25 TAC §601.2, §601.3
The Texas Medical Disclosure Panel (panel) proposes amendments
to §601.2 and §601.3, concerning informed consent. These amendments
are proposed in accordance with the Texas Civil Practice and Remedies Code, §74.102,
that 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, and procedures requiring no disclosure of specific risks and hazards--list
B.
The proposed amendment to §601.2 adds risks and hazards to the cardiovascular
system. The amendment to §601.3 deletes certain procedures that are proposed
for inclusion in §601.2.
Cindy Bednar, Facility Licensing Group, Regulatory Licensing Unit, has
determined that for each year of the first five years the amendments are in
effect, there will be no fiscal implications to state or local government
as a result of administering the amendments as proposed.
Cindy 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. There will
be no cost to micro-businesses, small 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
is no anticipated impact on local employment.
Comments on the proposal may be submitted to the Texas Medical Disclosure
Panel, Attention: Cindy Bednar, Facility Licensing Group, Regulatory Licensing
Unit, Department of State Health Services, 1100 West 49th Street, Austin,
Texas 78756, (512) 834-6646. Comments will be accepted for 30 days following
publication of the proposal in the
Texas Register
.
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 and iliac
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.
(C)
Vascular thrombolysis.
(i)
Hemorrhage.
(ii)
Embolus.
(iii)
Pulmonary complications.
(iv)
Shock.
(c) - (s)
(No change.)
§601.3.Procedures Requiring No Disclosure of Specific Risks and Hazards--List B.
(a) - (m)
(No change.)
(n)
Radiology.
(1) - (32)
(No change.)
[(33)
Pacemaker lead placement.]
(33)
[
(34)
] Arthrography.
(34)
[
(35)
] Percutaneous nephrostogram
and/or internal stint or external drainage of the kidney.
(35)
[
(36)
] Percutaneous transhepatic
cholangiogram and/or internal stint or external drainage of the liver.
(36)
[
(37)
] Percutaneous abscess drainage.
(o) - (p)
(No change.)
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 January 14, 2005.
TRD-200500219
Melba W.G. Swafford, M.D.
Chairperson
Texas Medical Disclosure Panel
Earliest possible date of adoption: March 6, 2005
For further information, please call: (512) 458-7236