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Informed Consent pol..

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    Informed Consent pol.. Informed Consent pol.. Document Transcript

    • Policy & Procedure Policy Origin Date: May 2008 Review Date: December 2009 Revised Date: Effective Date: June 2008 Owner: Medical Executive Committee Reviewed/Recommended By: Medical Executive Committee Function: Medical Staff Policy Department(s): Medical Staff Approved By: Medical Executive Committee Responsible Associates: Medical Executive Committee Approval Date: June 2008 This policy replaces all other existing policies/procedures on the effective date.  Saint Joseph Regional Medical Center TITLE: INFORMED CONSENT POLICY: 1. It is the policy of Saint Joseph Regional Medical Center, Inc. that a patient or patient representative shall give voluntary and informed consent for all care, treatment and services involving material risk. 2. The purpose of obtaining informed consent is to provide information to the patient regarding appropriate care, treatment and services options. This is a process of information exchange that allows the patient to make an informed choice. 3. In non-emergent situations, the patient shall receive a clear explanation of his or her condition and of proposed invasive procedures or of proposed non-invasive procedures that carry a material risk of adverse outcome. The patient shall be informed of the possible benefits of the care, treatment and services, possibilities of any material risks of side effects of the care, treatment and services, and alternative forms of care, treatment and services. GUIDELINES/PROCEDURE: CONTENT GUIDE A. Definitions B. Standards 1) Types of Consent 2) Patient/Licensed Independent Practitioner (LIP) Discussion 3) Requirements for a Valid Consent Form 4) Medical Record Documentation 5) Frequency of Obtaining Consent 6) Incorrect or Incomplete Consent 7) Unanticipated Condition During Surgery or Procedure 8) Waiver of Consent 9) Person(s) Responsible for Obtaining Consent 10)Authorized Persons Who May Provide Consent 11)Persons Not Authorized to Provide Consent 12)Witnessing of Consent Forms 13)Emergency Situations Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 2 of 17 14)Fax, and Telephone/Verbal Consents 15)Law Enforcement 16)Refusal to Consent/Revocation of Consent C. References 1) Definitions a) Adult - A patient, 18 years or over, or a patient under the age of 18 who is “emancipated.” A minor is deemed emancipated for the purpose of this policy if he/she documents that he/she is either: (1) Married; or (2) On active duty with the Armed Forces of the United States; or (3) Emancipated by virtue of a court order; or (4) In the custody of law enforcement agency and a parent or guardian cannot be located. b) Capacity – Understanding the nature and consequences of one’s actions. (1) Components of capacity include the ability to: (a)Comprehend the information intellectually; (b)Process the information; and (c)Understand the consequences of the decision at hand. (2) Medications can impair capacity temporarily; it is the physician’s responsibility to determine whether a patient who has received medication is capacitated for the purpose of giving consent in any given situation. (3) Adults are presumed capacitated unless determined otherwise. c) Consent Form – A document showing consent given for care, treatment and services, an operation, clinical research, anesthetic or sedative, blood or blood products, or other procedures and treatments, signed by the patient or authorized person, and with a witnessing signature being indicated on the form. A signed consent implies knowledge of what one is signing, what is to be done, and an understanding of the risks, and benefits of the care, treatment and services or procedure and/or alternatives. d) Emergency – A sudden, unexpected occurrence in which there is an imminent danger to a person’s life or limb that demands immediate medical attention and any delay in initiating treatment could add to that danger. e) Incapacitated Person – An adult impaired by physical illness or disability, mental illness or deficiency, or the use of drugs, alcohol, or other causes to the extent that the person lacks sufficient understanding or capacity to make and communicate reasonable decisions concerning his/her person and/or care, treatment and services. f) Informed Consent – Consent given by a patient or by the legally authorized representative, for care, treatment and services after receiving information either verbally or in writing from the physician. The informed consent process is intended to enable the person to understand 1) the nature and purpose(s) of the care, treatment and services consented to, 2) the associated benefits and risks of the care, treatment Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 3 of 17 and services, 3) possible complications, 4) likelihood of achieving care, treatment