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
|
