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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

    (D) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).

    (E) Weakness, paralysis, loss of coordination.

    (F) Cerebrospinal fluid leak with potential for severe headaches.

    (G) Meningitis (infection of coverings of brain and spinal cord).

    (H) Brain abscess.

    (I) Persistent vegetative state (not able to communicate or interact with others).

    (J) Hydrocephalus (abnormal fluid buildup causing pressure in the brain).

    (K) Seizures (uncontrolled nerve activity).

    (L) Need for permanent breathing tube and/or permanent feeding tube.

  (2) Cranial nerve operations.

    (A) Weakness, numbness, impaired muscle function or paralysis.

    (B) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).

    (C) Seizures (uncontrolled nerve activity).

    (D) New or different pain.

    (E) Stroke (damage to brain resulting in loss of one or more functions).

    (F) Persistent vegetative state (not able to communicate or interact with others).

    (G) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).

    (H) Cerebrospinal fluid leak with potential for severe headaches.

    (I) Meningitis (infection of coverings of brain and spinal cord).

    (J) Need for prolonged nursing care.

    (K) Need for permanent breathing tube and/or permanent feeding tube.

  (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) Weakness, pain, numbness or clumsiness.

    (B) Impaired muscle function or paralysis.

    (C) Incontinence, impotence or impaired bowel function (loss of bowel/bladder control and/or sexual function).

    (D) Migration of implants (movement of implanted devices).

    (E) Failure of implants (breaking of implanted devices).

    (F) Adjacent level degeneration (breakdown of spine above and/or below the level treated).

    (G) Cerebrospinal fluid leak with potential for severe headaches.

    (H) Meningitis (infection of coverings of brain and spinal cord).

    (I) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).

    (J) Unstable spine (abnormal movement between bones and/or soft tissues of the spine).

  (4) Peripheral nerve operation; nerve grafts, decompression, transposition or tumor removal; neurorrhaphy, neurectomy or neurolysis.

    (A) Numbness.

    (B) Impaired muscle function.

    (C) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).

    (D) Continued, increased or different pain.

    (E) Weakness.

  (5) Transphenoidal hypophysectomy or other pituitary gland operation.

    (A) Cerebrospinal fluid leak with potential for severe headaches.

    (B) Necessity for hormone replacement.

    (C) Recurrence or continuation of the condition that required this operation.

    (D) Deformity or perforation of nasal septum (hole in wall between the right and left halves of the nose).

    (E) Facial nerve injury resulting in disfigurement (loss of nerve function controlling muscles in face).

    (F) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).

    (G) Stroke (damage to brain resulting in loss of one or more functions).

    (H) Persistent vegetative state (not able to communicate or interact with others).

    (I) Headaches.

  (6) Cerebrospinal fluid shunting procedure or revision.

    (A) Shunt obstruction (blockage of shunt/tubing causing it to stop draining adequately).

    (B) Malposition or migration of shunt/tubing (improper positioning or later movement of shunt/tubing causing it to stop draining adequately).

    (C) Seizures (uncontrolled nerve activity).

    (D) Recurrence or continuation of brain dysfunction.

    (E) Injury to internal organs of the chest or abdomen.

    (F) Brain injury.

    (G) Stroke (damage to brain resulting in loss of one or more functions).

    (H) Persistent vegetative state (not able to communicate or interact with others).

    (I) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).

    (J) Cerebrospinal fluid leak with potential for severe headaches.

    (K) Meningitis (infection of coverings of brain and spinal cord).

    (L) Need for prolonged nursing care.

    (M) Need for permanent breathing tube and/or permanent feeding tube.

  (7) Elevation of depressed skull fracture.

    (A) Loss of brain function such as memory and/or ability to speak.

    (B) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).

    (C) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).

    (D) Weakness, paralysis, loss of coordination.

    (E) Cerebrospinal fluid leak with potential for severe headaches.

    (F) Meningitis (infection of coverings of brain and spinal cord).

    (G) Brain abscess.

    (H) Persistent vegetative state (not able to communicate or interact with others).

    (I) Seizures (uncontrolled nerve activity).

    (J) Need for permanent breathing tube and/or permanent feeding tube.

(n) Radiology.

  (1) Splenoportography (needle injection of contrast media into the spleen).

    (A) All associated risks as listed under subsection (b)(2)(B) of this section.

    (B) Injury to the spleen requiring blood transfusion and/or removal of the spleen.

  (2) Chemoembolization.

    (A) All associated risks as listed under subsection (b)(2)(B) of this section.

    (B) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).

    (C) Injury to or failure of liver (or other organ in which tumor is located).

    (D) Risks of the chemotherapeutic agent(s) utilized.

    (E) Cholecystitis (inflammation of the gallbladder) (for liver or other upper GI embolizations).