and services goals, and 5) possible other reasonable care, treatment and services options, including risks, benefits and side effects related to these alternatives, 6) the right to refuse treatment and any consequences related to the refusal and when indicated, 7) any limitations on the confidentiality of information learned from or about the patient. The patient or the legally authorized representative shall have opportunities to ask and have questions answered. A patient's right to decide whether or not to receive medical care, treatment and services establishes the LIP’s duty to inform the patient about the recommended care so that the patient's decision is meaningful. LIP’s are responsible for disclosing information they know would be significant to a reasonable person in the patient's condition and circumstances. LIP’s have no obligation to provide treatment or services deemed medically unnecessary or inappropriate. (1) In order to give informed consent, the patient must be informed of: (a)The nature of the proposed care, treatment, services, medications, interventions, or procedures; (b)Potential benefits, risks, or side effects, including potential problems related to recuperation; (c)The likelihood of achieving care, treatment, and service goals; (d)Reasonable alternatives to the proposed care, treatment, and service; (e)The relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and services; and (f) When indicated, any limitations on the confidentiality of information learned from or about the patient. g) Invasive Procedures – Most procedures involving puncture or incision of the skin, or insertion of an instrument or foreign material into the body, including, but not limited to, percutaneous aspiration of abscesses or fluid collections, biopsy, cardiac or vascular catheterization, endoscopy, angioplasty, and implantation of a device. Invasive procedures require patient informed consent. See “Procedures Requiring Informed Consent.” h) Legal Guardian or Representative– A person appointed by the court, whether as guardian, conservator, or patient advocate or person permitted by state law to act for an incapacitated patient. A copy of “Letters of Authority” issued by the appropriate Probate Court should be contained in the patient’s medical record as evidence of the legal guardian’s authority to give consent for the patient. The authority of the legal guardian or representative ends when patient capacity is regained. i) Licensed Independent Practitioner (LIP)--A health care provider licensed by the state and duly qualified to provide independent care in the hospital. MD’s, DDS’, DPMs, DO’s, ARNP’s and midwives are LIP’s Note: Physician Assistants (PA’s) are also authorized to handle the informed consent process under the sponsorship of a physician. D. Material Risk – A risk a reasonable person would find important in determining his or her course of action. Material risks could include risks that are highly likely to occur but that Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 4 of 17 would not result in serious injury. It also includes those risks that are rare but have the potential for causing serious injury. 1) Minor – A person who is under age 18 and does not meet the criteria for being emancipated. 2) Parent – A birth parent or adoptive parent of a minor. 3) Standards a) Types of Consent: (1) Operation/invasive procedure (a)Except in emergencies, informed consent shall be obtained and documentation placed in the patient’s chart prior to the performance of operations or invasive procedures that have a material risk of serious injury to the patient or that have a low frequency of occurrence but are serious in nature. (b)A signed consent is necessary for the following operative or invasive procedures and/or therapies found in Appendix 1, and other procedures as determined by the organized medical staff and documented in medical staff by- laws or policy: (2) Non-invasive care, treatment and services of a diagnostic or therapeutic nature, and specialized consents. (a)Where a material risk of harm exists, the attending LIP supervising the care, treatment and services or procedure shall be responsible for ensuring that the patient has been properly informed regarding the care, treatment and services and documenting this process. (b)Other matters requiring a signed consent include but are not limited to: [1] Admission to hospital; [2] Admission to Emergency Department; [3] Refusal of blood transfusion; [4] EMTALA transfer from facility; [5] Patient leave of absence; [6] Patient discharge against medical advice; [7] Patient photography, video taping and other imaging; [8] Patient consent to presence and role of health care industry representative in the operating room; [9] Body disposition form. (3) Research consent (a)Informed consent shall be obtained prior to any care, treatment and services or procedure that is part of a research study in accordance with an Institutional