If a patient lacks the capacity, (the ability to understand the nature and consequences of the proposed treatment), the patient’s representative has the right to give informed consent or refusal on the patient’s behalf. This includes the following steps:
1. A court
determines the patient’s incapacity per Probate Code 810-814.
Incapacity
determination may be made by the patient’s physician unless the physician’s
determination is disputed by the patient or the patient’s representative. If
incapacity is determined by the physician, that determination and its proponents
must be documented in the patient’s medical record.
A patient’s
representative may be a person designated under the Durable Power of Attorney, a
conservator specifically authorized by a court to make health care decisions
pursuant to Probate Code 1800 and 3200 et seq., a next of kin, any other
appropriate surrogate designated consistent with statutory and case law, or if
the patient is a minor, someone lawfully authorized to represent the minor.
2. Complete Informed Consent Forms, which must include the following:
•Authorization for a specified physician and the physician’s assistants to perform a specified medical procedure (described in both medical and lay terms).
•General description of procedure’s risks that may occur in connection with the procedures, a list of risks specific to the procedure, and a disclaimer statement regarding inability to list all possible undesirable effects and procedures which may or may not improve patient’s condition.
•Alternative methods of treatment, their risks and benefits, and why the physician recommends the specified procedure.
•Anticipated benefits of the specified procedure with a disclaimer regarding guarantees or assurances.
•Encouragement to the patient and representative to ask questions concerning the procedure. Answer each question fully.
•The patient’s name, or legal representative, a place for his/her signature, and the relationship of the representative.
•Statement that the patient has had an opportunity to obtain a second opinion.
3. Advise the patient that unforeseen circumstances may arise which may make it necessary or advisable, during the course of the procedure, to perform different or additional procedures. The patient must consent, in writing, to the performance of these procedures.
4. Document whether the patient has received and reviewed additional material concerning the procedure, such as pamphlets, audiotapes, videotapes, slide presentations, and lectures.
5. Encourage the patient or representative to ask questions.
6. Comply with Specific Procedures: Compliance with California statutes is required in the case of assisted reproduction, blood testing in pregnancy, HIV testing, genetic testing, blood transfusions, breast cancer, treatment of patients with Dimethyl Sulfoxide (DMSO), hysterectomy, prostate cancer, silicone implants/collagen injections, research, sterilization, immunizations, electro-convulsive therapy, psychosurgery, psychotherapeutic drugs and physical restraints, human experimentation, and investigational use of drugs and devices.
•Assisted Reproduction: The patient must provide written consent before a physician removes sperm or ova from a patient that will not be reimplanted in the same patient or implanted in the patient’s spouse. The consent must meet the following criteria:
•Be in writing and contain the statement “I, [name of donor] do hereby donate [type and number, if applicable,] of sperm or ova to [name of clinic or recipient] for [specify purpose].
•Contain a statement by the donor that provides for the disposition of any unused donated material.
•Be signed by the patient and the physician who removes the sperm or ova.
•Contain a notification that this is an important document that should be retained with other vital records.
•If the procedure takes place in the hospital, the physician must provide a copy of the consent to the hospital. A violation of the assisted reproduction consent procedure constitutes unprofessional conduct and may subject the physician to civil and criminal liability.
•Blood Testing in Pregnancy: A physician providing prenatal care or attending a woman at the time of delivery must obtain or cause to be obtained a blood specimen on the first visit or within 10 days thereafter, and submit it to an approved laboratory to be tested for syphilis. That physician must also obtain a blood specimen for determination of rhesus (Rh) blood type and hepatitis B.
•HIV Testing: Physicians must offer HIV information and counseling to every pregnant patient.
•Genetic Testing: Physicians must offer genetic testing to every pregnant woman. Physicians must genetically test each child born in California, unless a parent or guardian of the new born child objects on religious grounds (per Health & Safety Code 125000, 17 C.C.R. 6500 et seq. And 6521 et seq.).
