By Gregory Freeman, Author


The informed consent process still creates liability risks and unnecessary costs for healthcare organizations. Physicians may not be executing informed consent in the way risk managers assume and policies require.

• Work closely with physicians to improve their consent processes.

• Research has shown a high rate of missing consent forms in surgery.

• Requirements vary across different regulatory, accreditation, and state bodies.

Obtaining patient consent is such a fundamental part of healthcare risk management that it would be easy to assume it is done consistently and properly in most cases, but that is a dangerous assumption.

Consent forms are regularly missing for many procedures and most healthcare organizations have room for improvement with this process, experts say.

A study from researchers at Johns Hopkins found that consent forms were missing for 66% of surgeries, which is especially problematic if timed antibiotics have been started. Missing consent forms delayed 10% of all surgical procedures and cost hospitals, on average, $580,000 each year, the study found. (See the story in this issue for more on the research.)

It can be surprisingly difficult to stay on top of all the informed consent requirements, says Sue Dill Calloway, RN, AD, BSN, MSN, JD, CPHRM, CCMSCP, president of Patient Safety and Healthcare Consulting and Education in Dublin, OH.

Clinicians must know which standards and guidelines apply to their situations, and often there are more than one to satisfy, she notes. Hospitals accepting Medicare and Medicaid must follow the Centers for Medicare & Medicaid Services (CMS) Hospital Conditions of Participation (CoPs), but there is a separate CoP for critical access hospitals, Calloway explains. There also are state laws on informed consent, plus requirements from accreditation organizations.

With CMS requirements for informed consent, the most frequently cited deficiencies are for Tag Numbers 131, 466, and 955, Calloway notes. The Joint Commission recently changed informed consent standards, deleting some and consolidating others, and many hospital leaders have not recognized the changes.

“How many doctors do you think know that they now need to talk about the risks of recuperation when obtaining informed consent? I bet you if I went in to a room of 100 doctors today and asked them to explain the risks and benefits of rehab after a total hip replacement, I don’t think they’d know what I’m talking about,” Calloway says. “That applies to every hospital accredited by The Joint Commission, but people are surprised when I tell them about a hospital being cited for the recuperation standard.”

Work With Physicians

Risk managers can improve consent compliance by working with physician leaders to emphasize that much of the responsibility falls on the individual doctors, and incentivizing them to improve their consent processes, Calloway suggests. She has worked with one hospital that monitored consent form compliance closely and rewarded high compliance with better OR scheduling.

Physicians should be reminded that simply obtaining a signature on a form is not enough.

“When I first became a defense attorney I wondered why people don’t get this, why informed consent is such an issue,” Calloway says. “I still think there is a disconnect between what the legal requirements are and what is actually happening.”

Calloway once was about to undergo a medical procedure when a nurse handed her a clipboard with a consent form and told her the physician would explain it when he came in. The physician entered the room, turned off the lights in preparation for the procedure, and asked if she had signed the form. Calloway said no and so he told her to sign it.

The incident opened her eyes to how the consent process can be marginalized.

“Having me sign a consent form in the dark, when no one had explained it to me, is not what any risk management professional would expect. But that is the kind of thing that happens every day,” Calloway says. “And the record afterward said he had provided informed consent, so he dictated something he never did. The hospital is not supposed to be responsible for consent unless the physician works for the hospital, but the hospital relies on the physician to obtain consent in a proper way.”

Calloway ran into the nurse soon after and mentioned the lack of informed consent, asking her if she had filed an incident report or otherwise reported it. She hadn’t.

“So the nurse knew the physician had just waltzed in and had me sign a form in the dark without obtaining informed consent, but she didn’t do anything about it. That doesn’t show that we’ve made much progress in this,” Calloway says. “Some hospitals are better than others. Those with good risk managers and counsel will do better, but they still could be surprised by what happens.”

Frequent Claim in Lawsuits

Consent issues usually are wrapped up with negligence claims in malpractice cases, rather than being a standalone cause of action, says Cynthia D. Grimes, JD, senior counsel with the Clark Hill law firm in San Antonio. Consent issues arise in up to half of all medical malpractice claims, she says, often thrown in as a standard part of asserting negligence.

“We do see plaintiffs saying they didn’t understand, and rarely they will say they didn’t sign,” Grimes says. “If people are not happy with the results of surgery they will often say they did not know that could be a consequence of the surgery. That is the responsibility of the physician and I tell them that they must be consistent with what they tell patients about specific procedures.”

Grimes explains that when physicians are consistent with the informed consent process, they can say, “I may not remember the exact conversation I had with this patient but I can testify that this is what I say in every circumstance, so I am quite confident that I told this patient about this risk.”

It also is important to have the consent document dated, witnessed, and especially to have the time noted, to show that informed consent was obtained before the administration of medications that could cloud the patient’s judgment, Grimes says. Omitting any of those factors leaves an opening for the plaintiff to contest the consent, she says.