Review Board, (IRB) approved protocol. (b)The investigator or another LIP with specific knowledge of the research shall properly inform the patient regarding the experimental procedure(s) or care, Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 5 of 17 treatment(s) and service(s) as required by federal regulations and by the IRB approved protocol and consent form. (4) Anesthesia (a)Separate written consent for anesthesia is required for all surgical interventions. (b)Specific written consent is required for independent diagnostic and therapeutic anesthesia procedures, such as therapeutic nerve blocks. (5) Sedation (a)Consent for sedation is not implied. Informed consent for sedation associated with a procedure, operation or care, treatment and services shall be obtained in conjunction with the consent obtained for the procedure or care, treatment and services itself. (6) Specialized consents: (a)Consent shall be obtained for care, treatment and services or procedures and high risk medications that although common, may have rare but serious side effects or consequences. Examples include blood transfusions and certain immunizations. (7) Consents required by statute (a)In certain cases, State or Federal law mandates consent. [1] HIV, genetic tests and alternative care, treatment and services for breast cancer are required by State law. [2] State law requires a special process of consent for termination of pregnancies. [3] In certain circumstances, State law may require patient consent to administration of psychotropic medications. E. Patient/LIP Discussion 1) For all care, treatment and services, including surgeries, invasive procedures and non- invasive care, treatment and services or procedures, a discussion with the patient or legal guardian or representative shall be held. It is the responsibility of the LIP to provide the patient with the information in a manner that the patient or legal guardian or representative can understand, which, in the LIP’s medical judgment, is necessary to formulate a reasoned decision regarding acceptance of the care, treatment and services. 2) The discussion shall include the following points: a) Detailed explanation of the procedure, including: (1) The nature of the proposed care, treatment, services, medications, interventions, or procedures (2) Potential benefits, risks, or side effects, including potential problems related to recuperation (3) The likelihood of achieving care, treatment, and service goals Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 6 of 17 (4) Reasonable alternatives to the proposed care, treatment, and service (5) The relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and services (6) Whether practitioners other than the primary surgeon, including residents, may perform important surgical tasks, including opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices and placing invasive lines. (7) Statement, if applicable, that qualified medical practitioners, including but not limited to residents, may perform important surgical tasks, in accordance with hospital policy and based on their skill set and under the supervision of the surgeon. (8) When indicated, whether the patient wants Do Not Resuscitate Orders suspended during surgery. 3) During the discussion the patient is allowed to ask questions and once satisfied, the patient makes a choice. The patient’s informed consent after disclosure of the information set forth above shall be evidenced by signing and dating the form by the patient or patient representative and/or with a progress note authored by the LIP F. Requirements For A Valid Consent Form 1) If the patient chooses to proceed, for all operations and for invasive procedures that carry material risk, a consent form shall be signed by the patient or the legal guardian or representative before that care, treatment and services is begun. 2) A valid consent form must include: a) The patient’s legal name, and when appropriate, the name of the patient’s legal guardian or representative; b) The name of the hospital; c) The complete name of the surgery, procedure or diagnostic test to be performed, as written specifically by the physician on the Physician’s Order Sheet, or as documented in the record. If the LIP has not written the name of the procedure on the Physician’s Order Sheet, the complete name of the surgery or diagnostic test to be performed is to be taken from the Operating Room schedule. Abbreviations shall be avoided; d) Indication or listing of the material risks that were discussed with the patient; e) Alternative procedures, care, treatment, and services; f) The patient’s signature, responsible person’s signature if patient is under eighteen (18) years and not an emancipated minor, legal guardian or representative; g) The date and time the consent signature is obtained; h) A statement that the procedure was explained to the patient or the legal guardian or representative; i) The name and signature of the LIP who explained the procedure to the patient or legal guardian or representative shall appear on the form; Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 7 of 17 3) The name and title of the person witnessing the signature. The witness must be eighteen (18) year of age or older. If the witness is other than the physician who explained the procedure to the patient, the witness is only witnessing the signature of the patient, and is not witnessing the Informed Consent discussion or attesting to the patient’s understanding of the discussion. 