•Blood Transfusions: Whenever there is a reasonable possibility that a blood transfusion may be necessary as a result of a medical or surgical procedure, the physician must inform the patient of the benefits and risks of receiving various types of blood transfusion options. The physician must provide the information by means of the standardized written summary (“If You Need Blood”) produced by the State Department of Health Services (DHS). Physicians must obtain and use the most current summary, reviewed by the DHS annually. Copies of the summary may be requested of the DHS by writing to Address, City, ST 55555. The physician must note in the patient’s medical records that the standardized written summary was given to the patient. When no emergency or contraindication exists, the physician must allow adequate time before the procedure for predonation to occur, unless the patient consents to an earlier time. DHS recommends that, in general, the optimal donation period begin 4-6 weeks prior to surgery and the last blood donation be collected no later than 72 hours before surgery.
•Breast Cancer: Health & Safety Code 109275 requires that physicians
provide a standardized summary discussing alternative breast cancer treatments
and their risk benefits. In addition, physicians must note in the patient’s
chart that the physician has given the patient the summary prior to the
performance of a biopsy. Distribution of a brochure prepared by DHS constitutes compliance with the law. This
brochure may be ordered from:
Breast Cancer Treatment Options
1430
Howe Avenue, Suite 50
Sacramento, CA 95825
Phone (916) 263-2466 or Fax
(915) 263-2479
•Health & Safety Code 109277 requires every physician who screens or does biopsies for breast cancer to post a sign with prescribed wording relating to the above brochure. The sign concerning the brochure must be posted near where the breast cancer screening or biopsy is performed or at the patient registration area. The sign must be at least 8-1/2” x 11” and conspicuously displayed so as to be readable. The words “Be Informed” must be at least ½” in height and centered on a single line with no other test. The message must appear in English, Spanish, and Chinese.
•Treatment of Patients with a DMSO Preparation: Special informed consent requirements apply. Before treating a patient with DMSO, the physician must inform the patient, in writing, if DMSO has been approved by the FDA as a treatment or cure for the disorder for which it is being prescribed. If DMSO is being prescribed for any purpose other than those that have been approved under the statues governing new drug and device applications, the physician must first obtain a signed and dated, written informed consent form from the patient.
•Hysterectomies: Physicians must obtain verbal and written informed consent before performing a hysterectomy on any patient, unless the hysterectomy is performed in a life-threatening emergency, in which case, the physician must handwrite and sign a statement certifying the nature of the emergency. The consent must contain the following:
•That the woman is free to withhold or withdraw consent at any time before the hysterectomy without affecting the right to future care or treatment and without loss or withdrawal of any state or federally funded program benefits to which the individual might be otherwise entitled.
•A description of the type or types of surgery and other procedures involved in the proposed hysterectomy, and a description of any known available and appropriate alternatives to the hysterectomy.
•Advice that the hysterectomy procedure is considered to be irreversible, and that infertility will result, unless the patient has been sterile previously or is post-menopausal.
•A description of the discomforts and risks that may accompany or follow the procedure, including an explanation of the type and possible effects of any anesthetic to be used.
•A description of the benefits or advantages that may be expected as a result of the hysterectomy.
•The woman’s signed written statement prior to the performance of the hysterectomy indicating that she has read and understood the written information provided above, and that this information has been discussed with her by her physician or the physician’s designee. Unless the patient has been sterile previously or is post-menopausal, this statement must specifically indicate that the woman has been advised that the hysterectomy will render her permanently sterile and incapable of having children.
•Prostate Cancer: Health & Safety Code 109282 requires every physician who screens for or treats prostate cancer to post a sign with prescribed wording. The sign must be posted near to where prostate cancer screening or treatment is performed or at the patient registration area. The sign must be at least 8-1/2” x 11” and conspicuously displayed so as to be readable. Moreover, the words “Be Informed” must be at least ½” in height and centered on a single line with no other text. Finally, the message must appear in English, Spanish and Chinese. DHS recommends the use of forms and summaries produced by the National Cancer Institute. These may be obtained by calling them at (800) 4CANCER.
