Informed Consent 09. 2016 John Sanchez, MS, CPHRM Informed consent is both an ethical theory and a patient s right that takes into consideration a patient s needs and preferences regarding healthcare decision-making as it pertains to medical treatments or procedures that pose risk to the individual. The essential concept of informed consent is based on the belief that every competent adult has a fundamental right to self-determination i.e., to make decisions affecting one s own body and property. The American roots of self-determination can be traced to the late 1700s as a political and constitutional principle proclaimed in the Declaration of Independence: We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable rights that among these are life, liberty, and the pursuit of happiness. That to secure these rights, governments are instituted among men, deriving their just powers from the consent of the governed. The core ideology of the process of obtaining informed consent is based on the establishment of an agreement between the patient and the provider who is performing the medical treatment or procedure, resulting in the patient s authorization to undergo the medical intervention. Individuals who are unable to express this right, including minor children and incompetent or incapacitated adults, have the right to have another person represent their interests. This healthcare proxy is established to preserve the patient s decision-making right in consenting to medical treatment.
PATIENT S BILL OF RIGHTS The doctrine of informed consent is embodied within federal and state laws as well as the Patient s Bill of Rights. The American Hospital Association prepared a Patient s Bill of Rights in 1973, which was later amended in 1992. 1 Patient rights were established with the expectation that hospitals and other healthcare entities would extend these rights to patients in the interest of respecting patients wishes and autonomy in the care they receive. In 1998, the U.S. Advisory Commission on Consumer Protection and Quality established the Consumer Bill of Rights and Responsibilities. 2 This document includes several key areas one of which specifically addresses patients taking part in their treatment decisions. There are provisions within the Patient Protection and Affordable Care Act of 2010 that are now referred to as the new Patient s Bill of Rights, which addresses informed consent for patients. There are additional Bill of Rights documents that address other areas of healthcare, including mental health and hospice. These documents support a patient s right to make decisions with respect to his/her healthcare. FEDERAL STATES AND LAWS In addition to the provisions of law referred to under the Patient s Bill of Rights, healthcare entities that participate in federal funding programs overseen by the Centers for Medicare & Medicaid Services (CMS) are required to abide by the CMS Conditions of Participation. CMS has published interpretive guidelines for hospitals and surgical services that include key informed consent guidance. Interpretive guidelines applicable to hospitals include the following content: 1 American Hospital Association. Management Advisory: A Patient s Bill of Rights. Approved by the AHA Board of Trustees October 21, 1992. 2 U.S. Department of Health & Human Services, Agency for Healthcare Research and Quality. Consumer Bill of Rights & Responsibilities. http://archive.ahrq.gov/hcqual/cborr/exsumm.html. June 24, 1998.
Hospitals must utilize an informed consent process that assures patients or their representatives are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent. 3 Aging services entities may be subject to the Nursing Home Reform Act of 1987. 4 This Act was established to ensure quality of care and provides guidelines for resident rights, including informed decision-making Pertinent elements of the Act with respect to consent include: Resident s right to be fully informed in a language (s)he can understand his/her total health status, including, but not limited to, medical condition Right to choose an attending physician, to be fully informed in advance about care and treatment, and to be informed of any changes in the care that may affect the resident s well-being Right to participate in planning care and treatment or changes in care and treatment Right to refuse treatment States have established informed consent laws that address certain medical treatments and procedures and the types of information that patients must be provided so they can make informed decisions. Although state laws may differ in terminology, there are some consistencies between them. Some states adopt a professional community standard, while others focus on a patient s expectations for care. The enactment of both federal and state laws establishes a legal framework that encompasses the requirements for compliance in obtaining consent for medical care. OBTAINING INFORMED CONSENT Patient care is based on an overall plan of care centered on the patient s specific medical condition(s). When patients are admitted to a healthcare facility, it is common for them to sign a general treatment consent form that addresses many of the services they will receive during their stay. This general consent serves as the agreement with the patient for many of the services that are established in the care plan. Informed consent applies to those medical interventions that are not addressed on the general consent form; it is up to the healthcare facility, in accordance with state and federal law, to determine which medical interventions require informed consent. 3 Revisions to the Hospital Interpretive Guidelines for Informed Consent (Ref: S&C-07-17). Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/downloads/scletter07-17.pdf. April 13, 2007. 4 42 U.S. Code 1395i 3 Requirements for, and assuring quality of care in, skilled nursing facilities. Cornell University Law School. https://www.law.cornell.edu/uscode/text/42/1395i-3.