4) Consent may be obtained by the LIP outside of the hospital and faxed to the hospital. Properly executed, legible faxed copies on an appropriately completed hospital form shall be accepted and are binding as the original. 5) Patient refusal of recommended care, treatment and services or revocation of a valid consent may be documented on the consent form or in the medical record. G. Medical Record Documentation Documentation of the consent process may be included in any of the following: 1) Consent Forms; 2) All other consents: The informed consent discussion may be documented in the medical record as a narrative dictated or written note (inpatient or outpatient progress note or operative report as appropriate) by the LIP who had the informed consent discussion with the patient. 3) Emergency situation: In an emergency when the usual consent process cannot be followed, the LIP shall document in a progress note in the patient’s chart: a) The circumstances that do not allow consent to be obtained; b) The efforts by Trinity Health to obtain such consent; c) The circumstances that constitute an emergency need for care, treatment and services, including the risks to the patient if the treatment is not performed or is delayed. 4) Research Consent: Three (3) copies of the IRB approved consent form shall be completed following the informed consent discussion. One (1) form is placed in the medical record prior to care, treatment and services. The principal investigator shall keep one (1) copy of the complete set of written and signed consent forms. The patient shall be given one (1) copy of the consent form, in accordance with federal regulation. H. Frequency of Obtaining Consent 1) The patient’s informed consent shall be obtained before each procedure or for the duration of each course of care, treatment and services as long as the risk remains unchanged. 2) The need for obtaining a new informed consent shall be evaluated whenever the course of care, treatment and services or the patient’s condition is substantially altered. 3) If concerns arise over the validity of a patient’s consent, because significant time has elapsed between consent and the care, treatment and services or procedure, or for any other reason, staff should discuss those concerns with appropriate supervisor or patient’s LIP 4) For continuing and repetitive courses of care, treatment and services (outpatient examples include allergy shots, dermatology treatment for acne, orthodontia) (inpatient examples include ECT, chemotherapy, pain management, radiation oncology, rehabilitation therapy) providers may use a single consent for continuing care. Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 8 of 17 5) The consent remains valid: a) Until the patient revokes it; b) If the procedure, care, treatment and services must be postponed due to reasons not related to a change in the patient’s medical status (e.g., LIP unavailability); c) Until the patient is discharged (new consents shall be obtained upon readmission). d) Research consents: Informed consent shall be obtained as required by federal regulation and by the IRB approved protocol. It shall be obtained again whenever the experimental protocol is substantially altered. I. Incorrect or Incomplete Consent 1) Minor errors or incompletion (e.g., a misspelled word) that do not materially change the consent need not be corrected. 2) Major errors or incompletion (e.g., wrong site surgery) that materially change the consent must be discussed with the LIP. a) If the LIP determines that the patient was fully informed and that delay may cause harm to the patient, corrected consent shall be obtained from the patient’s legal guardian or representative and the procedure may be done. b) If it is determined that the patient was wrongly advised or provided incorrect information, the procedure must be postponed until appropriate consent is obtained. J. Unanticipated Condition During Surgery or Procedure 1) If a physician encounters an unanticipated condition during surgery and the patient is under general anesthesia, the physician may ordinarily treat the condition without obtaining the patient’s additional informed consent, however, will inform the patient, legal guardian or representative at the first available opportunity. 