PART 7. TEXAS MEDICAL DISCLOSURE PANEL
CHAPTER 601. INFORMED CONSENT
The Texas Medical Disclosure Panel (Panel) adopts the repeal of Texas Administrative Code (TAC), Title 25, Part 7, Chapter 601, concerning Informed Consent, and replacement with new Chapter 601, concerning General. The repealed chapter consists of §§601.1 - 601.9. The new chapter consists of §601.1 and §601.2.
The repeal of §§601.1 - 601.9 and new §601.1 and §601.2 are adopted without changes to the proposed text as published in the July 28, 2023, issue of the Texas Register (48 TexReg 4081). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The repeals and new rules are adopted in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.
This project repeals current 25 TAC Chapter 601, Informed Consent, and replaces it in a nonsubstantive manner with multiple chapters in order to make the Panel's determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.
The new Chapter 601 contains the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel.
The new Chapter 602 lists each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 603 lists each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 604 contains general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules appear elsewhere in this issue of the Texas Register.
SECTION-BY-SECTION SUMMARY
The repeal of §§601.1 - 601.9 removes the rules from Chapter 601, concerning Informed Consent, and places them in new Chapters 601 - 604.
The new §601.1 outlines the purpose of the chapter, where the list of treatments and procedures requiring full disclosure by a physician or health care provider will be found, where the list of treatments and procedures requiring no disclosure by a physician or a health care provider will be found, and where the disclosure and consent forms adopted by the Panel will be found.
The new §601.2 provides an overview of the history of the procedures requiring full disclosure--List A and the procedures requiring no disclosure--List B prior to this rule project.
PUBLIC COMMENT
The 31-day public comment period ended August 28, 2023.
During this period, the Panel received comments from two commenters, representing the Texas Medical Association (TMA) and the Texas Society of Anesthesiologists (TSA). A summary of the comments and the Panel's responses follow.
Comment: The TMA thanked the Panel for its work on the revisions and recommended nonsubstantive changes to correct typographical and citation errors in new Chapters 602 and 604.
Response: The Panel acknowledges the comment and includes the changes in Chapters 602 and 604 published elsewhere in this issue of the Texas Register.
Comment: The TSA thanked the Panel and said it supports the efforts to convey the purpose of the Panel clearly and effectively to the public. The TSA participated in the review process and supports the version of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) that is proposed in §604.5 and was adopted by the Panel in April 2023.
Response: The Panel acknowledges the comment.
STATUTORY AUTHORITY
The repeals are authorized under Texas Civil Practice and Remedies Code §74.102, which created 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, and §74.103, which requires the Panel 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 forms for the treatments and procedures which do require disclosure.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on December 6, 2023.
TRD-202304583
Dr. Noah Appel
Panel Chairman
Texas Medical Disclosure Panel
Effective date: December 26, 2023
Proposal publication date: July 28, 2023
For further information, please call: (512) 438-2889
STATUTORY AUTHORITY
The new sections are authorized under Texas Civil Practice and Remedies Code §74.102, which created 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, and §74.103, which requires the Panel 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 forms for the treatments and procedures which do require disclosure.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on December 6, 2023.
TRD-202304584
Dr. Noah Appel
Panel Chairman
Texas Medical Disclosure Panel
Effective date: December 26, 2023
Proposal publication date: July 28, 2023
For further information, please call: (512) 438-2889
The Texas Medical Disclosure Panel (Panel) adopts new Texas Administrative Code (TAC), Title 25, Part 7, Chapter 602, concerning Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A. The new chapter consists of §§602.1 - 602.22.
New §§602.2, 602.7, 602.8, and 602.15 are adopted with changes to the proposed text as published in the July 28, 2023, issue of the Texas Register (48 TexReg 4085). These rules will be republished.
New §§602.1, 602.3 - 602.6, 602.9 - 602.14, and 602.16 - 602.22 are adopted without changes to the proposed text as published in the July 28, 2023, issue of the Texas Register (48 TexReg 4085). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
These new rules are adopted in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.
