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Informed consent

Informed consent

Note: See state law for any additional requirements.

POLICY:

  • All patient medical records must contain a properly executed and completed written informed consent form for all procedures and treatments specified by the office Medical Director, and state or federal laws/regulations.
    • See Addendum A for a list of specific care, treatments and services that require informed consent, as approved by the office Medical Director.
  • This office’s informed consent process shall assure patients or their legal representatives are given the information and disclosures needed to make an informed decision about whether to consent to surgery/procedures/treatments.
  • Informed consent must be obtained from the patient, or the patient’s legal representative, by the anesthesiologist prior to the administration of anesthesia and by the performing practitioner prior to the performance of operative and/or invasive procedures, diagnostic or therapeutic procedures, or situations when it is deemed advisable to have formal documentation of the patient’s consent for treatment.
  • Written verification of the informed consent must be on the patient’s medical record prior to initiation of anesthesia or any of the above stated procedures, except in the case of emergency surgery.
    • The office’s medical staff shall determine which surgeries and circumstances are considered an emergency and may be undertaken without an informed consent.
  • The following healthcare professionals may obtain a patient’s informed consent (as allowed under state law):
    1. MD
    2. DO
    3. PA
    4. NP
    5. MD/DO/NP/PA Student
****** NO ONE ELSE MAY OBTAIN INFORMED CONSENT THAN THOSE WHO HOLD A PROFESSIONAL LICENSE AS ABOVE********
 
PROCEDURE:
  • A properly executed informed consent form shall contain at least the following:
    • Name of the patient and, when appropriate, the patient’s legal representative
    • Name of the office where procedure/treatment shall take place
    • Name of the specific surgery/procedure/treatment and indications for that surgery/procedure
    • Type of anesthesia
    • Name of the practitioner(s) performing the surgery(ies)/procedure(s)
    • Name of the practitioner who shall be administering the anesthesia
    • The risks, drawbacks, complications, side effects and expected benefits or effects (including the likelihood of each) of anesthesia and procedures, treatments and therapies were explained to the patient or patient’s legal representative
    • The likelihood of achieving goals
    • Potential problems related to recuperation
    • Alternative choices of and to anesthesia and/or procedures, treatments or therapies including risks, drawbacks, complications, side effects and expected benefits of alternative treatments/therapies
    • The risks, drawbacks and complications, side effects and expected benefits or effects of receiving no procedure/treatment/therapies
    • Circumstances in which information about a patient must be disclosed or reported (i.e., HIV, TB, viral meningitis)
    • The anesthesiologist’s/performing practitioner’s statement that the procedure was explained to the patient and/or legal guardian
    • The names of the anesthesiologist and/or performing practitioner who explained the procedure to the patient and/or legal representative
    • Documentation of the patient’s understanding and agreement for the care, treatment or services
    • The following signatures shall be required as part of the informed consent:
      • Patient or representative/legal guardian (signature may be written or electronic)
        • If the patient is unable to provide a signature, document the verbal agreement by the patient or patient’s legal representative.
      • Professional individual witnessing the patient or patient’s legal representative signing the consent form, including the date and time
    • Date and time consent shall be signed by the patient or the patient’s legal representative
  • Obtaining Informed Consent:
    • It shall be the responsibility of the practitioner(s) responsible for the surgery/procedure to obtain the informed consent.
    • Office staff cannot be involved in providing information that is necessary for informed consent. Only the performing practitioner and/or anesthesiologist can provide the information.
    • The informed consent form shall be:
      • Completed and discussed with the patient and/or legal representative by the anesthesiologist and/or performing practitioner
      • Supplemented with verbal discussion, and/or
      • Supplemented through written additions that give further relevant information
    • Medical information set forth needs to be written in clear, simple and easily understood terms.
    • Documentation must clearly indicate that the patient or legal guardian has had the opportunity to ask any questions he/she may have about the proposed anesthesia and/or procedure.
    • Documentation by the performing practitioner in the medical record shall include:
      • That the discussion was held with the patient
      • That the informed consent was obtained
      • Any limitations in the confidentiality of patient information that is discovered from or about the patient
    • The original copy of the informed consent must be in the patient’s medical record prior to surgery.
    • Any special circumstance(s) must be documented on the informed consent.
    • The patient shall sign where indicated and receive a copy of the informed consent form.
    • The healthcare professional witnessing the signature of the patient shall sign as a witness and document the date and time.
    • If a translator is used in the process, the translator shall sign in the area designated for party other than the patient.
    • Third party consent for an incompetent or minor patient shall be obtained following the same procedure. An informed consent for anesthesia and/or any procedure must be obtained from the third party.
  • Duration of Informed Consent:
    • Has continuing force and effect until the patient revokes the consent, or
    • Circumstances have changed which would affect the nature of, the risks of the procedure and/or the alternatives to the procedure for which the patient gave the consent.
The following is a list of specific care, treatment and services that require informed consent:
  1. All minor office procedures that involve the use of sutures, scalpels, cauterizing or the use of local Anastasia and/or any other procedure that is deemed to require informed consent by the treating provider using their best clinical judgement and referencing current evidenced base practice.
    1. These procedures may include examples such as: toenail removal, trigger point injections, incision and drainage, invasive wound care, debridement of wound, treatment of varicose veins, when in doubt as the treating provider, and prepare prefilled out general informed consent.
  2. Black box warning medications must be documented in the clinical note each and every time including the risks, benefits, who verbalized understanding and any possible adverse reactions or side effects)
  3. Controlled Substance Agreement Addendum A)
  4. All Opiate medications see addendum B)
  5. All Stimulant medications see addendum C)
  6. All Benzodiazepine medications see addendum D)
  7. Antipsychotic medications see addendum E)
  8.  General office consent all minors receiving office procedures & medications
 
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