2) However, additional informed consent shall be obtained if treating the unanticipated condition would materially alter risk or expected consequences of the care, treatment and services, unless waiting to obtain additional informed consent would endanger the patient’s life. K. Waiver of Consent 1) A patient may waive the right to informed consent. 2) The LIP should document the patient’s waiver in the medical record. L. Person(s) Responsible For Obtaining Consent 1) LIP a) The LIP who is to perform or supervise a contemplated operation or procedure is responsible for obtaining informed consent from the patient or the patient representative. b) The LIP shall discuss with the patient or patient representative an explanation of the operation or procedure. M. Authorized Persons Who May Provide Consent 1) A capacitated adult patient. Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 9 of 17 2) The legal guardian or representative of an adult incapacitated patient. 3) A parent or legal guardian of a minor, except as provided by State or Federal law. 4) An emancipated minor 5) An unemancipated minor of any age may give valid informed consent in specialized circumstances. The following are common examples of specialized circumstances when an unemancipated minor may consent: a) Substance Abuse (1) A minor may consent to substance abuse-related care without parent or guardian contact or consent. For medical reasons only, the parent or guardian may be informed as to the care, treatment and services given or needed, and minor may not prevent such a disclosure made for medical reasons. b) Mental Health Care, Treatment and Services (1) A minor fourteen (14) years or older may request and receive a maximum of 12 outpatient mental health sessions (excluding pregnancy termination services or use of psychotropic drugs) without consent of a parent or guardian. Parent or guardian shall not be informed of the services without consent of minor unless there is a compelling need for disclosure based on substantial probability of harm to minor or other and if minor is notified of mental health professional’s intent to inform parent or guardian. c) Sexually Transmitted Diseases (1) A minor infected with sexually transmitted disease (including HIV) may consent to care, treatment and services without consent of parent or guardian. For medical reasons, the physician may inform the spouse, parent or guardian as to care, treatment and services given or needed. HIV testing and disclosure laws apply to minors as they do to adults. d) Prenatal and Pregnancy Related Healthcare (1) Minor may consent to prenatal and pregnancy related care. The minor shall be informed before care, treatment and services is initiated that the putative father of the child or the parent or guardian may be notified. The physician or other health professional may for medical reasons, but is not obligated to, inform the putative father, parent or guardian of the care, treatment and services needed or given. At the initial visit, the minor shall be asked for permission to contact the minor’s parents for any necessary or helpful medical information. e) Child of a Minor (1) A minor may consent to healthcare to a child of the minor. The minor shall be informed before care, treatment and services is initiated that the putative father of the child or the parent or guardian may be notified. The physician or other health professional may for medical reasons, but is not obligated to, inform the putative father, parent or guardian of the care, treatment and services needed or given. At the initial visit, the minor shall be asked for permission to contact the minor’s parents for any necessary or helpful medical information. f) Blood Donation Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 10 of 17 (1) A minor aged seventeen (17) or older, may donate blood in a voluntary and non- compensatory blood program without the necessity of obtaining parental or a guardian’s consent. 6) If a question of consent arises, staff may refer to Legal Department or Risk Management. N. Special Circumstances Impacting Communication and the Consent Process 1) Illiteracy or physical handicap a) Consent given by physically handicapped or illiterate patients is valid where documented special efforts are made to enable the patient to understand the nature and risks of a procedure, care, treatment and service despite the particular handicap. b) The patient is physically unable to sign his/her name. (1) If the patient can make a mark, the patient should do so on the consent form. The person witnessing the form should write on the form that he/she witnessed the patient make this mark. (2) If the patient cannot make any mark, the patient should ask someone else to sign his/her name. That person should sign the patient’s name and his/her own name. The person witnessing the form should write on the form that he/she witnessed the third party sign at the patient’s request. c) Foreign Language speaking patients (1) If a patient has difficulty understanding or speaking English, the facility should