Informed consent nightmares – Is it a dream that you won't have one?

Legal experts offer advice on how to avoid liability

A woman came in for breast implants and went under anesthesia. The silicone implants she had selected were not available; only saline ones were there. She was kept under anesthesia while the woman's fiance was told about the mistake and, according to the subsequent lawsuit, was pressured to make an immediate decision. He told the surgeon to go ahead with the silicone implants. The only problem? He wasn't legally authorized to make a decision for the patient.

The physician refunded $1,050 to the patient, apologized, and attempted to argue that saline implants were superior to silicone, the lawsuit says. The patient is seeking $300,000 for corrective surgery and for emotional and physical discomfort. The lawsuit accuses the surgeon of medical battery, medical malpractice, intentional infliction of emotional distress, and false imprisonment for allegedly keeping the patient unconscious longer than necessary.1 The physician did not respond to a request for comment

In another case, a physician and his facility were found liable because the doctor documented "did not get consent form, because patient doesn't speak English."2 Apparently the physician made no attempt to obtain an interpreter, which is mandatory under patient rights regulations from the Centers for Medicare and Medicaid Services (CMS), says Sue Dill Calloway, RN, Esq., BSN, MSN, JD, a nurse attorney and medical legal consultant in Columbus, OH. Calloway recently presented an audio conference on "Informed Consent 2010: The Latest in CMS and Joint Commission Consent Requirements" for AHC Media, publisher of Same-Day Surgery.

Calloway has experienced her own issues with informed consent. When she tore her anterior cruciate ligament and went in for surgery, the registration clerk handed her a consent form and said, "Here you need to sign this that the risks, benefits, likelihood of achieving the results have all been discussed." "And I looked at her and I said, 'I'm extremely embarrassed because I'm a nurse, I teach this stuff, but you know I haven't talked to the doctor about the risks and benefits and alternatives,'" Calloway says. "And being very unsympathetic she looked at me and she said, 'Look, lady, if you don't sign this, you're not having surgery today.'"

Calloway's husband and mother had woken at 4 a.m. to take her to the hospital and were waiting with her, so she signed it. "If the surveyor had come to me and said, 'Oh, how was that informed consent process?' and I just repeated what happened, they would actually cite the hospital," Calloway says. "That registration person has now violated this requirement."

The reason? Informed consent is a process, not a piece of paper, Calloway says, "and when she knew that process had not been accomplished, just saying 'sign this form or you're not having it' is violating the standards." The Joint Commission and the Centers for Medicare and Medicaid Services (CMS) are emphasizing that informed consent is a process, she says.

Don't wait for a lawsuit to be filed before you develop a thorough informed consent process, Calloway warns. When she was doing medical malpractice legal work, she had three examples of what she considered to be the best informed consent. "I found out that they had all been sued before for informed consent, and that's when they got great informed consent," Calloway says.

Consider these suggestions:

• Establish policies on intraoperative consents.

Ambulatory surgery programs should have policies about how intraoperative consents are obtained and who may grant such consent, says Patricia S. Calhoun, JD, associate at Buchanan Ingersoll & Rooney in Tampa, FL.

"Emergencies are different, but ASCs frequently run into the argument that they could have stopped and asked the patient," Calhoun says. "Because elective surgery can always be rescheduled, I think juries are less likely to understand going forward with a decision like this [different type of breast implant] from someone not authorized to grant consent in an elective surgery."

• Policies must address right to refuse treatment.

Ensure your policies and procedures address the right to request or refuse treatment, Calloway says. "...I need to know what all the risks and alternatives are so I can make an informed decision, so that's part of the informed consent process," she says.

• Have the consent on the chart before surgery.

CMS requires providers to have a consent form in the chart before patients go to surgery, except for emergencies, Calloway says. "You've got to have a policy to make sure it happens, so they should have had a process when that person knew I hadn't been given any information, that should have told her what to do," she says. The form must be signed before administration of medications/anesthetics.

If the consent form is signed outside the facility, then you have to include in your policy how you're going to get it into the chart, Calloway says. "Make this easy," she advises. "They can fax it in, they can e-mail it in, the patient can bring it with them, the doctor can bring it with him."

• Ensure thorough documentation.

From a medical malpractice perspective, the best defense is good documentation, say sources interviewed by Same-Day Surgery.

Calhoun says, "Documentation that the patient stated they had no questions, that they understood the risks and benefits, that they understood or that their physician had answered all their questions, are all helpful when the patient alleges that they did not give informed consent, because the basis of that allegation is that the patient just signed the paper."

