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 of the Medical Director and state or federal laws/regulations.
As the office medical director approved, see Addendum A for a list of specific care, treatments, and services that require informed consent.
This office’s informed consent process shall assure patients or their legal representatives are given the information and disclosures needed to decide whether to consent to surgery/procedures/treatments.
Informed consent must be obtained from the patient or the patient’s legal representative, by the anesthesiologist before the administration of anesthesia and by the performing practitioner before the performance of operative and 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 informed consent must be on the patient’s medical record before the 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 emergencies and may be undertaken without informed consent.
The following healthcare professionals may obtain a patient’s informed consent (as allowed under state law):
MD, DO, PA, NP ( Only contracted licensed prescribers.
2. 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 the patient’s legal representative
The likelihood of achieving goals
Potential problems related to recuperation
Choices of and to anesthesia and 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 legal guardian
The names of the anesthesiologist and performing practitioner who explained the procedure to the patient and 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:
Professional individual witnessing the patient or patient’s legal representative signing the consent form, including the date and time
Patient or representative/legal guardian (signature may be written or electronic)
If the patient cannot provide a signature, document the verbal agreement by the patient or the patient’s legal representative.
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 necessary for informed consent. Only the performing practitioner and anesthesiologist can give the information.
The informed consent form shall be:
Supplemented with verbal discussion and
Supplemented through written additions that give further relevant information
Completed and discussed with the patient and legal representative by the anesthesiologist and performing practitioner
Medical information must be written in clear, simple, and easily understood terms.
Documentation must indicate that the patient or legal guardian has had the opportunity to ask any questions they may have about the proposed anesthesia and procedure.
That the informed consent was obtained
Any limitations in the confidentiality of patient information that is discovered from or about the patient documentation by the performing practitioner in the medical record shall include:
The discussion was held with the patient
The original copy of the informed consent must be in the patient’s medical record before surgery.
Any particular 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 patient’s signature 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 a party other than the patient.
Following the same procedure, third-party consent must be obtained for an incompetent or minor patient. 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 that would affect the nature, risks, and alternatives to the procedure for which the patient gave consent.
The following is a list of specific care, treatment, and services that require informed consent:
All minor office procedures that involve using sutures, scalpels, cauterizing, or local Anastasia and any other procedure deemed to require informed consent by the treating provider using their best clinical judgment and referencing current evidence-based practice.
These procedures may include toenail removal, trigger point injections, incision and drainage, invasive wound care, wound debridement of wound, treatment of varicose veins, when in doubt as the treating provider, and preparing prefilled out general informed consent.
Black box warning medications must be documented in the clinical note every time, including the risks, benefits, who verbalized understanding, and any possible adverse reactions or side effects)
Controlled Substance Agreement Addendum A)
For all Opiate medications, see addendum B)
For all Stimulant medications, see addendum C)
For all Benzodiazepine medications, see addendum D)
Antipsychotic medications see addendum E)
General office consent all minors receiving office procedures & medications