make reasonable efforts to obtain an interpreter or otherwise communicate with the patient before consent can be given. Use of family members to interpret is strongly discouraged. Only the patient can sign the consent form, but the interpreter should also sign his/her name on the form with a short note indicating that he/she translated the form and the explanation provided by the LIP performing the procedure. O. Persons Not Authorized to Provide Consent 1) Non-emergent medicated patients: a) Consent for care, treatment and services are not valid if obtained when a patient is medicated and not alert. A patient may not sign a consent form after the administration of a narcotic, barbiturate or tranquilizer, whether scheduled or P.R.N, and whether pain medication or pre-operative medication until the patient appears to be alert. (1) For the purposes of consent, “alert” means that a person is conscious and aware of what they say and what is said to them. (2) If the judgment of the LIP performing the procedure or the legal guardian or representative is that the patient’s condition does not allow the patient to give valid consent, further time shall be allowed to pass prior to reassessment of the patient. (3) The consent form shall not be signed until the LIP performing the procedure determines the patient’s condition allows the patient to give informed consent. Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 11 of 17 Documentation should reflect this evaluation process of the patient’s decision- making capacity. 2) Non-emergent, incapacitated patient: a) LIP’s, admitting personnel, and nursing staff should anticipate any apparent lack of capacity to give informed consent as early as possible in the hospitalization. b) Consent by a patient who is unable to understand the nature and risk of a procedure is not valid and consent must be obtained through the alternative procedures as described below. 3) Other persons who may provide consent a) When non-emergent medical or surgical care, treatment and services are required for incapacitated adults, informed consent should be obtained from one of the following persons: (1) Legal Representative (a)Medical Power of Attorney for Health Care ("MPOA") or Guardian. The court's appointment of the guardianship must expressly grant authority to make medical care, treatment and services decisions. (2) Family Members (a)If a patient has neither a duly appointed MPOA nor guardian, consent for care, treatment and services may be obtained from the patient's family, including spouse, adult child, parents, adult sibling, and adult grandchildren. Caregivers should make every attempt to identify significant family conflict and utilize hospital resources, i.e. risk manager, legal counsel, and Ethics committee, to manage the conflict. (3) Court Order (a)When a patient requiring non-emergency medical care, treatment and services is determined to be incapacitated to give informed consent, and there is no legal representative or available family member able to consent, it may be appropriate to seek court intervention. P. An unemancipated minor / Minor child 1) Minor Child in the Custody of a Parent a) Either parent (unless parental rights have been terminated) or guardian may sign the consent for care, treatment and services of the minor child. 2) Minor Child with a Guardian a) Prior to relying on consent of a guardian, the Letters of Authority should be requested, reviewed for verification of whether the guardianship is effective, and whether there are any limitations on the authority of the guardian to make medical decisions. A copy of the Letters of Authority should be placed in the medical record. 3) Minor Child with Temporarily Absent Parent or Guardian a) When a parent or guardian is temporarily absent, a person who has been given authority by the parent or guardian may consent to medical care, treatment and Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 12 of 17 services for the minor child. Such authority is valid only for a period of six (6) months from the date of signing. The documenting authority to consent should be examined to determine whether it is in effect, and whether there are any limitations on the type of procedures or care, treatment and services to which the person who is granted the authority may consent. 4) Minor Child Not Living At Home and Without Guardian a) If a minor is not living with his/her parents and does not have a legal guardian, consent to routine non-surgical medical care may be obtained from the Court. 5) Minor Child Who Lives in a Foster Home a) If the minor has been living in a foster home, the Agency making the placement or the Court may name a guardian, who shall have authority to consent to routine, non- surgical medical care of the child. If the child has been voluntarily placed in the foster home, the parents or guardian may consent to routine, non-surgical medical care. Furthermore, only the minor child’s parent or legal guardian may consent to non- emergency, elective surgery for the child. 