25 TAC §§601.2 - 601.5, 601.8
The Texas Medical Disclosure Panel (panel) proposes amendments
to §§601.2 - 601.5 and 601.8, concerning informed consent.
BACKGROUND AND PURPOSE
These amendments are proposed in accordance with the Texas Civil Practice
and Remedies Code, §74.102, which requires the panel to determine which
risks and hazards related to medical care and surgical procedures must be
disclosed by health care providers or physicians to their patients or persons
authorized to consent for their patients and to establish the general form
and substance of such disclosure. The sections cover procedures requiring
full disclosure of specific risks and hazards--list A, procedures requiring
no disclosure of specific risks and hazards--list B, disclosure and consent
form for medical and surgical procedures, disclosure and consent form for
radiation therapy, and disclosure and consent form for hysterectomy.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §601.2 adds procedures and risks and hazards
for the cardiovascular system and nervous system treatments and procedures.
The proposed amendment to §601.3 removes procedures relating to the nervous
system and radiology that the panel proposes be moved to §601.2. The
proposed amendments to §§601.4 and 601.5 add a Spanish language
version of the disclosure and consent form for medical and surgical procedures,
and the disclosure and consent form for radiation therapy. The proposed amendment
to §601.8 makes editorial corrections to the disclosure and consent for
hysterectomy form and corrects a difference between the English and Spanish
language versions of the form.
FISCAL NOTE
Cindy Bednar, Manager, Facility Licensing Group, Regulatory Licensing Unit,
Department of State Health Services, has determined that for each year of
the first five years the sections are in effect, there will be no fiscal implications
to state or local governments as a result of enforcing and administering the
sections as proposed.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Bednar has also determined that there are no anticipated economic costs
to small businesses, micro-businesses, or to persons who are required to comply
with the amendments as proposed because regulated facilities already have
an obligation to disclose risks and hazards related to the medical care and
surgical procedures. The amendments will not add additional costs. There will
be no impact on local employment.
PUBLIC BENEFIT
In addition, Ms. Bednar has also determined that for each year of the first
five years the amendments are in effect, the public benefit anticipated as
a result of enforcing or administering the amended sections will be the assurance
that the panel continues to monitor the risks and hazards related to medical
care and surgical procedures, which must be disclosed by health care providers
or physicians to their patients or persons authorized to consent for their
patients and the general form and substance of such disclosure.
REGULATORY ANALYSIS
The panel has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environment exposure and
that may adversely affect, in a material way, the economy, a sector of the
economy, productivity, competition, jobs, the environment or the public health
and safety of a state or a sector of the state. This proposal is not specifically
intended to protect the environment or reduce risks to human health from environment
exposure.
TAKINGS IMPACT ASSESSMENT
The panel has determined that the proposed amendments do not restrict or
limit an owner's right to his or her property that would otherwise exist in
the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to the Texas Medical Disclosure
Panel, Attention: Cindy Bednar, Manager, Facility Licensing Group, Regulatory
Licensing Unit, Department of State Health Services, 1100 West 49th Street,
Austin, Texas 78756, (512) 834-6646 or by e-mail to Cindy.Bednar@dshs.state.tx.us.
Comments will be accepted for 30 days following publication of the proposal
in the
Texas Register
.
STATUTORY AUTHORITY
The amendments are proposed under the Texas Civil Practice and Remedies
Code, §74.102, which provides the Texas Medical Disclosure Panel with
the authority to prepare lists of medical treatments and surgical procedures
that do and do not require disclosure by physicians and health care providers
of the possible risks and hazards and to prepare the form(s) for the treatments
and procedures which do require disclosure.
The amendments affect Texas Civil Practice and Remedies Code, §74.102.
§601.2.Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A.
(a)
(No change.)
(b)
Cardiovascular system. [
No procedures are assigned
at this time.
]
(1)
Cardiac.
(A)
Surgical.
(i)
Coronary artery bypass, valve replacement.
(I)
Acute myocardial infarction.
(II)
Hemorrhage.
(III)
Kidney failure.
(IV)
Stroke.
(V)
Sudden death.
(VI)
Infection of chest wall/chest cavity.
(VII)
Valve related delayed onset infection.
(ii)
Heart transplant.
(I)
Infection.
(II)
Rejection.
(III)
Death.
(B)
Non-Surgical--Coronary angioplasty, coronary
stent insertion, pacemaker insertion, AICD insertion, and cardioversion.
(i)
Acute myocardial infarction.
(ii)
Rupture of myocardium.
