Chapter 360-14 INFORMED CONSENT
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.
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. |
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. |
| (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:
| (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. |
|
| (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. |
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. |
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
|
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
|