6) Minor is a State Ward and Lives in a State Residential Facility a) If the minor is a state ward and has been placed in the residential facility, the Agency may consent to routine, non-surgical medical care. Q. Witnessing of Consent Forms 1) The signing of forms documenting informed consent for invasive, non-invasive and special procedures shall be witnessed. a) Registered and Licensed Practical Nurses, Advance Practice Nurses, residents in training, or Physician Assistants may sign as the witness on the consent form. 2) The witness’s signature on the consent form only attests to the fact that the patient signed the form, not to the patient’s, guardian or representative’s understanding of the content of the form. 3) In the event that the patient or the legal guardian or representative informs the witness he/she does not understand the procedure, or the lack of understanding is manifest from the statements or actions of the patient or such other person, the witness shall: a) Notify the attending LIP; b) If, after notifying the attending LIP, the patient’s questions remain unanswered, notify the Nurse Manager/Administrative Coordinator on duty at the time, which shall contact the department chair and/or president of the medical staff; c) Document in the patient’s medical record the steps taken to provide adequate information to the patient; d) If a capacitated patient expresses serious reservation and/or appears to be inadequately informed, the department chief and/or chief of staff can authorize non- intervention until such time as a LIP provides information to the patient’s satisfaction. Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 13 of 17 R. Emergency Situations 1) Consent is implied in a true emergency in which immediate care, treatment and services are required for the preservation of life or limb. In such circumstances informing and securing the express consent of a legal guardian or representative (if any) is encouraged but not required. 2) There are three (3) important requirements for the emergency to justify acting without a consent: a) There must be a threat to life or health (serious permanent harm) of the patient; b) The threat must be an immediate one and under the circumstances there is insufficient time to obtain consent; and c) The responsible LIP and the hospital staff shall document in the medical record the medical need for proceeding with care, treatment and services without consent. 3) The medical record documentation shall: a) Clearly indicate the immediacy of the threat to life or health (the nature and magnitude); b) Include the attempts made to secure a consent and why a valid consent could not be obtained from the patient or patient representative; and c) Indicate the performed procedure was only that which was necessary to remove the immediate threat to the patient’s life or health. S. Fax and Telephone/Verbal Consents 1) Fax Consent a) Fax consent is acceptable in those cases where the individual authorized to consent is unable to come to the hospital and the patient is unable to give a valid consent. 2) Telephone or Verbal Consent a) In extenuating circumstances, the verbal/telephone consent of a person authorized to consent for a patient may be given by telephone. (1) The LIP performing the procedure shall conduct the discussion, documenting the explanation and the time of the call in the Progress notes on the patient’s medical record. After receiving an explanation from the treating LIP as to the risks, benefits and alternatives, verbal consent of a person authorized to consent for a patient may be given by fax or telephone. (2) A witness must listen to the telephone authorization and record pertinent data on appropriate chart form. The consent form should indicate the name and address of the authorized person giving consent, the date and time of the consent, and the signatures of the persons who witness the verbal consent. The witness’ signatures on the consent form only attest that the authorizing person provided verbal consent, not to the person’s understanding of the information provided by the physician. The staff may witness the authorized person’s consent by asking the person to repeat their consent to both staff members or by a conference call with all participants. T. Law Enforcement Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 14 of 17 1) If a police officer requests that a test be performed on a patient to determine the amount of alcohol or presence of a controlled substance, or both, in the patient’s blood, the police officer is responsible for obtaining written consent of the patient or legal guardian or representative. A copy of the written consent is included in the patient’s medical record. If the patient refuses to submit to the test, the hospital shall honor the patient’s wishes and not proceed with the test unless there is a court order/search warrant. Assuming a court order/search warrant has been obtained, the hospital shall abide by the court order/search warrant. U. Refusal to Consent/Revocation of Consent 1) An adult or emancipated minor, who is conscious and mentally capacitated, or the parent(s) of a minor, have the legal right to refuse any medical or surgical procedure or information pertaining to the proposed care, treatment and services. 