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Chapter 360-14 INFORMED CONSENT

Rule 360-14-.01 Purpose; Effective Date

The purpose of these rules is to establish the standards for physician compliance with and the standards necessary to implement Code Section 31-9-6.1 of the Official Code of Georgia Annotated (O.C.G.A.) including enforcement thereof through disciplinary action, and to inform all physicians who possess licenses to practice medicine in the State of Georgia of the enactment of said legislation by the General Assembly of the State of Georgia, which will become effective on January 1, 1989, and which will apply to surgical or diagnostic procedures subject to the statutory requirements performed on or after January 1, 1989. These rules will be enforceable and effective January 1, 1989.

Rule 360-14-.02 Definitions

As used in this Chapter:

(1) "Contrast materials" means a non-physiologically occurring molecular compound used to produce density differences in tissues, organs, or vessels to permit visualization of the imaging of such internal bodily structures.
(2) "Direct orders" means orders directly given by or communicated by the responsible physician to persons under the direct or immediate supervision or control of the responsible physician and for whose acts there are direct or immediate responsibility.
(3) "Emergency" means a situation, as defined in Code Section 31-9-3, wherein:
(a) According to competent medical judgments, the proposed major surgical or diagnostic procedures are reasonably necessary; and
(b) A person authorized to consent under Code Section 31-9-2 is not readily available; and
(c) Any delay in treatment could reasonably be expected to jeopardize the life or health of the person affected or could reasonably result in disfigurement or impaired faculties.
(4) "General anesthesia" means a state of unconsciousness and insensitivity to pain affecting the entire body which is produced by the administration of an intramuscular, intravenous or inhalant anesthetic.
(5) "Intravenous injection" means the injection of a substance directly into a vein.
(6) "Likelihood" means the degree or probability of success or failure expressed in general terms or in percentages.
(7) "Major region" means entire arm, leg, torso, or any combination thereof.
(8) "Major regional anesthesia" means a state of insensitivity to pain affecting a major region of the body which is produced by the temporary interruption of the sensory nerve conductivity of such a region through the administration of a spinal, epidural, intravenous regional, or brachial plexus anesthetic.
(9) "Major surgical or diagnostic procedures" means any surgical procedure under general anesthesia, spinal anesthesia, or major regional anesthesia or an amniocentesis diagnostic procedure or a diagnostic procedure which involves the intravenous injection of a contrast material.
(10) "Material risk" means a material risk generally recognized and accepted by reasonably prudent physicians of infection, allergic reaction, severe loss of blood, loss or loss of function of any limb or organ, paralysis or partial paralysis, paraplegia or quadraplegia, disfiguring scar, brain damage, cardiac arrest, or death which could result from the major surgical or diagnostic procedure and which, if disclosed to a reasonably prudent person in the patient's position, could reasonably be expected to cause such prudent person to decline the major surgical or diagnostic procedure on the basis of material risk of injury that could result from the major surgical or diagnostic procedure.
(11) "Medical personnel" means persons under the direct supervision and control of the responsible physician who are duly licensed or authorized to participate in the performance of a major surgical or diagnostic procedure or who are otherwise involved in the course of treatment of the patient's condition.
(12) "Practical alternatives" means practical alternatives to a major surgical or diagnostic procedure which are generally recognized and accepted by reasonably prudent physicians.
(13) "Responsible physician" means the physician who performs the major surgical or diagnostic procedure or the physician under whose direct orders the major surgical or diagnostic procedure is performed by a nonphysician.
(14) "Spinal anesthesia" means a state of insensitivity to pain which is produced by the temporary interruption of the sensory nerve conductivity of a major region of the body through the injection of an anesthetic into the subarachnoid space.

Rule 360-14-.03 Requirement of Consent for Major Surgical and Diagnostic Procedures

Except as otherwise provided in Code Section 31-9-6.1 and these rules, and in particular the exceptions outlined in Code Section 31-9-6.1(e), a person who undergoes any of the following surgical or diagnostic procedures to be performed on or after January 1, 1989, must consent to such procedure as outlined in said Code Section and these rules:

(a) Any surgical procedure under general anesthesia, spinal anesthesia or major regional anesthesia;
(b) An amniocentesis diagnostic procedure;
(c) A diagnostic procedure which involves the intravenous injection of a contrast material.

Rule 360-14-.04 Information Required to be Disclosed; Means of Disclosure

(1) Except as otherwise provided in Code Section 31-9-6.1 and these rules, a person who undergoes a major surgical or diagnostic procedure shall be informed in general terms of each of the following:
(a) The diagnosis of the patient's condition requiring such proposed surgical or diagnostic procedure;
(b) The nature and purpose of such proposed surgical or diagnostic procedure;
(c) The material risks of such proposed procedure as defined in Board Rule 360-14-.02(10);
(d) The likelihood of success of such proposed surgical or diagnostic procedure;
(e) The practical alternatives to such proposed surgical or diagnostic procedure; and
(f) The prognosis of the patient's condition if such proposed surgical or diagnostic procedure is rejected.
(2) The information required to be disclosed pursuant to Code Section 31-9-6.1(a)(1)through(6) and these Rules may be disclosed through any one or all of the following means:
(a) Video tapes;
(b) Audio tapes;
(c) Pamphlets;
(d) Booklets;
(e) Other means of communication; or
(f) Conversations with the responsible physician, other physicians, physician's assistants, nurses, trained counselors, patient educators or other similar persons known by the responsible physician to be knowledgeable and capable of communicating such information.