Failure to obtain appropriate consent prior to performing the associated medical treatment or procedure may subject the healthcare provider to liability for battery. 5 From a legal perspective, claims that arise from allegations of medical treatment being performed without a patient s consent are actionable under tort law. 6 Therefore, not establishing an appropriate agreement with the patient for procedures that require informed consent could subject the provider to a medical malpractice claim. There is one exception that pertains to patients in an emergency medical situation. In these instances, informed consent is not required if the healthcare entity can perform emergency services and the patient is incapacitated or unable to make decisions with respect to his/her emergency medical condition. 7 The premise for this exception is that a reasonable person would not want to be denied essential medical care when (s)he is unable to consent to the treatment. PATIENT S BILL OF RIGHTS Unfortunately, there is not a single-source document or list that outlines exactly when informed consent is required, in large part due to the differences in state laws as well as variances in the interpretation of recommendations made by professional medical groups and organizations. Because there is not a single point of reference, healthcare entities must determine which medical treatment and procedures will require informed consent. Examples of medical treatment and procedures that generally require informed consent include: Most surgical procedures Advanced or complex medical tests and procedures Radiation or chemotherapy used in the treatment of cancer Most vaccines Certain blood tests, such as HIV testing 5 J. Stanley Edwards, JD. Tort Law (Boston: Cengage Learning, 2016): 248-250. 6 Ibid. 7 Kurt M Hartman, JD and Bryan A. Liang, MD, PhD, JD. Perspectives in Legal Medicine and Health Law: Exceptions to Informed Consent in Emergency Medicine. Hospital Physician (Marzch 1999): 53-59
INFORMED CONSENT PROCESS The process of informed consent is to establish a clear understanding of the proposed medical intervention and the establishment of an agreement to proceed by the patient. This conversation with the patient occurs with the provider, with specific consent being obtained by the direct caregiver who is performing the intervention or procedure. Although a healthcare entity may have existing consent forms for specific procedures, it is still essential that the consent process occurs directly with the patient. Because patients may be receiving care and treatment for a number of different health conditions with the involvement of a number of different care providers and specialists, it is vital to ensure that clear communication occurs with the patient regarding consent. In addition to the details of the procedure and process, it is important that the patient have a clear understanding of which provider (or providers) will be performing the services as well as others who may be involved in the care process. Prior to meeting with the patient, a communication plan is established that includes several recommended goals and objectives focusing on the key aspects of informed consent. Informed consent can be obtained either verbally or in writing; however, written consent is the preferred method (in addition to documentation by the provider within the medical record). This communication plan includes such items as: The treatment or procedure, with respect to a specific medical condition and who will be involved in the procedure Benefits of the treatment or procedure, including the likelihood of achieving the goals of the patient and the plan of care Risks of the treatment or procedure, including any potential or foreseeable problems after the treatment or procedure Alternatives to the treatment or procedure and information regarding why the proposed treatment option is recommended over any alternative treatment(s) If the treatment or procedure is declined, how does this affect the patient? This includes discussions regarding consequences and how they affect the goals of the patient and the plan of care How the treatment or procedure will affect discharge planning and the patient s post-acute care If the treatment or procedure could lead to the discovery of a reportable disease or condition, this disease/condition may be reportable to local or federal entities (e.g., the Centers for Disease Control and Prevention) An important aspect of this conversation with the patient is to ensure that the information is provided in a manner that the patient understands. Healthcare providers treat a diverse population with varying degrees of capacity for understanding potentially complex medical information. There may also be language barriers that necessitate the use of an appropriate medical interpreter as part of the conversation. A best practice is to utilize certified medical interpreters and avoid the use of the patient s family members or facility staff as interpreters in informed consent discussions.
DOCUMENTING INFORMED CONSENT IN THE MEDICAL RECORD Once the informed consent discussion is completed and the provider has answered all questions and established that the patient understands the medical care to be provided, the next step is documenting the discussion and consent in the medical record. A healthcare entity will often have consent forms that are prepared in plain language for elective and non-emergent medical care and procedures. Although a signature on a prepared consent form serves as evidence that the patient has consented to a procedure or treatment, there are instances where a consent form alone may lack credibility. In professional liability claim cases, it can be argued that the patient either did not read or fully understand the form that was signed. In other instances, a patient may allege that (s)he signed the form for other reasons, including a pending loss of health insurance coverage or pressure from a family member to have the procedure performed. A strategy to support an existing consent form is for the provider who is providing the medical treatment or surgical procedure to prepare a note in the medical record that documents the informed consent discussion. This note in the medical record should capture the conversation, including the recommended content (with respect to goals and objectives listed above) and the patient s acceptance and acknowledgment of consent. It is also beneficial to include language that indicates the patient understood what was discussed. This can be as simple as adding a line to the note that affirms the patient stated (s)he understood following the patient s acknowledgment and acceptance. After an informed consent discussion, there may be occasions in which the patient does not consent to the procedure. This refusal of medically essential procedures, or care, is referred to as informed refusal. Informed refusal may be captured on a form or in the documentation of the medical record. Similar to instances in which a patient agrees and provides consent, the patient s refusal is documented along with the informed consent discussion. The doctrine of informed consent is not only an ethical obligation it is also required by state and federal law. By establishing sound informed consent processes and practices, an organization not only meets regulatory and legal compliance requirements, but it is also recognizes and respects the rights of the patient. In doing so, an organization is representing what is truly in the best interest of the patient while ensuring that a key element in the delivery of care i.e., communication is being met. Please visit Ironshore.com for the full disclaimer