•Silicone Implants/Collagen Infections: The Cosmetic Implant Act of 1992 (Business and Professions Code 2259 and 2259.5) requires physicians to supply silicone implant patients a standardized written summary describing the risks and possible side-effects of silicone implants used in cosmetic, plastic, reconstructive, or similar surgery before the physician performs the surgery. In addition, collagen injection patients must receive similar materials regarding collagen injection. The physician must also note in the patient’s chart that the patient was given the standardized written summary or other written information required under these laws. DHS recommends that until DHS summaries are available, physicians should distribute the material prepared by manufacturers since such materials are FDA approved.
•Research: A physician is required to inform a patient of the physician’s research or other economic interests, and must obtain an informed consent.
•Sterilization: For private pay, an adult or a minor with legal capacity to consent to medical treatment can consent to sterilization. For Medi-Cal, a patient must be at least 21 in order to consent to sterilization. A person must also be able to understand the content and nature of the informed consent process prescribed in application regulations and be able to give voluntary consent to the sterilization. A competent person may not give informed consent to be sterilized if the person is in labor or within 24 hours after birth, after an abortion, seeking to obtain or obtaining an abortion, or under the influence of alcohol (ETOH) or other substances that affect the individual’s state of awareness. An incompetent person can be sterilized pursuant to a court order under certain circumstances. Sterilization informed consents must be obtained as follows:
•The person who obtains the consent provides the individual with a special consent form and a patient pamphlet on sterilization, both published by the DHS in Spanish and English. The sterilization pamphlets are “Understanding Sterilization” and “Understanding Vasectomy.” The consent forms are “Medi-Cal/Federally Funded Patients Consent Form” PM 330, and “Consent Form (Non-Federally funded” PM 283. These forms and pamphlets may be requested from DHS at 1037 N. Market Blvd., Suite 9, Sacramento, CA 95834.
•The person who obtains the consent must offer to answer any questions the individual to be sterilized may have concerning the procedure.
•The person who obtains the consent must orally provide all of the following information:
•Advice that the individual is free to withhold or withdraw consent to the procedure at any time before the sterilization without affecting the right to future care or treatment and without loss or withdrawal of any federally funded program benefits to which the individual might be otherwise entitled.
•A full description of available alternative methods of family planning and birth control.
•Advice that the sterilization procedure is considered to be irreversible.
•A thorough explanation of the specific sterilization procedure to be performed.
•A full description of the discomforts and risks that may accompany or follow the performing of the procedure, including an explanation of the type and possible effects of any anesthetic to be used.
•A full description of the benefits and advantages that may be expected as a result of sterilization.
•Approximate length of hospital stay and time for recovery.
•Financial cost to patient.
•Information that the procedure is established or new.
•Advice that the sterilization will not be performed for at least 30 days, except under certain circumstances.
•The person who obtains the consent must take steps to ensure that the patient understands the above information. This includes ensuring that information was effectively communicated to a blind, deaf, or otherwise disabled patient. If necessary, you must provide an interpreter to the patient so that information is communicated in the patient’s language. You must permit the patient to have a witness of the patient’s choice when the patient gives consent.
•The consent form must be signed by the patient, interpreter, if one is used, the person who obtained the consent, and the physician who will perform the procedure.
•In signing the consent form, the person obtaining the consent must certify that he/she advised the patient before the patient signed the consent form that no federal benefits may be withdrawn because of a decision not to be sterilized, that he/she orally explained the requirements for informed consent as set forth on the consent form, and that he/she determined to the best of his/her knowledge and belief that the patent understood the content and nature of the informed consent process and knowingly and voluntarily consented to be sterilized.
•The interpreter must certify that he/she transmitted information orally to the patient, read and explained the form to the patient, and determined to the best of his/her knowledge and belief that the patient understood the form prior to signing the form.
•The physician performing the sterilization must certify, by signing the form, that the patient was informed, shortly before the performance of the sterilization, that federal benefits would not be withheld or withdrawn because of a decision to not be sterilized.
•After the appropriate time has passed after the date of the patient’s signature on the form stating he/she understands the procedure, the physician performs the sterilization. A copy of the signed consent form must be provided to the patient and retained by the physician and the hospital in the patient’s medical record.