This project repeals current 25 TAC Chapter 601, Informed Consent, and replaces it in a nonsubstantive manner with multiple chapters in order to make the Panel's determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.
The new Chapter 601 contains the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 602 lists each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2.
The new Chapter 603 lists each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 604 contains general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules appear elsewhere in this issue of the Texas Register.
SECTION-BY-SECTION SUMMARY
The new §602.1, Anesthesia treatments and procedures, lists the anesthesia treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.2, Cardiovascular system treatments and procedures, lists the cardiovascular system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.3, Digestive system treatments and procedures, lists the digestive system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.4, Ear treatments and procedures, lists the ear treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.5, Endocrine system treatments and procedures, lists the endocrine system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.6, Eye treatments and procedures, lists the eye treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.7, Female genital system treatments and procedures, lists the female genital system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.8, Hematic and lymphatic system treatments and procedures, lists the hematic and lymphatic system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.9, Breast surgery (non-cosmetic) treatments and procedures, lists the breast surgery (non-cosmetic) treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.10, Male genital system treatments and procedures, lists the male genital system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.11, Maternity and related cases treatments and procedures, lists the maternity and related cases treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.12, Musculoskeletal system treatments and procedures, lists the musculoskeletal system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.13, Nervous system treatments and procedures, lists the nervous system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.14, Radiology treatments and procedures, lists the radiology treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.15, Respiratory system treatments and procedures, lists the respiratory system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.16, Urinary system treatments and procedures, lists the urinary system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.17, Psychiatric treatments and procedures, lists the psychiatric treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.18, Radiation therapy treatments and procedures, lists the radiation therapy treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §601.19, Laparoscopic, thoracoscopic and robotic surgery treatments and procedures, lists the laparoscopic, thoracoscopic and robotic surgery treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.20, Pain management treatments and procedures, lists the pain management treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.21, Dental surgery treatments and procedures, lists the dental surgery treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
The new §602.22, Plastic surgery and surgery of the integumentary system treatments and procedures, lists the plastic surgery and surgery of the integumentary system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
PUBLIC COMMENT
The 31-day public comment period ended August 28, 2023.
During this period, the Panel received comments from two commenters, representing the Texas Medical Association (TMA) and the Texas Society of Anesthesiologists (TSA). A summary of the comments and the Panel's responses follow.
Comment: The TMA thanked the Panel for its work on the revisions and recommended correcting citation errors at §602.2(b)(6)(E) and §602.7(b)(6), and typographical errors in the heading of §602.8 and at §602.15(i)(3). The TMA also made a recommendation regarding Chapter 604.
Response: The Panel revises these sections as suggested and addresses the Chapter 604 recommendation published elsewhere in this issue of the Texas Register.
Comment: The TSA thanked the panel and said it supports the efforts to convey the purpose of the Panel clearly and effectively to the public. TSA participated in the review process and supports the version of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) that is proposed in §604.5 and was adopted by the Panel in April 2023.
Response: The Panel acknowledges the comment.
STATUTORY AUTHORITY
The new sections are authorized under Texas Civil Practice and Remedies Code §74.102, which created 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, and §74.103, which requires the Panel 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 forms for the treatments and procedures which do require disclosure.
§602.2.Cardiovascular System Treatments and Procedures.
(a) Cardiac.
(1) Coronary artery bypass.
(A) Acute myocardial infarction (heart attack).
(B) Hemorrhage (severe bleeding).
(C) Kidney failure.
(D) Stroke.
(E) Sudden death.
(F) Infection of chest wall/chest cavity.
(2) Heart valve replacement by open surgery, structural heart surgery.
(A) Acute myocardial infarction (heart attack).
(B) Hemorrhage (severe bleeding).
(C) Kidney failure.
(D) Stroke.
(E) Sudden death.
(F) Infection of chest wall/chest cavity.
(G) Valve related delayed onset infection.
(H) Malfunction of new valve.
(I) Persistence of problem for which surgery was performed, including need for repeat surgery.
(3) Heart transplant.
(A) Infection.
(B) Rejection.
(C) Death.
