Resident choice is a key component of person-centered care. Interpretive guidance, located in
Appendix PP of the State Operations Manual (SOM), reminds nursing homes that residents have the right to participate in decisions about their care, including whether to accept or refuse medications. Guidance on this topic is located under F552,
Right to be Informed/Make Treatment Decisions.
Surveyors continue to review how facilities obtain and document informed consent. Now is a good time for providers to review their processes and ensure staff understand their responsibilities.
Why Informed Consent Matters
Residents have the right to be informed of, and participate in, their treatment. Additionally, the resident has the right to be informed in advance by the physician, practitioner, or other health care professional of the risks and benefits of proposed care and treatment, available alternatives, and treatment options, and to choose the preferred option. Before a medication is started or significantly changed, residents, or their legally authorized representatives should receive enough information to understand the treatment and make an informed choice.
Facilities should demonstrate that informed consent discussions occurred and that the resident's decision was respected and documented.
What Should Be Included in an Informed Consent Discussion?
An informed consent discussion should include:
- Why the medication is being prescribed.
- Expected benefits of the medication.
- Potential risks and side effects.
- Alternative treatment options, when appropriate.
- The resident's right to refuse treatment.
- What may happen if the medication is declined.
The discussion should be presented in a way that the resident or representative can understand and should allow time for questions. The resident has the right to be fully informed in a language that he or she can understand.
Documentation Is Critical
If informed consent is not documented, surveyors may determine it did not occur. Facilities should ensure documentation includes:
- That an informed consent discussion took place, and who was included in the discussion.
- Information provided about risks, benefits, and alternatives.
- The resident's or representative's decision.
- Follow-up discussions when medications are started, changed, or discontinued.
Documentation should be consistent throughout the medical record and care plan.
Consider Psychotropic Medications Carefully
Psychotropic medications continue to receive significant attention. Facilities should ensure informed consent is obtained and documented when these medications are initiated or when significant changes are made to the regimen, such as an increase in doses.
Providers should also consider and document non-pharmacological approaches when appropriate and ensure residents understand their treatment options. Document what was attempted, what worked, what did not work, and if there are clinical contraindications.
Staff Education Remains Essential
All members of the interdisciplinary team should understand the facility's informed consent process. Staff education should address:
- When informed, consent is required.
- Who can provide consent.
- Documentation expectations.
- How to address medication refusals.
- Any state-specific requirements.
Regular training and audits can help identify and address potential compliance issues.
Key Takeaways
- Review your facility's informed consent policies and procedures.
- Ensure residents and representatives receive information about medication risks, benefits, and alternatives.
- Document informed consent discussions and decisions clearly in the medical record.
- Educate staff on their roles and responsibilities.
- Periodically audit practices to ensure compliance.
Strong informed consent practices support resident rights, promote person-centered care, and help facilities remain survey ready.