Rule 360-14-.05 Standards for Physicians Compliance, Sanctions for Noncompliance

(1)
(a) When a responsible physician is required to ensure that consent to a major surgical or diagnostic procedure is obtained and that certain information is provided in connection therewith, such requirement shall have been complied with if accomplished through the use of the form set forth in Exhibit A attached to this Rule or through the use of a form which is substantially similar to such form or which includes provisions substantially similar to such form.
(b) When a responsible physician is required to ensure that consent to a major surgical or diagnostic procedure is obtained and that certain information is provided in connection therewith, such requirement shall be rebuttably presumed to have been complied with if evidenced in writing signed by the patient or other person authorized to sign for the patient.
(2) The failure to obtain the written consent to a major surgical or diagnostic procedure shall not cause such consent and the provision of information in connection therewith to be invalid but no presumption as to the validity of such consent shall arise.
(3) Any physician who fails to comply with these rules shall be subject to disciplinary action under Code Chapter 43-34, and Chapter 360-3 of the Rules of the Georgia Composite Medical Board.

Rule 360-14-.06 Exceptions to Disclosure and Consent Requirements

The disclosure of information and the consent required by these rules shall not be required in connection with a major surgical or diagnostic procedure if:

(a) An emergency exists as defined in Code Section 31-9-3;
(b) The surgical or diagnostic procedure is generally recognized by reasonably prudent physicians to be a procedure which does not involve a material risk to the patient involved;
(c) A patient or other person(s) authorized to give consent pursuant to Code Chapter 31-9, make(s) a request in writing that the information provided for in Code Section 31-9-6.1 not be disclosed or utilizes the form set forth in Exhibit B to this Rule or any other form which is substantially similar to such form or which include(s) provisions substantially similar to such form;
(d) A prior consent, within thirty (30) days of the surgical or diagnostic procedure, complying with the requirements of these rules has been obtained as a part of a course of treatment for the patient's condition; provided, however, that if such consent is obtained in conjunction with the admission of the patient to a hospital for the performance of such procedure, the consent shall be valid for a period of thirty (30) days from the date of admission or for the period of time the person is confined in the hospital for that purpose, whichever is greater; or
(e) The surgical or diagnostic procedure was unforeseen or was not known to be needed at the time the consent was obtained, and the patient has consented to allow the responsible physician to make the decision concerning such procedure.

Exhibit (360-14) A CONSENT TO SURGICAL OR DIAGNOSTIC PROCEDURES

DO NOT SIGN THIS FORM WITHOUT READING AND UNDERSTANDING ITS CONTENTS

Name of Patient______________________ Date________________

(A)
(1) I acknowledge and understand that the following procedure(s) which has (have) been described to me is (are) to be performed on the patient: __________________________________________________________ __________________________________________________________ __________________________________________________________ and that as a result of the performance of the procedure(s) there is a material risk that the patient may suffer infection, allergic reaction, severe loss of blood, loss or loss of function of any limb or organ, paralysis or partial paralysis, paraplegia or quadraplegia, disfiguring scar, brain damage, cardiac arrest, or death.
(2) I acknowledge and understand that during the course of the procedure(s) described in subparagraph (A) (1) above, conditions may develop which may reasonably necessitate an extension of the original procedure(s) or the performance of procedure(s) which are unforeseen or not known to be needed at the time this consent is obtained. I therefore consent to and authorize the persons described in the last paragraph of this consent to make the decisions concerning the performance of and to perform such procedure(s) as they may deem reasonably necessary or desirable in the exercise of their professional judgment, including those procedures that may be unforeseen or not known to be needed at the time this consent is obtained. This consent shall also extend to the treatment of all conditions which may arise during the course of such procedures including those conditions which may be unknown or unforeseen at the time this consent is obtained.
(B) I acknowledge and understand and duly evidence in writing by executing this form that I have been informed in general terms of the following:
(1) A diagnosis of the condition requiring the procedure(s);
(2) The nature and purpose of the procedure(s);
(3) The material risks of the procedure(s) (see paragraph (A) above);
(4) The likelihood of success of the procedure(s);
(5) The practical alternatives to such procedure(s); and
(6) The prognosis if the procedure(s) is (are) rejected; and that such was provided through the use of video tapes, audio tapes, pamphlets, booklets, or other means of communication or through conversations with the responsible physician, or other medical personnel under the supervision and control of the responsible physician, other medical personnel involved in the course of treatment, nurses, physician's assistants, trained counselors, or patient educators.
(C) I acknowledge that there are practical alternatives to the procedure(s) described in paragraph (A) which alternatives reasonably prudent physicians generally recognize and accept.
(D) I acknowledge and understand that this request for and consent to surgical or diagnostic services shall be valid for the responsible physician, all medical personnel under the direct supervision and control of the responsible physician, and for all other medical personnel otherwise involved in the course of treatment. I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK QUESTIONS AND ANY QUESTIONS I HAVE ASKED HAVE BEEN ANSWERED OR EXPLAINED IN A SATISFACTORY MANNER.