(4) Coronary angiography (Injection of contrast material into arteries of the heart), coronary angioplasty (opening narrowing in heart vessel), and coronary stent insertion (placement of permanent tube into heart blood vessel to open it).
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(5) Percutaneous (through the skin) or minimally invasive heart valve insertion/replacement.
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Malfunction of new valve.
(K) Need for permanent pacemaker implantation.
(6) Left atrial appendage closure (closing of small pouch on left side of heart) - percutaneous (through the skin) or minimally invasive.
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Device embolization (device moves from intended location).
(K) Pericardial effusion (development of fluid in the sack around the heart) and cardiac tamponade (fluid around heart causing too much pressure for heart to pump properly).
(7) Patent foramen ovale/atrial septal defect/ventricular septal defect closure by percutaneous (through the skin) or minimally invasive procedure (closing of abnormal hole between the chambers of the heart).
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Atrial fibrillation (irregular heart rhythm).
(K) Pulmonary embolus (development of blood clot that travels to blood vessels in lungs).
(L) Device embolization (device moves from where it is placed).
(M) Cardiac perforation (creation of hole in wall of heart).
(8) Electrophysiology studies (exams of heart rhythm), arrhythmia ablation (procedure to control or stop abnormal heart rhythms).
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Rupture of myocardium/cardiac perforation (hole in wall of heart).
(K) Cause or worsening of arrhythmia (damage to heart electrical system causing abnormal heart rhythm), possibly requiring permanent pacemaker implantation, possibly life threatening.
(L) Pulmonary vein stenosis (narrowing of blood vessel going from lung to heart.
(9) Pacemaker insertion, AICD insertion (implanted device to shock the heart out of an abnormal rhythm).
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Rupture of myocardium/cardiac perforation (hole in wall of heart).
(K) Cause or worsening of arrhythmia (damage to heart electrical system causing abnormal heart rhythm), possibly requiring permanent pacemaker implantation, possibly life threatening.
(L) Device related delayed onset infection (infection related to the device that happens at some time after surgery).
(10) Electrical cardioversion (shocking the heart out of an abnormal rhythm).
(A) Heart arrhythmias (abnormal heart rhythm), possibly life threatening.
(B) Skin burns on chest.
(11) Stress testing.
(A) Acute myocardial infarction (heart attack).
(B) Heart arrhythmias (abnormal heart rhythm), possibly life threatening.
(12) Transesophageal echocardiography (ultrasound exam of the heart from inside the throat).
(A) Sore throat.
(B) Vocal cord damage.
(C) Esophageal perforation (hole or tear in tube from mouth to stomach).
(13) Circulatory assist devices (devices to help heart pump blood).
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy or other kidney injury (kidney damage due to the contrast agent used during the procedure or procedure itself).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Hemorrhage (severe bleeding) possibly leading to sudden death.
(K) Hemolysis (blood cells get broken apart).
(L) Right heart failure (poor functioning of the side of heart not assisted by device).
(M) Acquired von Willebrand syndrome (platelets do not work).
(N) Arrhythmia (irregular or abnormal heart rhythm).
(O) Cardiac or vascular injury or perforation (hole in heart or blood vessel).
(P) Limb ischemia (lack of blood flow or oxygen to limb that device placed through).
(Q) Device migration or malfunction.
(R) Exposure of device/wound break down with need for surgery to cover/reimplant.
(14) Extracorporeal Membrane Oxygenation (ECMO).
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy or other kidney injury (kidney damage due to the contrast agent used during the procedure or procedure itself).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) Thrombocytopenia (low platelets) or other coagulopathy (blood thinning).
(K) Vascular or cardiac perforation (hole in blood vessel or heart).
(L) Seizure.
(M) Device migration or malfunction.
(N) Ischemia to limb (lack of blood flow or oxygen to limb that device placed through).
(O) Thromboembolism (blood clots in blood vessels or heart and possibly traveling to blood vessels in lungs).
(b) Vascular.
(1) Open surgical repair of aortic, subclavian, iliac, or other artery aneurysms or occlusions, arterial or venous bypass or other vascular surgery.
(A) Hemorrhage (severe bleeding).
