Documentation requirements

Core Components - The Paper Trail

• The Signed Consent Form: The cornerstone of consent documentation. Must be placed in the patient's medical record before the procedure.
• Essential Elements:
  • Patient's full name & signature
  • Date & time of signature
  • Specific procedure/treatment name
  • Physician's name & signature
  • Witness signature (as per state law/hospital policy)
• Content Checklist: The form should attest that the following were discussed and understood:
  • Diagnosis or condition requiring treatment
  • Nature and purpose of the proposed procedure
  • Risks and benefits
  • Viable alternatives, including non-treatment
• Progress Note Corroboration: A physician's note in the patient's chart should summarize the consent discussion, confirming the patient's understanding and willingness to proceed.

⭐ In a life-threatening emergency where the patient is incapacitated and no surrogate is available, consent is implied (implied consent doctrine). Treatment should not be delayed to obtain documentation.

The Consent Process - Who, When, How

• Who Gives Consent?

  • Competent adults (≥18 years) or emancipated minors.
  • Incapacitated patients: Use surrogate decision-maker hierarchy (spouse → adult children → parents → siblings).
  • Minors: Consent from parents or legal guardian.

• When to Obtain Consent?

  • Before all non-emergency invasive procedures or significant treatments.
  • Must be obtained when the patient has decision-making capacity and is free from coercion or sedation.

• How to Obtain Consent?

  • A direct conversation between the physician and patient.
  • 📌 Use the BRAIN mnemonic:
    • Benefits, Risks, Alternatives, Implications of no treatment, Nature of procedure.
  • Patient must demonstrate understanding (e.g., teach-back method).

⭐ In an emergency, if a patient is unable to consent and no surrogate is available, consent is implied for necessary, life-saving treatment.

Consent Exceptions - The Grey Areas

Navigating situations where standard informed consent is not obtainable. The core principle is balancing patient autonomy with the provider's duty of beneficence.

• Emergency Exception (Implied Consent)
  • Patient lacks capacity (e.g., unconscious, delirious).
  • Requires immediate treatment to prevent serious harm or death.
  • Assumes a reasonable person would consent.
• Therapeutic Privilege
  • ⚠️ Rarely invoked & ethically controversial.
  • Provider believes full disclosure would cause severe, direct harm (e.g., profound psychological distress), preventing a rational decision.
  • Not to be used simply to avoid delivering bad news.
• Patient Waiver
  • A capacitated patient explicitly and voluntarily gives up their right to be informed. Must be clearly documented.

⭐ The emergency exception is the most frequently tested and clinically applied exception. It hinges on the immediacy of the threat and the patient's inability to consent.

High‑Yield Points - ⚡ Biggest Takeaways

• Documentation is the legal proof of the consent conversation, not the consent itself.
• It must detail the procedure, its risks, benefits, and reasonable alternatives, including no treatment.
• The patient must demonstrate understanding of the information provided.
• Must be signed and dated by the patient (or surrogate) and the provider performing the procedure.
• Consent must be obtained before any sedating medications are given.
• Emergencies are a key exception to documentation requirements.