The physician also should document the same information or even more, she says. "In addition, careful documentation any time a consent is changed in the pre-op holding room is very important," Calhoun says. "In particular, documentation about the patient's level of awareness and the timing of any medications can be key."

Anesthesia providers sometimes administer a small amount of medication for anxiety, but the exact time that medication is administered is frequently missed, she says. "Pre-op nursing can document that sedation was given per anesthesia and note the time, just in case the anesthesia provider doesn't," Calhoun says.

• Beware of electronic medical records.

Problems with electronic medical record documentation is increasing in frequency, Calhoun says.

"In order to make the charting easier and more complete, many facilities use a template," she says. "I've seen it be wonderful, but I've also found that complacency causes a template to end up with some really goofy results."

Staff might check the wrong boxes or forget to check the right boxes, Calhoun says. The end result can be a poor medical record, she says. "I'd recommend that facilities pull a sample number of the template records every quarter or so, and share the results with the staff," Calhoun says.

• Follow guidance from national organizations.

Several national organizations have developed informed consent guidance, including The American Congress of Obstetricians and Gynecologists (www.acog.org/from_home/publications/ethics/co439.pdf), the American Association of Nurse Attorneys (www.aana.com/practicedocuments.aspx), and the American College of Surgeons (www.facs.org/fellows_info/statements/stonprin.html), Calloway says.

"So whatever area you're in, always be familiar with your organization's, because if you follow those you can use them in the court room, and if you don't follow them they can be used against you," she says.

References

  1. Associated Press. Ohio woman says plastic surgeon gave her wrong breast implants. Daily News. March 15, 2010. Accessed at www.nydailynews.com/news/national.
  2. Calloway SD. Informed Consent 2010: The Latest in CMS and Joint Commission Consent Requirements. Audio conference, AHC Media. March 17, 2010.

Resources

What to include in informed consent

When performing informed consent, there are several critical elements for hospitals, including a list of the procedures that your facility has compiled that require informed consent, says Sue Dill Calloway, RN, Esq., BSN, MSN, JD, a nurse attorney and medical legal consultant in Columbus, OH. Calloway recently presented an audio conference on "Informed Consent 2010: The Latest in CMS and Joint Commission Consent Requirements" for AHC Media, publisher of Same-Day Surgery.

This list is a requirement of the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission. "You have to have a list of procedures that you do in the hospital, and you have to say 'yes' or 'no,'" Calloway says. "Make sure that all of the procedures that your physicians and your licensed independent practitioners are credentialed and privileged for are on that list."

CMS says that signed informed consent forms are needed for all hospital surgeries except in emergencies, she says. It "doesn't matter whether they're inpatients or outpatients," Calloway says.

Calloway supports individualized consent forms for each procedure, although she acknowledges that such forms take a lot of time and effort and they must be kept updated. "But I really think it's worth it, having been a defense attorney," she says.

CMS surveyors are told to confirm that the policy discusses state law and that the state law requirements are included on the consent form. They also are told to pull six medical records from the hospital. They also are told to ensure the consent forms have the minimal or mandatory elements, she says. Those elements are:

• The name of the facility. When a patient is having elective surgery and is receiving the consent form in a doctor's office, the doctor doesn't always think to put the name of the hospital on the form, Calloway says. "That's one of the two that the doctors miss," she says.

• The procedure.

• Description of the surgery, plus risks and benefits.

The description of the surgery should include the anesthesia to be used, Calloway says. You have the option of spelling out the risks, benefits, and alternatives, or simply saying on the form, "The risks and benefits and alternatives have been discussed with me," she says.

"And of course, having been a defense lawyer, I would really like to say `the risks include but are not limited to,' and that you specifically name the reasonably known risks," Calloway says.

• The practitioner.

• Who is going to perform the surgery.

The Centers for Medicare and Medicaid Services (CMS) requires that you list whoever is doing important parts of the surgery, even if the surgeon is in the OR supervising the entire time, Calloway says. Patients must be informed about staff who are assisting, such as the RN first assistant, surgical physician assistant, or surgical resident, she says. However, you aren't required to list the names of the assistants, Calloway says.

She says that one teaching hospital says in its consent form, "We are a teaching hospital, and as such we have surgical residents on most of our cases and they do help us with important parts of the surgery including helping make the decision, helping close up the incision," etc.

List all potential physicians

Be careful, Calloway warns. "If you're in a group where you cover for each other like gastroenterologists..., just say, 'Anyone in our group could be doing the procedure including A, B, and C.' Or 'Dr. A is going to be doing it, but often, the way that we're set up, any of the [doctors] can fill in, and so you have permission for Dr. B, C, and D,'" she says. If you have one doctor listed, and another doctor performs the procedure, "you don't have any informed consent," she says.