BY SIGNING BELOW, I ACKNOWLEDGE I HAVE READ OR HAD IT READ OR EXPLAINED TO ME AND I UNDERSTAND THIS FORM AND I VOLUNTARILY CONSENT TO ALLOW DR._____________ OR ANY PHYSICIAN DESIGNATED OR SELECTED BY HIM OR HER AND ALL MEDICAL PERSONNEL UNDER THE DIRECT SUPERVISION AND CONTROL OF SUCH PHYSICIAN AND ALL OTHER PERSONNEL WHICH MAY OTHERWISE BE INVOLVED IN PERFORMING SUCH PROCEDURES TO PERFORM THE PROCEDURES DESCRIBED OR OTHERWISE REFERRED TO HEREIN.

____________________

Witness

____________________________________

Signature of patient or other person authorized to sign

Exhibit (360-14) B

CONSENT TO SURGICAL OR DIAGNOSTIC PROCEDURES AND WAIVER OF RIGHT TO RECEIVE INFORMATION IN CONNECTION THEREWITH

DO NOT SIGN THIS FORM WITHOUT READING AND UNDERSTANDING ITS CONTENTS.

Name of Patient___________________________ Date___________

(A)
(1) I acknowledge and understand that the following' procedure) which has (have) been described to me is (are) to be performed on the patient:

________________________________________________

________________________________________________

________________________________________________

(2) I acknowlege and understand that during the course of the procedure(s) described in subparagraph (A) (1) above, conditions may develop which may reasonably necessitate an extension of the original procedure(s) or the performance of procedure(s) which are unforeseen or not known to be needed at the time this consent is obtained. I therefore consent to and authorize the persons described in the last paragraph of this consent to make the decisions concerning the performance of and to perform such procedure(s) as they may deem reasonably necessary or desirable in the exercise of their professional judgment, including those procedures that may be unforeseen or not known to be needed at the time this consent is obtained. This consent shall also extend to the treatment of all conditions which may arise during the course of such procedures including those conditions which may arise during the course of such procedures including those conditions which may be unknown or unforeseen at the time this consent is obtained.
(B) I acknowledge and understand and duly evidence in writing by executing this form that under Georgia law I am entitled to receive the following information relative to the procedure(s) described in paragraph (A):
(1) A diagnosis of the condition requiring the procedure(s);
(2) The nature and purpose of the procedure(s);
(3) The material risks of the procedure(s);
(4) The likelihood of success of the procedure(s);
(5) The practical alternatives to such procedure(s);
(6) The prognosis if the procedure(s) is (are) rejected.
(C) I acknowledge that there are practical alternatives to the procedure (s) described in paragraph (A) which alternatives reasonably prudent physicians generally recognize and accept.
(D) I acknowledge and understand that this request for and consent to surgical or diagnostic services shall be valid for the responsible physician, all medical personnel under the direct supervision and control of the responsible physician, and for all other medical personnel otherwise involved in the course of treatment.

I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK QUESTIONS AND ANY QUESTIONS I HAVE ASKED HAVE BEEN ANSWERED OR EXPLAINED IN A SATISFACTORY MANNER.

BY SIGNING BELOW, I ACKNOWLEDGE I HAVE READ OR HAD IT READ OR EXPLAINED TO ME AND I UNDERSTAND THIS FORM AND I VOLUNTARILY CONSENT TO ALLOW DR. __________________OR ANY PHYSICIAN DESIGNATED OR SELECTED BY HIM OR HER AND ALL MEDICAL PERSONNEL UNDER THE DIRECT SUPERVISION AND CONTROL OF SUCH PHYSICIAN AND ALL OTHER PERSONNEL WHICH MAY OTHERWISE BE INVOLVED IN PERFORMING SUCH PROCEDURES TO PERFORM THE PROCEDURES DESCRIBED OR OTHERWISE REFERRED TO HEREIN AND I FULLY AND COMPLETELY WAIVE THE RIGHT TO BE INFORMED OF THE INFORMATION SPECIFIED IN PARAGRAPH (B) AND REQUEST THAT SUCH INFORMATION NOT BE DISCLOSED.

_____________________________________________

Witness

_____________________________________________

Signature of patient or other person authorized to sign