present the medical facts and the therapeutic alternatives. This should be done honestly and stated simply enough for patients to understand. We also should make recommendations that are consistent with good medical practice. Physicians should disclose all medically relevant medical information to the patients. This includes discussion about the likelihood and severity of risks. And keep in mind that patient’s have the right to refuse the procedure.
Consent should be obtained by the physician performing the procedure. We know this because none of us like it when the interventional cardiologist asks us to obtain consent on a patient being rushed to the cath lab. Taking it a step in the other direction, this is not the time to ask your nurse to go consent the patient in room 19 for an LP. We need to own this discussion. The script for the consent process if fairly straight forward and should be consistent among the docs in your group. Start by discussing the diagnosis and the nature and purpose of the procedure. Then get in to the risks and benefits of the procedure and what alternatives there may be (none is an acceptable answer if that’s really the answer). The risks and benefits of the alternatives should be discussed and then finally the risks of not undergoing the procedure. At the end of this discussion, questions should be answered, the consent form should be signed and typically, consent should be documented in your note as well. Although consent can sound scary to a patient (I’m going to stick a big needle in you that might pop your lung or injure a major blood vessel) our job is to frame it in a way the patient understands and provide the true nature of the risks. The procedures that we do certainly carry real risks but our complication rates are low and this can be conveyed to the patient.
In many ways, our discussion about consent is similar to the shared decision making discussions we have with parents about doing a head CT on a child with a minor head injury. Decision making tools have been developed to aid these conversations for pediatric head injury, low risk chest pain, and thrombolytics for stoke, so perhaps the next step in our consent process would be to develop better tools that assist us with conversations regarding consent for things like blood transfusion or HIV testing (if your state requires consent). Additionally, our routine procedures should have standardized consent forms that we grab off the shelf so we’re not rushing to get a handful of things written down before we have patients sign consent.
Who Needs Consent
Like many things the JC does, guidelines are established and recommendations are made but the details are left to the hospital. For example, the JC states:
“1) The hospital’s written policy identifies the specific care, treatment, and services that require informed consent, in accordance with law and regulation. 2) The hospital’s written policy describes circumstances that would allow for exceptions to obtaining informed consent. 3) The hospital’s written policy describes the process used to obtain informed consent. 4) The hospital’s written policy describes how informed consent is documented in the patient record. Note: Documentation may be recorded in a form, in progress notes, or elsewhere in the record.”
There are opportunities to review your process. Start with your hospital’s quality department. They’re the ones who stay most up to date with the JC and CMS requirements. Also, take advantage of your mock-JC surveys. What you may not know is that there are two divisions that work within JC. The first is the one that made my hair fall out—they show up every few years to inspect the hospital. But, JC maintains an educational division as well. These people are trained just like the inspectors, but their job is to work with hospitals during these mock surveys and help us address the things that need improvement. The two divisions don’t talk so it’s a safe place to ask questions, get feedback, and improve your processes. I spent a lot of time during a mock survey discussing what’s involved with propofol for procedural sedation and the feedback was critical.
There’s a few rules to follow when determining who needs consent. Rule #1 is that you need to know what your hospital expects and follow the policy. Rule #2 is know that there are some basic things that need consent. Excluding true emergent procedures, in the ED, consent is typically needed for invasive procedures, like central lines and chest tubes, procedural sedation (any anesthesia), and blood transfusion. Rule #3 is take care of emergency procedures without consent. I’ve never met an ER doc who wouldn’t rush in to a room to intubate or cardiovert a crashing wide complex tachycardia patient with a pulse. However, once the patient is stable enough to participate in the consent process, they should be allowed. And rule #4, hospital rules and regulations can be adjusted (maybe not easily) to make it easier to do your job and provide care for low risk procedures with just a little less red tape.
You may be surprised about what does need consent in your hospital. As mentioned previously, consent is typically required for the administration of blood products and possibly HIV testing. Radiology usually gets consent for IV contrast and don’t be surprised if patients start signing consent for radiology tests because of the risk of radiation. If you’re unsure in the heat of the moment (and it’s not emergent), you’re almost always better off getting consent, and then following up with your quality department.
Who Doesn’t Need Consent
If you’re not having surgery, a major invasive procedure, a blood transfusion or anesthesia, you may not need consent. This is where the routine bedside procedures like laceration repair and I and D come into play. JC allows the hospital to determine their own policy. One policy I saw defined a procedure as anytime a needle was used in a procedure where there was a more than a minimal risk to the patient. While this may have been written to mean an arterial line, it could also imply an IM injection and that would border on the ridiculous. Since the devil can be in the details, I would suggest you look at the “consent for treatment” form that each patient signs when they come to the ED. If it’s not already in there, be sure to add a line that would include consent for simple, bedside, minimal-risk procedures. With that said, you still need to have a conversation with the patient about the procedure and the risks, make sure they’re agreeable to the procedure, and I would document this in the chart as part of the procedure note.
Much of what we do in the ER is done with the implied consent of the patient and/or the consent for treatment form patient’s sign during registration. Because the JC leaves much of the details to your hospital, be sure to know exactly what your hospital expects, and work with the quality department if you’re unsure. Communication between the physician and the patient is the key component during the process of obtaining consent. For invasive procedures and sedation, secure written consent. Consider standardizing consents for your more common procedures. Most routine bedside procedures don’t need written consent but you should still discuss the procedure, the risks and alternatives with the patient.
Look at the “consent for treatment” form that each patient signs when they come to the ED. If it’s not already in there, be sure to add a line that would include consent for simple, bedside, minimal-risk procedures. After all, if a patient comes in for a lac or a dislocated finger, we all know that fixing what’s broken is why they came to the ED.