(iii)
Life threatening arrhythmias.
(iv)
Necessity for emergency open heart surgery.
(v)
Hemorrhage.
(vi)
Stroke.
(vii)
Sudden death.
(viii)
Device related delayed onset infection.
(C)
Diagnostic.
(i)
Cardiac catheterization.
(I)
Allergic sensitivity reaction to injected contrast
media.
(II)
Acute myocardial infarction.
(III)
Kidney damage from IV contrast medium.
(IV)
Arrhythmias.
(V)
Stroke.
(VI)
Injury to vessels that may require immediate
surgical intervention.
(ii)
Electrophysiologic studies.
(I)
Cardiac perforation.
(II)
Life threatening arrhythmias.
(III)
Injury to vessels that may require immediate
surgical intervention.
(iii)
Stress testing--Acute myocardial infarction.
(iv)
Transesophageal echocardiography --Esophageal
perforation.
(2)
Vascular.
(A)
Open surgical repair of aortic, subclavian,
and iliac, artery aneurysms or occlusions, and renal artery bypass.
(i)
Hemorrhage.
(ii)
Paraplegia.
(iii)
Kidney damage.
(iv)
Stroke.
(v)
Acute myocardial infarction.
(vi)
Infection of graft.
(B)
Endovascular stenting of any portion of the
aorta, iliac or carotid artery.
(i)
Hemorrhage.
(ii)
Injury to vessels that may require immediate
surgical intervention.
(iii)
Conversion of procedure to open procedure.
(iv)
Failure to deliver stent/endoluminal graft.
(v)
Stent migration.
(vi)
Paraplegia (for thoracic aorta procedures only).
(vii)
Vessel occlusion.
(viii)
Pseudo aneurysm.
(ix)
Irreversible kidney damage.
(x)
Impotence (for abdominal aorta and iliac artery
procedures only).
(xi)
Stroke (for carotid artery procedures only).
(xii)
Seizure (for carotid artery procedures only).
(C)
Vascular thrombolysis.
(i)
Hemorrhage.
(ii)
Embolus.
(iii)
Pulmonary complications.
(iv)
Shock.
(c) - (l)
(No change.)
(m)
Nervous system treatments and procedures.
(1)
Craniotomy
, craniectomy or cranioplasty
[
(craniectomy) for excision of brain tissue, tumor, vascular malformation and
cerebral revascularization
].
(A) - (D)
(No change.)
(E)
Cerebral spinal fluid leak
with potential for meningitis and severe headaches.
(F)
Meningitis.
(G)
Brain abscess.
(2)
Cranial nerve operations
[
Craniotomy (craniectomy)
for cranial nerve operation including neurectomy, avulsion, rhizotomy or neurolysis
].
(A)
(No change.)
(B)
Recurrence
,
[
or
] continuation
or worsening
of the condition that required this operation.
(C)
(No change.)
(D)
New or different pain.
(3)
Spine operation, including laminectomy, decompression,
fusion, internal fixation or procedures for nerve root or spinal cord compression;
diagnosis; pain; deformity; mechanical instability; injury; removal of tumor,
abscess or hematoma (excluding coccygeal operations).
(A)
(No change.)
(B)
Impaired muscle function
or paralysis
.
(C)
Incontinence
,
[
or
] impotence
or impaired bowel function
.
(D)
(No change.)
(E)
Recurrence
,
[
or
] continuation
or worsening
of the condition that required the operation.
(F)
(No change.)
(G)
Hemorrhage.
(4)
Peripheral nerve operation; nerve grafts, decompression,
transposition or tumor removal; neurorrhaphy, neurectomy or neurolysis.
(A) - (B)
(No change.)
(C)
Recurrence
, continuation or worsening
[
or persistence
] of the condition that required the operation.
(D)
(No change.)
[
(5)
Correction of cranial deformity.]
[
(A)
Loss of brain function.]
[
(B)
Seizures.]
[
(C)
Recurrence or continuation of the condition
that required this operation.]
(5)
[
(6)
] Transphenoidal hypophysectomy
or other pituitary gland operation.
(A)
Spinal fluid leak.
(B)
Necessity for hormone replacement.
(C)
Recurrence or continuation of the condition that required
this operation.
(D)
Nasal septal deformity or perforation.
(6)
[
(7)
] Cerebral spinal fluid shunting
procedure or revision.
(A)
Shunt obstruction
, migration
or infection.
(B)
Seizure disorder.
(C)
Recurrence or continuation of brain dysfunction.
(D)
Injury to internal organs.