(B) Paraplegia (unable to move limbs) (for surgery involving the aorta or other blood vessels to the spine).
(C) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the procedure is being done.
(E) Stroke (for surgery involving blood vessels supplying the neck or head).
(F) Kidney damage.
(G) Myocardial infarction (heart attack).
(H) Infection of graft (material used to repair blood vessel).
(2) Angiography (inclusive of aortography, arteriography, venography) - Injection of contrast material into blood vessels.
(A) Injury to or occlusion (blocking) of artery which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the procedure is being done.
(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(3) Angioplasty (intravascular dilatation technique).
(A) 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 or drained by the vessel with resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the procedure is being done.
(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) 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.
(4) 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.
(A) 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 or drained by the vessel with resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the procedure is being done.
(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(J) 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.
(K) Change in procedure to open surgical procedure.
(L) Failure to place stent/endoluminal graft (stent with fabric covering it).
(M) Stent migration (stent moves from location in which it was placed).
(N) Impotence (difficulty with or inability to obtain penile erection) (for abdominal aorta and iliac artery procedures).
(5) Vascular thrombolysis (removal or dissolving of blood clots) - percutaneous (through the skin) (mechanical or chemical).
(A) 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 or drained by the vessel with resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the procedure is being done.
(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
(I) Kidney injury or failure which may be temporary or permanent (for procedures using certain mechanical thrombectomy devices).
(J) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(K) Increased risk of bleeding at or away from site of treatment (when using medications to dissolve clots).
(L) For arterial procedures: distal embolus (fragments of blood clot may travel and block other blood vessels with possible injury to the supplied tissue).
(M) 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).
(N) Need for emergency surgery.
(6) Angiography with occlusion techniques (including embolization and sclerosis) - therapeutic.
(A) For all embolizations/sclerosis:
(i) Injury to or occlusion (blocking) of blood vessel other than the one intended which may require immediate surgery or other intervention.
(ii) Hemorrhage (severe bleeding).
(iii) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).
(iv) Worsening of the condition for which the procedure is being done.
(v) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
(vi) Unintended thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(vii) 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).
(viii) Infection in the form of abscess (infected fluid collection) or septicemia (infection of blood stream).
(ix) Nontarget embolization (blocking of blood vessels other than those intended) which can result in injury to tissues supplied by those vessels.
(B) 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 subparagraph (A) of this paragraph:
(i) Stroke.
(ii) Seizure.
(iii) Paralysis (inability to move).
(iv) Inflammation or other injury of nerves (for procedures involving blood vessels supplying the spine).
(v) For studies of the blood vessels of the brain: contrast-related, temporary blindness or memory loss.
(C) For female pelvic arterial embolizations including uterine fibroid embolization, these risks in addition to those under subparagraph(A) of this paragraph:
(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.
(D) For male pelvic arterial embolizations, in addition to the risks under subparagraph (A) of this paragraph: impotence (difficulty with or inability to obtain penile erection).
(E) For embolizations of pulmonary arteriovenous fistulae/malformations, these risks in addition to those under subparagraph (A) of this paragraph:
(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)).
(F) For varicocele embolization, these risks in addition to those under subparagraph (A) of this paragraph:
(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).
(G) For ovarian vein embolization/pelvic congestion syndrome embolization: general angiography and embolization risks as listed in subparagraph (A) of this paragraph.
(H) For cases utilizing ethanol (alcohol) injection, in addition to the risks under subparagraph (A) of this paragraph: shock or severe lowering of blood pressure (when more than small volumes are utilized).
(I) For varicose vein treatments (with angiography) see paragraph (12) of this subsection.
(7) Mesenteric angiography with infusional therapy (Vasopressin) for gastrointestinal bleeding.
(A) 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 or drained by the vessel 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) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(G) 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).
(H) Antidiuretic hormone side effects of vasopressin (reduced urine output with disturbance of fluid balance in the body, rarely leading to swelling of the brain).
(8) Inferior vena caval filter insertion and removal.
(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Worsening of the condition for which the procedure is being done.