2) The refusal to consent must be honored whether the refusal is grounded upon a doubt that the contemplated procedure shall be successful, a concern about the probable or possible results of such a procedure, fear, religious belief or mere whim. However, in the case of a minor, when care, treatment and services is necessary to preserve life (i.e. blood transfusion for the child of a Jehovah Witness), the health care facility may petition the court for a decision. 3) It is recommended that no elective procedure be performed if the patient refuses to consent. The health care facility and the attending LIP should render the best possible care under the circumstances and document patient refusal in the medical record. a) The patient/authorized person should be counseled as to the effect of refusing the proposed plan of care. When counseling, the LIP may utilize available resources (i.e., physician, nurse, patient representatives, Social Worker, Chaplain) to assist the patient in the decision-making. b) A brief description of the circumstances and attempts to address the reasons for refusal should be documented in the medical record so that it demonstrates that the attending LIP used due care in recommending the proper care, treatment and services for the patient. c) In emergent cases where the patient or the parent(s) of a non-emancipated minor has given express refusal to consent, but, it is nevertheless deemed essential according to medical judgment of the attending LIP that care, treatment and services should be administered immediately to preserve life or present impairment of health, the matter should be promptly referred to the Legal Department, Ethics Committee or Risk Management before any care, treatment and services is rendered. 4) A patient may revoke a valid consent at any time during his/her course of care, treatment and services. REFERENCES • The Joint Commission, The Comprehensive Accreditation Manual for Hospitals (CAMH) Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 15 of 17 • Centers for Medicare and Medicaid Services, Medicare Conditions of Participation and Interpretive Guidelines. • Appendix I Table Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 16 of 17 Appendix I 1. All procedure performed in the operating room 2. All procedures requiring the use of moderate (conscious) or deep sedation. 3. Transfusion of blood and/or blood products. • Other Procedures Requiring Informed Consent Amniocentesis Anesthesia (all types and procedures except local and topical) Angiography, Angioplasty, Stenting, Coiling, or Embolization Aspiration Procedures from Organs or Body Cavities Autopsy Bacille Calmette-Guérin (BCG) Intravascular Instillation Biopsy Procedures (all organs and tissues excluding skin biopsies) Burn Care with Reconstruction (all sites) Cardioversion (elective) Catheterization: any location including Dilatation, Stenting, Puncture or Ablation excluding Intravenous and Standard Peripheral sites and Urinary Bladder Central Line Insertion (elective) Cervical Ripening and Induction of Labor Chemotherapy (initial cycle) Circumcision Cosmetic Procedures: Injections, Implantation, Reduction, Surgery, Suction, Topical Skin Resurfacing and Laser Use Cystoscopy Dental Restorative Procedures and Treatments Dialysis (initial session), Insertion of Catheter Electro Physiologic Studies (EPS) Endoscopies (all body organs or orifices) Extracorporeal Shock Wave Lithotripsy (ESWL) External Cephalic Version Florescence Angiography (initial session) Intravenous Immunoglobulin (IgG) IV therapy (initial session) Pol. 162
    • Saint Joseph Regional Medical Center Policy/Procedures Effective October 2009 Date: INFORMED CONSENT – continued Page 17 of 17 Pacemaker / Defibrillator Insertion (permanent) Intubations (elective) excluding Oral or Naso Gastric Intubations Invasive Diagnostic: Lumbar Puncture, Thoracentesis, Paracentesis, Joint Aspiration Invasive Monitoring: Swan Ganz, Arterial Lines, etc. Invasive Therapeutic: Tube Thoracostomy, Paracentesis, Thoracentesis, Punctures, Plasty Procedures Lumbar Punctures Nuclear Medicine Procedures Tests Ophthalmology Procedures under local/ topical Anesthesia Organ Donation Organ Transplant Pneumatic Retinopexy Radiation Oncology Therapy Radioiodine I-131 Therapy for Goiter or Thyroid Cancer Reconstructive Procedures Roacutane Treatment Stress Cardiac Scans / Echo / Tests Subdural Tap Thrombolytic Therapy Trans-Illuminated Powered Phlebectomy Surgery (TIPPS) Transesophogeal Echocardiograms Ultrasounds: Endoscopic or Rectal Pol. 162