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TITLE 25HEALTH SERVICES
PART 7TEXAS MEDICAL DISCLOSURE PANEL
CHAPTER 601INFORMED CONSENT
RULE §601.2Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A

(a) Anesthesia.

  (1) Epidural.

    (A) Nerve damage.

    (B) Persistent back pain.

    (C) Headache.

    (D) Bleeding/epidural hematoma.

    (E) Infection.

    (F) Medical necessity to convert to general anesthesia.

    (G) Brain damage.

    (H) Chronic pain.

  (2) General.

    (A) Permanent organ damage.

    (B) Memory dysfunction/memory loss.

    (C) Injury to vocal cords, teeth, lips, eyes.

    (D) Awareness during the procedure.

    (E) Brain damage.

  (3) Spinal.

    (A) Nerve damage.

    (B) Persistent back pain.

    (C) Bleeding/epidural hematoma.

    (D) Infection.

    (E) Medical necessity to convert to general anesthesia.

    (F) Brain damage.

    (G) Headache.

    (H) Chronic pain.

  (4) Regional block.

    (A) Nerve damage.

    (B) Persistent pain.

    (C) Bleeding/hematoma.

    (D) Infection.

    (E) Medical necessity to convert to general anesthesia.

    (F) Brain damage.

  (5) Monitored Anesthesia Care (MAC) (conscious sedation).

    (A) Permanent organ damage.

    (B) Memory dysfunction/memory loss.

    (C) Medical necessity to convert to general anesthesia.

    (D) Brain damage.

(b) Cardiovascular system.

  (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) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Acute myocardial infarction (heart attack).

      (iii) Rupture of myocardium (hole in wall of heart).

      (iv) Life threatening arrhythmias (irregular heart rhythm).

      (v) Need for emergency open heart surgery.

      (vi) Sudden death.

      (vii) Device related delayed onset infection (infection related to the device that happens sometime after surgery).

    (C) Diagnostic.

      (i) Cardiac catheterization.

        (I) All associated risks as listed under paragraph (2)(B) of this subsection.

        (II) Acute myocardial infarction (heart attack).

        (III) Contrast nephropathy (injury to kidney function due to use of contrast material during procedure).

        (IV) Heart arrhythmias (irregular heart rhythm), possibly life threatening.

        (V) Need for emergency open heart surgery.

      (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) Angiography (inclusive of aortography, arteriography, venography) - Injection of contrast material into blood vessels.

      (i) Injury to or occlusion (blocking) of artery which may require immediate surgery or other intervention.

      (ii) Hemorrhage (severe bleeding).

      (iii) Damage to parts of the body supplied by the artery with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).

      (vi) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).

      (vii) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

    (C) Angioplasty (intravascular dilatation technique).

      (i) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Failure of procedure or injury to blood vessel requiring stent (small, permanent tube placed in blood vessel to keep it open) placement or open surgery.

    (D) Endovascular stenting (placement of permanent tube into blood vessel to open it) of any portion of the aorta, iliac or carotid artery or other (peripheral) arteries or veins.

      (i) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Change in procedure to open surgical procedure.

      (iii) Failure to place stent/endoluminal graft (stent with fabric covering it).

      (iv) Stent migration (stent moves from location in which it was placed).

      (v) Vessel occlusion (blocking).

      (vi) Impotence (difficulty with or inability to obtain penile erection) (for abdominal aorta and iliac artery procedures).

    (E) Vascular thrombolysis (removal or dissolving of blood clots) - percutaneous (mechanical or chemical).

      (i) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Increased risk of bleeding at or away from site of treatment (when using medications to dissolve clots).

      (iii) For arterial procedures: distal embolus (fragments of blood clot may travel and block other blood vessels with possible injury to the supplied tissue).

      (iv) For venous procedures: pulmonary embolus (fragments of blood clot may travel to the blood vessels in the lungs and cause breathing problems or if severe could be life threatening).

      (v) Kidney injury or failure which may be temporary or permanent (for procedures using certain mechanical thrombectomy devices).

      (vi) Need for emergency surgery.

    (F) Angiography with occlusion techniques (including embolization and sclerosis) - therapeutic.

      (i) For all embolizations.