(D) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
(E) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere including caval thrombosis (clotting of main vein in abdomen and episodes of swelling of legs).
(F) Injury to the inferior vena cava (main vein in abdomen).
(G) Filter migration or fracture (filter could break and/or move from where it was placed).
(H) Risk of recurrent pulmonary embolus (continued risk of blood clots going to blood vessels in lungs despite filter).
(I) Inability to remove filter (for "optional"/retrievable filters).
(9) Pulmonary angiography.
(A) 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 or drained by the vessel 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) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.
(G) Cardiac arrhythmia (irregular heart rhythm) or cardiac arrest (heart stops beating).
(H) Cardiac injury/perforation (heart injury).
(I) Death.
(10) Percutaneous treatment of pseudoaneurysm (percutaneous thrombin injection through the skin versus compression).
(A) Thrombosis (clotting) of supplying vessel or branches in its territory.
(B) Allergic reaction to thrombin (agent used for direct injection).
(11) Vascular access - nontunneled catheters, tunneled catheters, implanted access.
(A) Pneumothorax (collapsed lung).
(B) Injury to blood vessel.
(C) Hemothorax/hemomediastinum (bleeding into the chest around the lungs or around the heart).
(D) Air embolism (passage of air into blood vessel and possibly to the heart and/or blood vessels entering the lungs).
(E) Vessel thrombosis (clotting of blood vessel).
(12) Varicose vein treatment (percutaneous (through the skin), via laser, radiofrequency ablation (RFA), chemical or other method) without angiography.
(A) Burns.
(B) Deep vein thrombosis (blood clots in deep veins).
(C) Hyperpigmentation (darkening of skin).
(D) Skin wound (ulcer).
(E) Telangiectatic matting (appearance of tiny blood vessels in treated area).
(F) Paresthesia and dysesthesia (numbness or tingling in the area or limb treated).
(G) Injury to blood vessel requiring additional procedure to treat.
§602.7.Female Genital System Treatments and Procedures.
(a) Hysterectomy (abdominal and vaginal).
(1) Uncontrollable leakage of urine.
(2) Injury to bladder.
(3) Injury to the tube (ureter) between the kidney and the bladder.
(4) Injury to the bowel and/or intestinal obstruction.
(5) Need to covert to abdominal incision.
(6) If laparoscopic surgery is utilized, include the following risks:
(A) Damage during introduction of trocar to adjacent intra-abdominal structures and organs (e.g., bowel, bladder, blood vessels, or nerves) and potential need for additional surgery.
(B) Trocar site complications (e.g., hematoma, bleeding, leakage of fluid, or hernia formation).
(C) Air embolus (bubble causing heart failure or stroke).
(D) Change during the procedure to an open procedure.
(E) If cancer is present, may increase the risk of the spread of cancer.
(b) All fallopian tube and ovarian surgery with or without hysterectomy, including removal and lysis of adhesions.
(1) Injury to the bowel and/or bladder.
(2) Sterility.
(3) Failure to obtain fertility (if applicable).
(4) Failure to obtain sterility (if applicable).
(5) Loss of ovarian functions or hormone production from ovary(ies).
(6) If performed with hysterectomy, all associated risks under subsection (a) of this section.
(7) For fallopian tube occlusion (for sterilization with or without hysterectomy), see subsection (n) of this section.
(c) Removing fibroids (uterine myomectomy).
(1) Injury to bladder.
(2) Sterility.
(3) Injury to the tube (ureter) between the kidney and the bladder.
(4) Injury to the bowel and/or intestinal obstruction.
(5) May need to convert to hysterectomy.
(6) If laparoscopic surgery is utilized, include the following risks:
(A) Damage during introduction of trocar to adjacent intra-abdominal structures and organs (e.g., bowel, bladder, blood vessels, or nerves) and potential need for additional surgery.
(B) Trocar site complications (e.g., hematoma, bleeding, leakage of fluid, or hernia formation).
(C) Air embolus (bubble causing heart failure or stroke).
(D) Change during the procedure to an open procedure.
(E) If cancer is present, may increase the risk of the spread of cancer.
