Page 1 of 5 POLICY/PURPOSE: The purpose of this policy is to ensure proper documentation of the right of patients and patient s legal representatives to make informed decisions regarding medical care. Iowa law places the responsibility for obtaining informed consent on the practitioner performing the procedure. Each practitioner shall determine which procedures are associated with significant risk or complication and for which informed consent must be obtained. DEFINITIONS: Practitioner the licensed independent practitioner (LIP) performing the procedure being consented. This may include physicians, podiatrists, or dentists or other LIP granted privileges by the Board of Trustees. Emancipated Minor As a general rule, minor patients (age 17 or younger) may not consent to treatment except for minors who are: married, financially independent and have received a judicial decree of emancipation, seeking medical services for: the prevention, diagnosis, or treatment of sexually transmitted diseases or other reportable infectious disease, pregnancy, or seeking treatment for abuse of controlled substance or alcohol, or emotional disturbance. PROCEDURE: 1. The responsibility for obtaining a patient's informed consent is that of the practitioner who will perform the procedure or a practitioner associate. Emergency situations or situations in which the disclosure of information poses a threat to the safety and well-being of the patient are exceptions to the need to obtain informed consent. Informed consent includes material risks and benefits of the procedure/treatment and the risk and benefits of treatment alternatives. 2. Informed consent shall be obtained and documented for the following non-exhaustive list of categories of procedures. Informed consent may also be obtained for procedures not on this list. Procedures requiring informed consent include, but are not limited to: Any procedure performed under general, spinal, or epidural anesthesia Procedures that involve penetration of the skin i. Note: Routine procedures not included in this category include: drawing blood and establishing peripheral access. Procedures that enter a body cavity, including, but not limited to: lumbar puncture, bone marrow biopsy, paracentesis, laparoscopy, thoracentesis, pericardiocentesis, tracheostomy, bronchoscopy, and chest tube placement i. Note: Routine procedures not included in this category include: routine urinary catheter placement, arthrocentesis, joint, tendon, sheath and bursa injections, and nasogastric tubes. Procedures with potential for perforation into a body cavity, including, but not limited to: endoscopic procedures
Page 2 of 5 Major therapeutic and diagnostic interventions and procedures with known material risks, including, but not limited to: organ biopsy, bone marrow transplantation, laser therapy, brachytherapy, lithotripsy (gall bladder, biliary tree, kidney stone), cardiac catheterization, central arterial lines, and central venous lines Diagnostic or therapeutic procedures that include administration of diagnostic agents with risk of significant reaction, including, but not limited to: angiography, myelography, and hysterosalpingography i. Note: Routine procedures not included in this category include: contrast gastrointestinal studies, intravenous pyelography, computerize tomography, and magnetic resonance imaging and radiotracer studies. 3. Under no circumstances are hospital personnel responsible for discussing risks, benefits, and alternatives for any procedure. Hospital personnel may write the procedure name on a printed consent form only if it has been provided in writing in the medical record. o If the name of the procedure specified on the consent form differs from the procedure specified in the medical record or on the surgery schedule, clarification should be obtained from the practitioner. Hospital personnel may present the form to the patient for signature and sign as witness to that signature. o The patient or patient s legal representative should read the completed form before signing; if necessary, the form may be read to the patient. o Patients with Limited English Proficiency and/or other communication barriers shall be provided interpretive services or auxiliary aids as required. o If the patient indicates that he/she has not received an explanation or does not understand what was explained, the form should not be signed; the practitioner should be notified of the situation. o By witnessing the signature, hospital personnel serve only to verify that the signature on the consent form is that of the patient or the patient's representative; they are not obtaining informed consent for the medical or surgical treatment. o Hospital personnel who witness the signature on a consent form should write their name and professional designation on the line provided for the witness. Normally, one witness is sufficient. 4. If the patient is unable to give consent for reason of incapacity, such as status as minor or mental capacity, the practitioner may obtain consent from an individual legally empowered to act on behalf of the patient. It is the practitioner's responsibility to determine whether or not the patient possesses the mental capacity to consent to the procedure.