•Unless an emergency abdominal surgery or premature delivery occurs or the patient voluntarily requests in writing (Medi-Cal patients cannot request this) that the procedure be performed in less than 30 days, 30 days (but not more than 180 days) must pass after the sterilization consent form has been signed by the patient and other appropriate parties before the sterilization procedure can be performed. However, in no case can sterilization be performed in less than 72 hours following the signing of a consent form. The physician must certify shortly before the procedure is performed that one of the above conditions has been met. Additionally, the physician must describe the emergency (for emergency abdominal surgery) or state the expected date of delivery (for a premature delivery) on the consent form. The above requirements apply only to elective sterilization.
•Immunizations: The federal National Childhood Vaccine Injury Act (42 U.S.C. 300aa-1 et seq.) requires that each physician who administers one of several types of vaccines to any person must provide to that person (or if a minor, to the parent or legal guardian) certain specified vaccine information materials regarding the benefits and risks of the vaccine prior to its administration every time a vaccine is administered. The CDC VIS forms may be obtained in 14 languages from the vaccine information materials order line of the DHS at (800) 555-5555. Vaccines for which this information must be supplied are diphtheria, tetanus, pertussis, polio, measles, mumps, and rubella. The information that must be given by physicians to the legal representative of any child or to any other individual receiving one or more of the specified vaccines includes:
•A concise description of the benefits of the vaccine.
•A concise description of the risks associated with the vaccine.
•A statement of the availability of the National Vaccine Injury Compensation Program.
•A copy of the CDC Vaccine Information Statement for the administered vaccine (VIS).
7. Accept implied consent, instead of informed consent, only in the following situations:
•Emergency situations: situations requiring immediate services for alleviation of severe pain or immediate diagnosis and treatment of unforeseeable medical conditions, which, if not immediately diagnosed and treated, would lead to serious disability or death. If the patient is mentally incapacitated and there is no legally authorized representative who can consent on behalf of the patient, a patient will be presumed to have consented to necessary medical treatment. Treatment should not exceed what is necessary to address the emergency. The reasons why the implied consent was invoked will be documented in the medical record.
•Patient requests not to be informed: The patient or patient’s representative asks that he/she not be informed of the risks.
•Therapeutic privilege/physician discretion: In rare situations where a physician can prove that under the circumstances it was reasonable to believe that “the disclosure would so seriously upset the patient that the patient would not have been able to dispassionately weigh the risks of refusing to undergo the recommended treatment,” the physician may withhold the information.
8. A patient can refuse any recommended test, procedure, or medical recommendation after being informed (informed refusal). The physician must inform the patient who refuses to undergo the recommended procedure of the potential consequences. This informed refusal would be documented in the patient’s medical record.
9. A written parental consent is required in order to treat a minor (under age 18) with the following exceptions:
•Minors with divorced parents – Either parent can consent to treatment if parents have joint custody.
•Adopted minors – Adoptive parents can consent to treatment.
•Children of minor parents – The minor parent can consent to treatment.
•Minor pupil – When the child is ill or has been injured during school hours and parents cannot be reached, the child can be treated without parental consent.
•Minor in custody – The minor can be treated when ordered by the court.
•Minor patients with legal capacity to consent to medical treatment, which includes:
•Self-sufficient minor – A minor 15 years of age or older living separate and apart from his/her parents or legal guardian who manages his/her own financial affairs, regardless of the source of income, is capable of giving valid consent. This minor will affirm the above conditions in writing.
•Emancipated minor per court order – If the court order is obtained, the DMV issues an ID card, which states that the minor is emancipated. A copy of this card must be placed in the patient’s medical record.
•Minors on active duty in the US Armed Forces.
•Minors receiving pregnancy care (treatment or prevention).
•Minors 12 years and older suffering from a reportable disease relating to the diagnosis or treatment of that disease.
•Married minor with marital proof (marriage certificate).
•Pregnant Minors (Civil Code Section 34.5) – In addition to the categories of minors who may consent for themselves, there are certain types of care for which minors of various ages may give their consent to treatment:
•Any minor of any age may consent to hospital, medical, or surgical care related to treatment or prevention of pregnancy, except for sterilization procedures.
•It is up to the minor to decide whether to involve her parents in these decisions.
•If a parent requests a copy of the minor’s medical record, the physician can make the birth control or pregnancy information available only with the minor’s authorization.