• Signature/date/time. The time is the second element that physicians often miss, Calloway says. Representatives from CMS and The Joint Commission want everything timed: "every time of every order, time of every consult report, a time of everything in the progress note," she says.

• The state law requirements.

Recommendations for surgery centers

For ambulatory surgery centers, CMS officials say that a well-designed informed consent process would most likely include a discussion of the following:

• a description of the proposed surgery, including the anesthesia to be used;

• the indications for the proposed surgery;

• treatment alternatives, including the attendant material risks and benefits;

• who will conduct the surgery and administer the anesthesia;

• whether physicians other than the operating practitioner will be performing important tasks related to the surgery. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines;

• whether, as permitted by state law, qualified medical practitioners who are not physicians will perform important parts of the surgery or administer the anesthesia, and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges.

Don't forget the implants

In addition, informed consent documentation should include details of the implant, legal sources say.

One option is to list the specific type and size of implement, such as 450 cc Mentor silicone implant, says Patricia S. Calhoun, JD, associate at Buchanan Ingersoll & Rooney in Tampa, FL.

"The physician should have already thoroughly discussed this information with the patient, but by putting it in writing, the [ambulatory surgery center] can have some additional assurance that the patient is truly informed," Calhoun says.

However, the physician might not know ahead of time exactly what size implant will be used, which would mean that the consent would have to include a list of the options or a range of possible options, she says. In addition, the facility might not have that information in advance and would have to wait for the physician to provide the information before the consent is signed, which could cause delays, Calhoun says.

"And there is the problem about what happens when the physician no longer wants to use the proposed size or style, based upon his or her surgical findings," she says. "Surgery is an art, not just a science, and decisions made based on the findings during surgery are well within the standard of care"

Managers will have to weigh the options and determine if adding that information to the consent improves their outcomes and/or the quality of care, Calhoun says.


Know your accreditation, regulatory requirements

Health care facilities, depending on their individual circumstances, might be required to follow the following group's requirements with their informed consent policies: Centers for Medicare and Medicaid Services (CMS), The Joint Commission, The Accreditation Association for Ambulatory Health Care (AAAHC), and state law.

If you are at an ambulatory surgery center that is a joint venture with the hospital, then you most likely will have to follow the CMS Conditions for Coverage, says Sue Dill Calloway, RN, Esq., BSN, MSN, JD, a nurse attorney and medical legal consultant in Columbus, OH. "And then if your hospital decides to get in a joint venture with the physicians, you decide to get it accredited by one of the ambulatory accrediting organizations, then you have to follow those guidelines," Calloway says. "So that's what makes it so confusing in this country, is that first you just have to figure out what standard applies to you." Calloway recently presented an audio conference on "Informed Consent 2010: The Latest in CMS and Joint Commission Consent Requirements" for AHC Media, publisher of Same-Day Surgery.

If you accept Medicare and Medicaid patients, then you must follow those standards for every patient, she says.

For its part, The Joint Commission defines informed consent as the "agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent." The agency says that patients must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins. After receiving this information, the patient consents to or refuses the procedure or treatment (Joint Commission Standard RI.01.03.01).

The standards don't say who should witness and sign the document, but the document clearly has to denote that there is a mutual understanding between patient and independent licensed practitioner about the care, treatment, and services the patient will receive, says Virginia McCollum, MSN, RN, associate director of the Standards Interpretation Group at The Joint Commission. However, some state laws spell out that the physician or a physician designee has to witness and sign the informed consent, McCollum adds.

For its part, AAAHC standards call for specific informed consent for the surgical procedures (10.1.T) and if anesthesia is used (9.E), according to Frank J. Chapman, MBA, chief operating officer of Asheville (NC) Gastroenterology Associates and a member of the AAAHC board.

AAAHC standards also call for informed consent for situations such as observation by non-medical staff, including medical students, and for non-medical interventions such as dental or mental health services, Chapman says.

"The process is designed to facilitate two-way communication between the patient, or the patient's legal representative, and the provider," he says.

Some providers use video presentations as part of the informed consent process, Chapman says. However, "the video is only one component of the process and cannot replace the process of open communication between the patient and the provider," he says. "In all cases there must be a formal written consent signed by the patient, or the patient's legal representative in the patient's chart prior to the procedure."

Always have the current manuals for your regulatory and accreditation requirements, Calloway emphasizes. (Editor's note: Medicare manuals are available at www.cms.gov/manuals/downloads/som107_Appendicestoc.pdf.) State hospital associations are excellent resources for requirements, as are state departments of health, she says.