Author: Elizabeth Salvia
Informed consent is a critical aspect of healthcare that goes beyond a mere signed document. It's a dynamic conversation between healthcare providers and patients, ensuring that patients are fully aware of their treatment options, risks, alternatives and benefits.
The Centers for Medicare & Medicaid Services (CMS) recently updated requirements for informed consent related to sensitive exams (including breast, pelvic, prostate and rectal examinations) conducted for the purposes of training and education. It's important to understand these new regulatory changes and how they may affect healthcare organizations' policies and procedures concerning informed consent
The holistic approach to informed consent
Informed consent is a patient-centered, educational process that considers the patient's individual needs and preferences.
By engaging in open and transparent discussions about proposed treatment options, healthcare providers can empower patients, or their legally authorized representative, to make informed decisions. This collaborative approach aligns with the laws and regulations governing informed consent and fosters a patient-centric healthcare environment.
According to CMS Conditions of Participation, a properly executed informed consent document includes the following minimum elements: 1
- Healthcare facility name where the procedure is taking place
- Procedure or treatment name
- Responsible practitioner's name
- Explanation of a procedure or treatment, including benefits, risks and alternatives
- Patient's or legal representative's signature
- Date and time of signature
Furthermore, it's imperative to include state-specific laws in the consent documents and policies of each facility. Regardless of whether the forms are electronic or paper, it's crucial to ensure that all completed consent forms are documented and included as part of the patient's medical record.
For invasive procedures and operations, informed consent is always required. Generally, the only exception would be if emergency treatment is required to save the patient's life or limb and obtaining informed consent is not reasonably possible under emergency circumstances. In these emergencies, consent is implied.
Regarding minors and adults who lack capacity (per federal and state-specific laws and definitions), it's imperative to exercise due diligence to identify the suitable legally authorized representative when seeking consent. All relevant documentation, such as court orders or other pertinent records (e.g., power of attorney, court-appointed legal guardianship, adoption decrees, etc.), must be documented in and included as part of the patient's medical record.
Consent for sensitive exams
Recent media attention and growing concerns within the medical community have brought the long-standing practice of performing sensitive exams on anesthetized patients for the purposes of training and education to the forefront. Patients who've undergone these examinations without their consent have publicly spoken out about their experience, shedding light on the need for proper consent procedures. These individuals have courageously spoken out about the distress and emotional trauma they've endured as a result.
Their stories have resonated deeply within the medical community and have sparked a necessary conversation about the importance of respecting patient autonomy and ensuring that patient rights are upheld, even in the context of medical training and education.
To tackle these mounting concerns, several states have taken proactive measures by implementing laws that mandate informed consent for sensitive exams conducted for training and education purposes.2 These laws aim to ensure that patients are fully aware of and agree to the procedures and examinations being performed on them, granting them a sense of control and protection. Simultaneously, these laws also empower healthcare providers by establishing clear guidelines and expectations for obtaining consent.
However, it's important to note that despite these positive developments, many states still lack legislation specifically addressing the issue of informed consent for sensitive exams. This gap in legal protection leaves both patients and providers vulnerable to potential ethical and legal challenges.
New CMS regulations
As of April 1, 2024, CMS updated the informed consent interpretive guidance within the State Operations Manual.1 These revisions now explicitly outline the requirements for obtaining written documentation of consent for sensitive exams conducted for "training and education."
One of the key changes is the introduction of mandatory written informed consent for medically unnecessary, sensitive exams performed on patients who are undergoing unrelated procedures with anesthesia. This change means that healthcare providers are now required to obtain written consent from patients before conducting any sensitive exams for training and education that are performed alongside other medically necessary procedures requiring anesthesia. Additionally, patients who are undergoing procedures that don't require anesthesia must provide their verbal consent prior to a sensitive exam for training and education purposes.
For healthcare organizations and providers operating in states without prior laws mandating written informed consent for these exams, it's critical to carefully review and incorporate these new regulations into their policies and procedures. The implementation of these revised requirements aims to ensure that patients' rights and autonomy are protected.
Also, it's essential for healthcare providers and trainees to be educated about these changes to guarantee compliance with the new regulations. By doing so, healthcare organizations and providers can uphold the highest standards of patient care and maintain the trust and confidence of their patients.
Sexual misconduct claims
Informed consent is a fundamental aspect of patient-centered care. When done effectively, informed consent can help establish trust, prevent misunderstandings and reduce the risk of sexual misconduct claims related to sensitive exams and procedures.
Incorporating policies that clearly outline the facility's stance on training and education related to sensitive exams and how to appropriately obtain consent is imperative.
Additional risk reduction strategies for sexual misconduct claims involving sensitive examinations may include:
- Provide patients with information about their rights, including their right to a safe and respectful environment and how to report any concerns or complaints.
- Use plain language and ensure that conversations, consent forms and other documents provided to patients are easily understandable, providing translations and interpreters for patients with limited English proficiency.
- Establish and enforce a chaperone policy that mandates the presence of a trained healthcare professional during sensitive exams or procedures.
- Develop a comprehensive reporting system that allows patients, staff members and visitors to easily report any concerns or complaints, ensuring that the reporting process is confidential, accessible and free from retaliation.
- Regularly review and audit compliance with policies and procedures related to informed consent, sensitive exams and chaperones.
- Investigate all reported concerns or incidents promptly and thoroughly, taking appropriate action when necessary.
For additional questions or support, the National Risk Control team at Gallagher is at your service, offering expert consultation in navigating best practices for informed consent.