(d) Uterine suspension.
(1) Uncontrollable leakage of urine.
(2) Injury to bladder.
(3) Injury to the tube (ureter) between the kidney and the bladder.
(4) Injury to the bowel and/or intestinal obstruction.
(e) Removal of the nerves to the uterus (presacral neurectomy).
(1) Uncontrollable leakage of urine.
(2) Injury to bladder.
(3) Injury to the tube (ureter) between the kidney and the bladder.
(4) Injury to the bowel and/or intestinal obstruction.
(5) Hemorrhage (severe bleeding).
(f) Removal of the cervix.
(1) Uncontrollable leakage of urine.
(2) Injury to bladder.
(3) Sterility.
(4) Injury to the tube (ureter) between the kidney and the bladder.
(5) Injury to the bowel and/or intestinal obstruction.
(6) Need to convert to abdominal incision.
(g) Repair of vaginal hernia (anterior and/or posterior colporrhaphy and/or enterocele repair).
(1) Uncontrollable leakage of urine.
(2) Injury to bladder.
(3) Sterility.
(4) Injury to the tube (ureter) between the kidney and the bladder.
(5) Injury to the bowel and/or intestinal obstruction.
(6) Mesh erosion (with damage to vagina and adjacent tissue).
(h) Abdominal suspension of the bladder (retropubic urethropexy).
(1) Uncontrollable leakage of urine.
(2) Injury to bladder.
(3) Injury to the tube (ureter) between the kidney and the bladder.
(4) Injury to the bowel and/or intestinal obstruction.
(i) Conization of cervix.
(1) Hemorrhage (severe bleeding) which may result in hysterectomy.
(2) Sterility.
(3) Injury to bladder.
(4) Injury to rectum.
(j) Dilation and curettage of uterus (diagnostic/therapeutic).
(1) Possible hysterectomy.
(2) Perforation (hole) created in the uterus.
(3) Sterility.
(4) Injury to bowel and/or bladder.
(5) Abdominal incision and operation to correct injury.
(k) Surgical abortion/dilation and curettage/dilation and evacuation.
(1) Possible hysterectomy.
(2) Perforation (hole) created in the uterus.
(3) Sterility.
(4) Injury to the bowel and/or bladder.
(5) Abdominal incision and operation to correct injury.
(6) Failure to remove all products of conception.
(l) Medical abortion/non-surgical.
(1) Hemorrhage with possible need for surgical intervention.
(2) Failure to remove all products of conception.
(3) Sterility.
(m) Selective salpingography and tubal reconstruction.
(1) Perforation (hole) created in the uterus or Fallopian tube.
(2) Future ectopic pregnancy (pregnancy outside of the uterus).
(3) Pelvic infection.
(n) Fallopian tube occlusion (for sterilization with or without hysterectomy).
(1) Perforation (hole) created in the uterus or Fallopian tube.
(2) Future ectopic pregnancy (pregnancy outside of the uterus).
(3) Pelvic infection.
(4) Failure to obtain sterility.
(o) Hysteroscopy.
(1) Perforation (hole) created in the uterus.
(2) Fluid overload/electrolyte imbalance.
(3) Possible hysterectomy.
(4) Abdominal incision to correct injury.
§602.8.Hematic and Lymphatic System Treatments and Procedures.
(a) Transfusion of blood and blood components.
(1) Serious infection including but not limited to Hepatitis and HIV which can lead to organ damage and permanent impairment.
(2) Transfusion related injury resulting in impairment of lungs, heart, liver, kidneys, and immune system.
(3) Severe allergic reaction, potentially fatal.
(b) Splenectomy.
(1) Susceptibility to infections and increased severity of infections.
(2) Increased immunization requirements.
§602.15.Respiratory System Treatments and Procedures.
(a) Biopsy and/or excision (removal) of lesion of larynx, vocal cords, trachea.
(1) Loss or change of voice.
(2) Swallowing or breathing difficulties.
(3) Perforation (hole) or fistula (connection) in esophagus (tube from throat to stomach).