•The physician can provide the parent with a copy of all information in the record except that pertaining to decisions on pregnancy or birth control.
•A best practice would be to keep minor patient’s birth control and pregnancy information on a separate sheet within the medical record.
•Minor with Reportable Disease, Sexually Transmitted Disease (Civil Code Section 34.7) – A minor age 12 or older may consent to hospital, medical, or surgical care required to diagnose and treat any infectious, contagious, or communicable disease that is reportable to the local health officer.
•Minor Who Is Victim of Rape (Civil Code Section 34.8) – A minor age 12 or older may consent to hospital, medical, or surgical care related to the diagnosis and treatment of rape or alleged rape.
10. Before delivering any health care by telemedicine, a physician who has the ultimate authority over the care or primary diagnosis of a patient must obtain the patient’s verbal and written informed consent. Telemedicine is the practice of health care delivery, diagnosis, consultation, treatment, transfer of medical data, and education using interactive audio, video, or data communications. The informed consent procedure must ensure that at least all of the following information is given to the patient verbally and in writing:
•The patient has the option to withhold or withdraw consent at any time without affecting his or her right to future health care or treatment, and without risking a loss or withdrawal of any program benefits to which the patient would otherwise be entitled.
•All potential risks, consequences, and benefits of telemedicine are described.
•All existing confidentiality protections apply.
•The patient is guaranteed access to all medical information transmitted during a telemedicine consultation, and copies of this information are available for a reasonable fee.
•Dissemination of any patient-identifiable images or information from the telemedicine interaction to researchers or others will not occur without the patient’s consent.
The patient must sign a written statement before the delivery of health care by telemedicine, indicating that the patient understands the written information provided above and that this information has been discussed with the physician, or someone designated by him or her. This law does not apply when the patient is not directly involved in the telemedicine interaction (for example, when one physician consults with another physician). However, all existing confidentiality protections for patient’s medical information apply. The law does not apply in an emergency situation in which the patient is unable to give informed consent and the patient’s representative is not available. The law also does not apply to a patient who is under the jurisdiction of the Department of Corrections.
11. Give a copy of the consent form to the patient, and retain a copy in the patient’s medical record. Copies of court orders and other documents relating to the consent will also become part of the patient’s medical record.
Sample Consent for Treatment
General Consent for Care and Treatment Consent
TO THE PATIENT: You have the right, as a patient, to be informed about your condition and the recommended surgical, medical, or diagnostic procedure to be used so that you can make the decision whether or not to undergo any suggested treatment or procedure after knowing the risks and hazards involved. At this point in your care, no specific treatment plan has been recommended. This consent form is an effort to obtain your permission to perform the evaluation necessary to identify the appropriate treatment and/or procedure for any identified conditions.
This consent provides us with your permission to perform reasonable and necessary medical examinations, testing, and treatment. By signing below, you are indicating that (1) you intend that this consent is continuing in nature even after a specific diagnosis has been made and treatment recommended; and (2) you consent to treatment at this office or any other satellite office under common ownership. The consent will remain fully effective until it is revoked in writing. You have the right at any time to discontinue services.
You have the right to discuss the treatment plan with your physician about the purpose, potential risks, and benefits of any test ordered for you. If you have any concerns regarding any test or treatment recommend by your health care provider, we encourage you to ask questions.
I voluntarily request a physician, and/or mid-level provider (Nurse Practitioner, Physician Assistant, or Clinical Nurse Specialist), and other health care providers or the designees as deemed necessary, to perform reasonable and necessary medical examination, testing, and treatment for the condition that has brought me to seek care at this practice. I understand that if additional testing or invasive/interventional procedures are recommended, I will be asked to read and sign additional consent forms prior to the tests or procedures.
I certify that I have read and fully understand the above statements and consent fully and voluntarily to its contents.
____________________________________________ ____________________________
Signature of Patient or Personal Representative Date
____________________________________________ ____________________________
Printed Name of Patient or Personal Representative Relationship to Patient
____________________________________________ ____________________________
Printed Name of Witness Employee Job Title
____________________________________________ ____________________________
Signature of Witness Date