(E)
Possible brain injury or hemorrhage.
(n) - (s)
(No change.)
§601.3.Procedures Requiring No Disclosure of Specific Risks and Hazards--List B.
(a) - (l)
(No change.)
(m)
Nervous system.
[
(1)
Cranioplasty.]
(1)
[
(2)
] Lumbar puncture.
(2)
[
(3)
] Closure of meningomyelocele.
(3)
[
(4)
] Ventriculostomy with or without
air ventriculogram.
(4)
[
(5)
] Cisternal puncture (diagnostic).
[
(6)
Craniectomy or craniotomy
for intracranial hematoma, abscess or penetrating injury.]
(5)
[
(7)
] Stereotactic surgery for dystonia.
(6)
[
(8)
] Insertion of skeletal tongs.
(7)
[
(9)
] Intravenous cut-down.
(8)
[
(10)
] Elevation of depressed skull
fracture.
(9)
[
(11)
] Cervical 1-2 puncture (diagnostic).
(n)
Radiology.
(1) - (32)
(No change.)
[
(33)
Pacemaker lead placement.]
(33)
[
(34)
] Arthrography.
(34)
[
(35)
] Percutaneous nephrostogram
and/or internal
stent
[
stint
] or external drainage of
the kidney.
(35)
[
(36)
] Percutaneous transhepatic
cholangiogram and/or internal
stent
[
stint
] or external
drainage of the liver.
(36)
[
(37)
] Percutaneous abscess drainage.
(o) - (p)
(No change.)
§601.4.Disclosure and Consent Form.
(a)
The Texas Medical Disclosure Panel adopts the following
form which shall be used by a physician or health care provider to inform
a patient or person authorized to consent for the patient of the possible
risks and hazards involved in the medical treatments and surgical procedures
named in the form. Except for the procedures shown in subsection (b) of this
section, the following form shall be used for the medical treatments and surgical
procedures described in §601.2 of this title (relating to Procedures
Requiring Full Disclosure of Specific Risks and Hazards--List A).
Providers
shall have the form available in both English and Spanish language versions.
Both versions are available from the Department of State Health Services.
[
Figure: 25 TAC §601.4(a)
]
(1)
English form.
Figure: 25 TAC §601.4(a)(1)
(2)
Spanish form.
Figure: 25 TAC §601.4(a)(2)
(b)
(No change.)
§601.5.Disclosure and Consent Form for Radiation Therapy.
The Texas Medical Disclosure Panel adopts the following form to be
used by a physician or health care provider to inform a patient or person
authorized to consent for a patient of the possible risks and hazards involved
in the radiation therapy named in the form. This form is to be used in lieu
of the general disclosure and consent form adopted in §601.4(a) of this
title (relating to Disclosure and Consent Form) for disclosure and consent
relating to only radiation therapy procedures. If a surgical or anesthetic
procedure is required in combination with a radiation therapy procedure, the
general disclosure and consent form as adopted in §601.4(a) of this title
and the form adopted in this section shall be used. The general disclosure
and consent form shall be used for the surgical or anesthetic procedure and
the radiation therapy disclosure and consent form shall be used for the radiation
therapy procedure.
Providers shall have the form available in both English
and Spanish language versions. Both versions are available from the Department
of State Health Services.
[
Figure: 25 TAC §601.5
]
(1)
English form.
Figure: 25 TAC §601.5(1)
(2)
Spanish form.
Figure: 25 TAC §601.5(2)
§601.8.Disclosure and Consent Form for Hysterectomy.
The Texas Medical Disclosure Panel adopts the following form which
shall be used to provide informed consent to a patient or person authorized
to consent for the patient of the possible risks and hazards involved in the
hysterectomy surgical procedure named in the form. This form is to be used
in lieu of the general disclosure and consent form adopted in §601.4(a)
of this title (relating to Disclosure and Consent Form) for disclosure and
consent relating to only hysterectomy procedures. Providers are required to
use the form to obtain consent for hysterectomies performed at least 90 days
following publication of this adopted section in the
Texas Register
. Providers shall have the form available in both English
and Spanish language
versions
. Both versions are available from
the [
Texas
] Department of State Health Services.
(1)
English form.
Figure: 25 TAC §601.8(1)
(2)
Spanish form.
Figure: 25 TAC §601.8(2)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on April 11, 2005.
TRD-200501493
Melba W.G. Swafford, M.D.
Chairperson
Texas Medical Disclosure Panel
Earliest possible date of adoption: May 22, 2005
For further information, please call: (512) 458-7236