        (I) Angiography risks (inclusive of aortography, arteriography, venography) - injection of contrast material into blood vessels.

          (-a-) Unintended injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.

          (-b-) Hemorrhage (severe bleeding).

          (-c-) Damage to parts of the body supplied by the artery with resulting loss of use or amputation (removal of body part).

          (-d-) Worsening of the condition for which the procedure is being done.

          (-e-) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

          (-f-) Unintended thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

        (II) Loss or injury to body parts with potential need for surgery, including death of overlying skin for sclerotherapy/treatment of superficial lesions/vessels and nerve injury with associated pain, numbness or tingling or paralysis (inability to move).

        (III) Infection in the form of abscess (infected fluid collection) or septicemia (infection of blood stream).

        (IV) Nontarget embolization (blocking of blood vessels other than those intended) which can result in injury to tissues supplied by those vessels.

      (ii) For procedures involving the thoracic aorta and/or vessels supplying the brain, spinal cord, head, neck or arms, these risks in addition to those under clause (i) of this subparagraph:

        (I) Stroke.

        (II) Seizure.

        (III) Paralysis (inability to move).

        (IV) Inflammation or other injury of nerves.

        (V) For studies of the blood vessels of the brain: contrast-related, temporary blindness or memory loss.

      (iii) For female pelvic arterial embolizations including uterine fibroid embolization, these risks in addition to those under clause (i) of this subparagraph.

        (I) Premature menopause with resulting sterility.

        (II) Injury to or infection involving the uterus which might necessitate hysterectomy (removal of the uterus) with resulting sterility.

        (III) After fibroid embolization: prolonged vaginal discharge.

        (IV) After fibroid embolization: expulsion/delayed expulsion of fibroid tissue possibly requiring a procedure to deliver/remove the tissue.

      (iv) For male pelvic arterial embolizations, in addition to the risks under clause (i) of this subparagraph: impotence (difficulty with or inability to obtain penile erection).

      (v) For embolizations of pulmonary arteriovenous fistulae/malformations, these risks in addition to those under clause (i) of this subparagraph.

        (I) New or worsening pulmonary hypertension (high blood pressure in the lung blood vessels).

        (II) Paradoxical embolization (passage of air or an occluding device beyond the fistula/malformation and into the arterial circulation) causing blockage of blood flow to tissues supplied by the receiving artery and damage to tissues served (for example the blood vessels supplying the heart (which could cause chest pain and/or heart attack) or brain (which could cause stroke, paralysis (inability to move) or other neurological injury)).

      (vi) For varicocele embolization, these risks in addition to those under clause (i) of this subparagraph.

        (I) Phlebitis/inflammation of veins draining the testicles leading to decreased size and possibly decreased function of affected testis and sterility (if both sides performed).

        (II) Nerve injury (thigh numbness or tingling).

      (vii) For ovarian vein embolization/pelvic congestion syndrome embolization: general angiography and embolization risks as listed in clause (i) of this subparagraph.

      (viii) For cases utilizing ethanol (alcohol) injection, in addition to the risks under clause (i) of this subparagraph: shock or severe lowering of blood pressure.

      (ix) For varicose vein treatments (with angiography) see subparagraph (L) of this paragraph.

    (G) Mesenteric angiography with infusional therapy (Vasopressin) for gastrointestinal bleeding.

      (i) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Ischemia/infarction of supplied or distant vascular beds (reduction in blood flow causing lack of oxygen with injury or death of tissues supplied by the treated vessel or tissues supplied by blood vessels away from the treated site including heart, brain, bowel, extremities).

      (iii) Antidiuretic hormone side effects of vasopressin (reduced urine output with disturbance of fluid balance in the body, rarely leading to swelling of the brain).

    (H) Inferior vena caval filter insertion and removal.

      (i) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Injury to the inferior vena cava (main vein in the abdomen).

      (iii) Filter migration or fracture (filter could break and/or move from where it was placed).

      (iv) Caval thrombosis (clotting of the main vein in the abdomen and episodes of swelling of legs).

      (v) Risk of recurrent pulmonary embolus (continued risk of blood clots going to blood vessels in the lungs despite filter).

      (vi) Inability to remove filter (for "optional"/retrievable filters).

    (I) Pulmonary angiography.

Cont'd...

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