    (F) Abscess (infected fluid collection) in the liver or other embolized organ requiring further intervention.

    (G) Biloma (collection of bile in or near the liver requiring drainage) (for liver embolizations).

  (3) Radioembolization.

    (A) All associated risks as listed under subsection (b)(2)(B) of this section.

    (B) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).

    (C) Injury to or failure of liver (or other organ in which tumor is located).

    (D) Radiation complications: pneumonitis (inflammation of lung) which is potentially fatal; inflammation of stomach, intestines, gallbladder, pancreas; stomach or intestinal ulcer; scarring of liver.

  (4) Thermal and other ablative techniques for treatment of tumors (for curative intent or palliation) including radiofrequency ablation, microwave ablation, cryoablation, and high intensity focused ultrasound (HIFU).

    (A) Injury to tumor-containing organ or adjacent organs/structures.

    (B) Injury to nearby nerves potentially resulting in temporary or chronic (continuing) pain and/or loss of use and/or feeling.

    (C) Failure to completely treat tumor.

  (5) TIPS (Transjugular Intrahepatic Portosystemic Shunt) and its variants such as DIPS (Direct Intrahepatic Portocaval Shunt).

    (A) All associated risks as listed under subsection (b)(2)(B) - (D) of this section.

    (B) Hepatic encephalopathy (confusion/decreased ability to think).

    (C) Liver failure or injury.

    (D) Gallbladder injury.

    (E) Hemorrhage (severe bleeding).

    (F) Recurrent ascites (fluid building up in abdomen) and/or bleeding.

    (G) Kidney failure.

    (H) Heart failure.

    (I) Death.

  (6) Myelography.

    (A) Chronic (continuing) pain.

    (B) Nerve injury with loss of use and/or feeling.

    (C) Transient (temporary) headache, nausea, and/or vomiting.

    (D) Numbness.

    (E) Seizure.

  (7) Percutaneous abscess/fluid collection drainage (percutaneous abscess/seroma/lymphocele drainage and/or sclerosis (inclusive of percutaneous, transgluteal, transrectal and transvaginal routes)).

    (A) Sepsis (infection in the blood stream), possibly resulting in shock (severe decrease in blood pressure).

    (B) Injury to nearby organs.

    (C) Hemorrhage (severe bleeding).

    (D) Infection of collection which was not previously infected, or additional infection of abscess.

  (8) Procedures utilizing prolonged fluoroscopy.

    (A) Skin injury (such as epilation (hair loss), burns, or ulcers).

    (B) Cataracts (for procedures in the region of the head).

(o) Respiratory system treatments and procedures.

  (1) Biopsy and/or excision of lesion of larynx, vocal cords, trachea.

    (A) Loss or change of voice.

    (B) Swallowing or breathing difficulties.

    (C) Perforation (hole) or fistula (connection) in esophagus (tube from throat to stomach).

  (2) Rhinoplasty or nasal reconstruction with or without septoplasty.

    (A) Deformity of skin, bone or cartilage.

    (B) Creation of new problems, such as perforation of the nasal septum (hole in wall between the right and left halves of the nose) or breathing difficulty.

  (3) Submucous resection of nasal septum or nasal septoplasty.

    (A) Persistence, recurrence or worsening of the obstruction.

    (B) Perforation of nasal septum (hole in wall between the right and left halves of the nose) with dryness and crusting.

    (C) External deformity of the nose.

  (4) Lung biopsy.

    (A) Pneumothorax (collapsed lung).

    (B) Hemothorax (blood in the chest around the lung).

  (5) Segmental resection of lung.

    (A) Hemothorax (blood in the chest around the lung).

    (B) Abscess (infected fluid collection) in chest.

    (C) Insertion of tube into space between lung and chest wall or repeat surgery.

    (D) Need for additional surgery.

  (6) Thoracotomy.

    (A) Hemothorax (blood in the chest around the lung).

    (B) Abscess (infected fluid collection) in chest.

    (C) Pneumothorax (collapsed lung).

    (D) Need for additional surgery.

  (7) Thoracotomy with drainage.

    (A) Hemothorax (blood in the chest around the lung).

    (B) Abscess (infected fluid collection) in chest.

    (C) Pneumothorax (collapsed lung).

    (D) Need for additional surgery.

  (8) Open tracheostomy.

    (A) Loss of voice.

    (B) Breathing difficulties.

    (C) Pneumothorax (collapsed lung).

    (D) Hemothorax (blood in the chest around the lung).

    (E) Scarring in trachea (windpipe).

    (F) Fistula (connection) between trachea into esophagus (tube from throat to stomach) or great vessels.

  (9) Respiratory tract/tracheobronchial balloon dilatation/stenting.

    (A) Stent migration (stent moves from position in which it was placed).

    (B) Pneumomediastinum (air enters the space around the airways including the space around the heart).

Cont'd...

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