(b) Rhinoplasty (surgery to change the shape of the nose) or nasal reconstruction with or without nasal septoplasty (surgical procedure to remove blockage in or straighten the bone and cartilage dividing the space between the two nostrils).
(1) Deformity of skin, bone or cartilage.
(2) 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.
(c) Submucous resection of nasal septum or nasal septoplasty (surgery to remove blockage in or straighten the bone and cartilage dividing the space between the two nostrils).
(1) Persistence, recurrence or worsening of the obstruction.
(2) Perforation of nasal septum (hole in the bone and/or cartilage dividing the space between the right and left halves of the nose) with dryness and crusting.
(3) External deformity of the nose.
(d) Sinus surgery/endoscopic sinus surgery.
(1) Spinal fluid leak.
(2) Visual loss or other eye injury.
(3) Numbness in front teeth and palate (top of mouth).
(4) Loss or reduction in sense of taste or smell.
(5) Recurrence of disease.
(6) Empty Nose Syndrome (sensation of nasal congestion, sensation of not being able to take in adequate air through nose).
(7) Injury to tear duct causing drainage of tears down the cheek.
(8) Brain injury and/or infection.
(9) Injury to nasal septum (the bone and cartilage dividing the space between the two nostrils).
(10) Nasal obstruction.
(e) Lung biopsy (removal of small piece of tissue from inside of lung).
(1) Air leak with pneumothorax (leak of air from lung to inside of chest causing the lung to collapse) with need for insertion of chest tube or repeat surgery.
(2) Hemothorax (blood in the chest around the lung) possibly requiring additional procedures.
(3) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).
(f) Segmental resection of lung (removal of a portion of a lung).
(1) Hemothorax (blood in the chest around the lung).
(2) Abscess (infected fluid collection) in chest.
(3) Air leak with pneumothorax (leak of air from lung inside of chest causing the lung to collapse) with need for insertion of chest drainage tube into space between lung and chest wall or repeat surgery.
(4) Need for additional surgery.
(g) Thoracotomy (surgery to reach the inside of the chest).
(1) Hemothorax (blood in the chest around the lung).
(2) Abscess (infected fluid collection) in chest.
(3) Air leak with pneumothorax (leak of air from lung inside of chest causing the lung to collapse) with need for insertion of chest drainage tube into space between lung and chest wall or repeat surgery.
(4) Need for additional surgery.
(h) VATS - video-assisted thoracoscopic surgery (camera-assisted surgery to reach the inside of the chest through small incisions).
(1) Hemothorax (blood in the chest around the lung).
(2) Abscess (infected fluid collection) in chest.
(3) Air leak with pneumothorax (leak of air from lung inside of chest causing the lung to collapse) with need for insertion of chest drainage tube into space between lung and chest wall or repeat surgery.
(4) Need for additional surgery.
(5) Need to convert to open surgery.
(i) Percutaneous (puncture through the skin instead of incision) or Open (surgical incision) tracheostomy.
(1) Loss of voice.
(2) Breathing difficulties.
(3) Pneumothorax (collapsed lung) with need for insertion of chest tube.
(4) Hemothorax (blood in the chest around the lung).
(5) Scarring in trachea (windpipe).
(6) Fistula (connection) between trachea into esophagus (tube from throat to stomach) or great vessels.
(7) Bronchospasm (constriction of the airways leading to trouble breathing).
(8) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).
(j) Bronchoscopy (insertion of a camera into the airways of the neck and chest).
(1) Mucosal injury (damage to lining of airways) including perforation (hole in the airway).
(2) Pneumothorax (collapsed lung) with need for insertion of chest tube.
(3) Pneumomediastinum (air enters the space around the airways including the space around the heart).
(4) Injury to vocal cords, laryngospasm (irritation/spasm of the vocal cords) or laryngeal edema (swelling of the vocal cords).
(5) Bronchospasm (constriction of the airways leading to trouble breathing).
(6) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).
(k) Endobronchial valve placement (device inserted into airways in the lung that controls air movement into and out of abnormal portions of a lung).
(1) Mucosal injury (damage to lining of airways) including perforation (hole in the airway).