Page 3 of 5 A patient who has been involuntarily committed for mental illness pursuant to a court order does not automatically lack the mental capacity to consent, unless the order so specifies. In situations where the patient's mental capacity to consent is questionable, the practitioner's determination, along with the basis for the determination, must be documented by the physician in the patient's medical record. 5. Telephone consents should be obtained only in extenuating circumstances, must be witnessed by a minimum of 1 staff member, and be fully documented in the medical record. 6. The signed consent form is in effect until the procedure has been completed or unless the condition of the patient changes so that re-evaluation of previous consent given is indicated, which is at the discretion of the practitioner. 7. In all non-emergency situations where the patient cannot provide consent and the appropriate legal representative is not reasonably available, the practitioner should be made aware of the situation. Generally, treatment in non-emergency situations will be delayed until appropriate consent is obtained. 8. In a non-emergency situation, informed consent from a minor's parent/guardian should be obtained before commencing with the surgery/invasive procedure associated with significant risk or complication. When the minor's parent/legal guardian is not reasonably available, the practitioner should wait until he/she is available and obtain his/her informed consent before performing the procedure. 9. In an emergency situation, under Iowa law, if a minor child requires surgery or other invasive procedure associated with significant risk or complication, no consent (informed or otherwise) is required. 10. In order to comply with Medicare regulations, informed consent forms must contain the following information: Patient s name and identification number Hospital s name Name of the specific procedure, or other type of medical treatment for which consent is being given Name of the responsible practitioner(s) performing the procedure or administering the medical treatment Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient s legal representative and that all questions asked about the procedure have been answered in a satisfactory manner. Signature of the patient or the patient s legal representative Date and time the informed consent form is signed by the patient or the patient s legal representative Signature and professional designation of hospital personnel witnessing the signature of the patient or the patient s legal representative
Page 4 of 5 11. The completed consent form shall be retained in the medical record. ADDENDUM TO INFORMED CONSENT: Guidelines regarding who may provide Informed Consent 1. A surrogate who is reasonably available may sign a consent form for an adult patient who lacks the mental capacity to consent to treatment before the patient undergoes surgical/invasive procedures. The appropriate surrogate to sign for an adult patient (age 18 or older) who lacks the mental capacity to consent to the procedure is according to the following order of priority: o Designated agent with durable power of attorney for healthcare o The patient's court-appointed guardian o Spouse, unless legally separated o An adult child of the patient o A parent of the patient o An adult sibling of the patient If there is more than one person in the appropriate category of surrogates listed in Section 1.1, who is reasonably available, the consent of one is sufficient provided that none of the others is objecting to the procedure. If objections are made, hospital personnel should notify the involved physician. 2. As a general rule, minor patients (age 17 or younger) may not consent to treatment except in limited circumstances. Minors who are married or are otherwise believed to be emancipated may consent to treatment. o Emancipation is not necessarily a continuing status. The following should be considered in determining emancipated status. Living away from parents or other adult relatives. Financially independent; does not rely on parents or other adult relatives for money to meet basic needs. Minors who have children may consent to treatment of their children unless there is reason to believe the minor parents lack the mental capacity to consent. 3. For a minor patient, either of the patient's parents may consent to treatment on behalf of the minor patient. If the patient's parents are divorced, either parent may sign the consent form. If the patient has no living parents or parental rights have been terminated, the patient's legal guardian has the authority to sign the consent form. Representation by the legal guardian may be relied upon. A step-parent may sign the consent form if the step-parent has legally adopted the patient. If the patient is in foster care and the parents' parental rights have not been terminated, a parent must sign the consent form. RELATED DOCUMENTS: REFERENCES:
Page 5 of 5 CMS COPS, 42 CRF 482.13(B)(2); 482.24 (C)(2) (V); 482.51(B)(2). AND INTERPRETIVE GUIDELINES FOR TAGS A-0049 (PATIENT S RIGHTS), A-0238 (MEDICAL RECORDS), AND A-0392 (SURGICAL SERVICES).