“In addition to the consent form itself, the medical record should have a note saying the doctor came in and explained the risks and benefits, and the patient agreed to have the procedure after understanding the risks involved,” Grimes says.

“It is important that the doctor indicate he or she gave the patient information from which they could make a decision and give informed consent,” she adds. “It is not enough to say they signed a piece of paper. You need to state that you provided the information necessary for them to consider the risks and agree to the procedure.”

Older Population Needs Attention

There can be special concerns with consent in treating older patients, says Jane Carmody, DNP, MBA, RN, program officer with The John A. Hartford Foundation (JAHF), a nonprofit, nonpartisan organization in New York City that works to improve conditions for the care of older adults in the healthcare system. Particularly with end-of-life care, patients must be fully informed of options, risks, and benefits, she says, and their wishes must be respected.

That depends on good communication, which does not happen often enough with this patient population, Carmody says.

“The healthcare community is oriented to providing treatment and making people better, though what that means can differ depending on who is talking,” she says. “If you don’t have a conversation with the patient or the patient doesn’t have a family member who understands what the patient would want, you can end up providing treatment that is unwanted, unnecessary, and prolongs suffering.”

Advance directives can help avoid such situations, but they are sometimes underused.

“A lot of times the advance directive has just become a box to check off on a form, yes or no,” Carmody says. “There’s no effort to document the directive, find out where it is, and what it says. A lot of times in the rush of an acute care setting they can be hard to find and apply to the care provided.”

Carmody recommends risk managers audit conversations between physicians and patients to see what actually happens on the floor, rather than assuming a policy is being followed.

“Do the patients understand the risks and benefits, what this might mean for them in the long run? Is the health literacy taken into consideration appropriately?” she says. “Does the patient understand this might mean they will be under dependent care for the rest of their life, that they may never be able to play golf or go to church again?”

Accreditation Surveyors on Lookout

Accreditation surveyors are keen on the informed consent process, says Bernard C. McDonnell, DO, a surveyor with the Healthcare Facilities Accreditation Program (HFAP). Surveyors will look for evidence that a written informed consent is executed prior to a procedure or treatment, and information must be imparted by the provider performing the procedure or treatment prior to starting.

Specific requirements will vary among different accreditation bodies, but surveyors generally expect the consent process to begin with a conversation that is followed up by an appropriately signed and executed form per hospital/facility policy and procedures.

McDonnell says the form must include, at a minimum, these elements:

• the name of the facility at which the care is being provided;

• the name of the specific procedure or treatment for which consent is given;

• the name of the responsible practitioner — usually the physician performing the procedure;

• a description of the benefits, risks, and alternative therapies, if applicable;

• the patient’s signature or the signature of the patient’s legal representative with date and time; witnessed.

“We also like to see inclusion of other practitioners participating in the procedure under the supervision of the operating practitioner,” McDonnell says. “A separate anesthesia informed consent must be obtained by the anesthesia provider with similar content.”

The following are the most common problems McDonnell says HFAP surveyors find regarding consent:

• missing document;

• incomplete document;

• missing witness;

• missing date and/or time;

• failure to complete all necessary parts of the informed consent process.

(See the story in this issue for details on consent form deficiencies in the most recent HFAP quality report.)

“Although the physician is critical to the consent process, the document is often executed by ancillary staff,” McDonnell says. “There must be documentation that the physician spoke with the patient and provided all the information necessary for the patient to give an informed decision and consent.”

Informed consent documents should be written in the primary language of the patient and at a fourth-grade comprehension level, McDonnell says. For example, “cholecystectomy” should be written as “gallbladder removal” or “removal of a sac containing fluid that assists in the internal processing of food and nutrition.”

It is important for healthcare providers to approach consent from the point of view of the patient, McDonnel says. Patients cannot give truly informed consent if the providers have not taken the time to confirm that the patient has understood the proposed treatment, he says.

Informed consent should have the same parameters and execution across all healthcare settings, McDonnell says. But each consent is being provided by an individual patient, so the specific situation and needs of the individual should be a primary focus.

“For example, consent that is provided on behalf of a pediatric patient, or others who have a legal representative providing consent may take additional time and sensitivity in terms of finding language that meets the needs of the patient,” he says. “Psychiatric patients and psychiatric facilities have many other and different informed consents, including those for voluntary and involuntary admission.”


• Sue Dill Calloway, RN, AD, BSN, MSN, JD, CPHRM, CCMSCP, President, Patient Safety and Healthcare Consulting and Education, Dublin, OH. Phone: (614)791-1468. Email:

• Jane Carmody, Program Officer, The John A. Hartford Foundation, New York City. Phone: (212) 832-7788.

• Cynthia D. Grimes, JD, Senior Counsel, Clark Hill, San Antonio. Phone: (210) 250-6003. Email: cynthia.grimes@

• Bernard C. McDonnell, DO, Surveyor, Hospital Facilities Accreditation Program, Chicago. Phone: (312) 202-8258.