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“What We’ve Got Here is a Failure to Communicate.”

Larke A. Nunn LHRM, CPHRM

Introduction Besides being one of the most recognized movie lines of all time, it is a perennial truth for physicians and their patients. The gap between patient expectations and health care system delivery still exists despite ongoing risk management efforts. Lack of informed consent remains the most common secondary allegation in malpractice claims involving physicians. Advanced technology and pharmaceutical advertising make it increasingly difficult to manage patient expectations about potential treatment outcomes. Compounding the problem is the fact that case law is constantly evolving in today’s liability climate. That necessitates performance improvement in virtually every aspect of health care, including the informed consent process. Patients want to know the truth. Studies show that patients have always wanted to know the truth and be involved in their own care. Patients want to make their own decisions and have a full understanding of what is being recommended. The more severe and likely the potential complications, the more they want to know about them. Florida Patient’s Bill of Rights and Responsibilities, §381.026, Florida Statutes, states: “A patient has the right to be given by his or her health care provider information concerning diagnosis, planned course of treatment, alternatives, risks, and prognosis, unless it is medically inadvisable or impossible to give this information to the patient, in which case the information must be given to the patient’s guardian or a person designated as the patient’s representative.” A process, not just a form In today’s litigious environment, one should understand that informed consent is the process wherein the physician preoperatively provides the patient with all of the information needed to make a knowledgeable (informed) decision about the recommended care. Proper informed consent also presumes that the patient has an opportunity to have all questions answered to full satisfaction by the physician prior to signing the consent form. Federal law 42CFR482.51 (b)(2), Condition of Participation: Surgical services, requires “A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies.” The purpose of the form is to help the physician document the process – what information was shared with the patient in the discussion – and to provide a rebuttable presumption that the consent was valid. In the event the patient experiences a complication and files a subsequent malpractice claim, the burden of proof rests with the plaintiff. The Florida Medical Consent Law, §766.103, Florida Statutes, defines informed consent as including three basic elements: “A reasonable individual…would have a general understanding of the procedure, the medically acceptable alternative procedures or treatments, and the substantial risks and hazards inherent in the proposed treatment or procedures….” Does this mean we have to tell the patient about every possible thing that could happen? No, the patient only needs to know about those risks the physician considers significant. What makes a risk significant? Based upon case law interpretation to date, significant risk is one that occurs often enough to be considered “known and recognized.” Or, although occurring infrequently, it is of a serious enough nature to be considered significant, such as stroke, heart attack, or death. Non-delegable physician duty obtaining consent is a physician duty (allopathic physician, osteopathic physician, chiropractic physician, podiatric physician, and dentist). Florida law is devoid of any mention that someone other than these individuals may be designated to obtain consent. Florida Statutes, §458.331(1)(w), states that delegating professional tasks to an individual who the professional “…knows or has reason to know that such person is not qualified by training, experience, or licensure to perform…” is grounds for disciplinary action by the state board. This is not to imply that nurses and physician extenders cannot assist in the process by having the form signed by the patient so long as that individual has first confirmed with the patient that the physician has in fact spoken with the patient and that the patient has no remaining questions. If the physician has not spoken to the patient or if the patient has additional questions, then the physician must be summoned to speak with the patient before proceeding any further. Florida Administrative Code 64B8-9.007, Standards of Practice, (1) states that the ultimate responsibility for diagnosing medical and surgical problems rests with the physician who is to perform the procedure. Additionally, it assigns responsibility to the surgeon or the physician’s designee (another attending or resident) to explain the procedure to and obtain the informed consent of the patient. The most cited example in case law is Cedars Medical Center v. Ravelo (3rd DCA 1999) wherein a patient in her late 20s sued the hospital and a general surgeon, alleging medical negligence during an exploratory laparotomy in which an abdominal mass and certain affected organs were removed. The patient signed a consent form that was provided and witnessed by the prepping nurse. During the course of exploration, the surgeon encountered an ovarian mass as well as an unanticipated large amount of blood and adhesive tissue that required draining and lysis. An OB/GYN intra-operative consult was obtained and the two physicians agreed it was necessary to remove the ovaries, the fallopian tubes, and the uterus. The jury found that the surgeon did not fall below the standard of care in his treatment of the patient. However, they returned a $2 million joint verdict against the surgeon and the hospital based on negligence for not obtaining the patient’s informed consent to remove all of her reproductive organs. The case was subsequently appealed by the hospital which argued that as a matter of law, it had no duty to obtain the patient’s informed consent for procedures performed by the surgeon. The appeals court ruled that Florida law confines liability for a failure to obtain informed consent to the physician, not the hospital. Process elements The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), under the “Patient Rights and Organizational Ethics” chapter, requires that patients be involved in decisions about care, treatment, and services provided and that informed consent be obtained. The informed consent discussion must include the nature of the proposed care; potential benefits, risks or side effects, including potential problems related to recuperation; the likelihood of success; reasonable alternatives to the proposed care; the relevant risks, benefits, and side effects related to the alternatives, including possible results of non-treatment; and, when indicated, any limitations on the confidentiality of information learned from or about the patient (RI.2.30. RI.2.40). RI.2.70 states that patients have the right to refuse care, treatment, and services in accordance with law and regulation. The patient should also be informed as to:

• The name of the physician or other practitioner primarily responsible for his/her care;

• The identity and professional status of the individuals responsible for authorizing and performing the procedures and treatments;

• Any professional relationship to another healthcare provider or institution that might suggest a conflict of interest;

• Any relationship to educational institutions involved in the patient’s care; and

• Any business relationship between individuals treating the patient or between the organization and any other health care, service, or educational institutions involved in the patient’s care (RI.2.60).

The interpretative guidelines for 42CFR482.51(b)(2), COP, lists the following additional information as being included in a “properly executed informed consent”

• Date/time consent obtained.

• Statement that the procedure was explained to patient.

• Signatures of person providing consent and witness thereof.

• Name of hospital.

• Name of physician(s) performing the procedure(s) or important aspects of the procedure(s).

• Names and the specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon or other physician.

Significant tasks include opening; closing; harvesting grafts; dissecting, removing, or altering tissue; and implanting devices. Documentation relative to these items is often included in other areas of the patient’s chart rather than on the consent form. Mandatory reporting The Florida Internal Risk Management Program, §395.0197, Florida Statutes, requires that a report (Code 15) be filed with the Agency for Health Care Administration (AHCA) when a complication not specifically addressed in the documented informed consent for a surgical procedure occurs and requires surgical repair. If a patient requires specialized medical attention or surgical intervention resulting from a complication from a planned medical intervention (interpreted as any form of treatment) that was not addressed in the documented informed consent, then it must be reported to AHCA on the facility’s annual report of incidents. AHCA shares information with the Florida Department of Health, which, if the information is legally sufficient, conducts its own investigation to determine if licensees such as a physician or nurse violated their individual practice act. Nurses can be investigated to determine whether or not they followed the hospital’s policies related to making sure all the required paperwork was present and appropriate before the procedure was performed. Physicians can be investigated for not obtaining complete informed consent. At the conclusion of the Department’s investigation, the probable cause panel of the applicable board determines if probable cause exists to initiate a disciplinary action against the health care provider. If the panel finds probable cause and directs the initiation of a disciplinary action, ten days thereafter the entire investigative file of the Department becomes public record and a plaintiff’s attorney can obtain the file. Disciplinary actions can result in penalties such as a letter of concern or reprimand, monetary fine and payment of costs, additional training requirement, community service, suspension, and revocation of a license. Conclusion and resources The consent process is the physician’s opportunity to build rapport and establish clear lines of communication with the patient. If the patient likes the physician, the patient is less likely to litigate. If the physician does not take the time to talk and listen to the patient and there is a bad outcome, it is more likely that the patient will hire a lawyer and complain to a regulatory agency. With properly documented informed consent, a malpractice lawsuit or board investigation can be defended. The Shands Intranet contains links to the applicable laws and regulations as well as the available forms. The consent form template has blank areas to capture data for each of the elements required by the medical consent law. The form has been approved by the appropriate committees for “stand alone” use, with the information written in, or as a template to create customized forms for specific procedures. It is highly recommended that each department develop customized forms for procedures that are performed often, that are complex, or that subject the patient to significant risk (frequency/severity). For educational presentations on this or other topics or assistance in developing customized consent forms, contact the UF Self-Insurance Program, Risk Management and Loss Prevention at (352) 273-7006 for Gainesville or (904) 244-3568 for Jacksonville. Should informed consent questions arise during the provision of care, please contact Shands Legal for assistance at (352) 265-8051 for Gainesville or (904) 244-2861 for Jacksonville. References 1. Medical Risk Management Advisor, “Informed Consent Update,” Volume 13, Number 1, 1st Quarter 2005, pp 1-2. 2. Dodge, A. When Good Doctors Get Sued, www.dodgeconsulting.com. 3. Scott, R. Legal Aspects of Documenting Patient Care, Aspen Publishers, Inc., 1994. 4. Colon, V. Medical Malpractice Risk Management, American College of Physicians’ Publications, 2001. 5. Pozgar, G. Legal Aspects of Health Care Administration, 7th Edition, 1999. 6. 2004 Florida Statutes, Chapters 380, 395, 458, 766. 7. 2004 Florida Administrative Code, Chapter 64. 8. 2005 U.S. Federal Register, Title 42, Chapter IV. 9. State of Florida Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretative Guidelines for Hospitals, Revision 1, 5/21/04. 10. Hospital Accreditation Standards, Joint Commission on Accreditation of Health Care Organizations, 2005.