(2) Pneumothorax (collapsed lung) with need for insertion of chest tube.
(3) Pneumomediastinum (air enters the space around the airways including the space around the heart).
(4) Injury to vocal cords, laryngospasm (irritation/spasm of the vocal cords) or laryngeal edema (swelling of the vocal cords).
(5) Migration (movement) of the stent from its original position.
(6) Airway blockage, potentially life threatening.
(7) Stent blockage.
(8) Worsening of chronic obstructive pulmonary disease (worsening of emphysema).
(9) Respiratory failure (need for breathing tube placement with ventilator support).
(10) Bronchospasm (constriction of the airways leading to trouble breathing).
(11) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).
(12) Recurrent infections.
(l) Endobronchial balloon dilatation with or without stent placement (placement of tube to keep airway open).
(1) Bronchial rupture (tearing of the airway) with need for additional surgery.
(2) Pneumothorax (collapsed lung) with need for insertion of chest tube.
(3) Pneumomediastinum (air enters the space around the airways including the space around the heart).
(4) Injury to vocal cords, laryngospasm (irritation/spasm of the vocal cords) or laryngeal edema (swelling of the vocal cords).
(5) Migration (movement) of the stent from its original position.
(6) Airway blockage, potentially life threatening.
(7) Stent blockage.
(8) Stent fracture (broken stent).
(9) Recurrent infections.
(10) Stent erosion into adjacent structures (stent wears a hole through the airway and injures nearby tissues).
(11) Hemoptysis (coughing up blood which can result in respiratory distress and the need to be placed on a ventilator or breathing machine and oxygen).
(m) Mediastinoscopy (insertion of a camera into the space behind the breastbone and between the lungs) with or without biopsy (removal of tissue).
(1) Hemorrhage (severe bleeding) requiring open surgery.
(2) Nerve injury causing vocal cord paralysis or poor function.
(3) Pneumothorax (collapsed lung).
(4) Tracheal injury (damage to the airway/windpipe).
(n) Pleurodesis (procedure to prevent fluid build-up in space between the lung and chest wall).
(1) Respiratory failure (need for breathing tube placement).
(2) Empyema (infection/pus in the space around the lung).
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on December 6, 2023.
TRD-202304585
Dr. Noah Appel
Panel Chairman
Texas Medical Disclosure Panel
Effective date: December 26, 2023
Proposal publication date: July 28, 2023
For further information, please call: (512) 438-2889
The Texas Medical Disclosure Panel (Panel) adopts new Texas Administrative Code (TAC), Title 25, Part 7, Chapter 603, concerning Procedures Requiring No Disclosure Of Specific Risks And Hazards--List B. The new chapter consists of §§603.1 - 603.21.
New §§603.1 - 603.21 are adopted without changes to the proposed text as published in the July 28, 2023, issue of the Texas Register (48 TexReg 4109). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
These rule repeals and new rules are adopted in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.
This project repeals current 25 TAC Chapter 601, Informed Consent, and replaces it in a nonsubstantive manner with multiple chapters in order to make the Panel's determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.
The new Chapter 601 contains the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 602 lists each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 603 lists each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3.
The new Chapter 604 contains general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules appear elsewhere in this issue of the Texas Register.
SECTION-BY-SECTION SUMMARY
The new §603.1, Anesthesia treatments and procedures, lists the anesthesia treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.2, Cardiovascular system treatments and procedures, lists the cardiovascular system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.3, Digestive system treatments and procedures, lists the digestive system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.4, Ear treatments and procedures, lists the ear treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.5, Endocrine system treatments and procedures, lists the endocrine system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.6, Eye treatments and procedures, lists the eye treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.7, Female genital system treatments and procedures, lists the female genital system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.8, Hematic and lymphatic system treatments and procedures, lists the hematic and lymphatic system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.9, Breast surgery (non-cosmetic) treatments and procedures, lists the breast surgery (non-cosmetic) treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.10, Male genital system treatments and procedures, lists the male genital system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.11, Maternity and related cases treatments and procedures, lists the maternity and related cases treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.12, Musculoskeletal system treatments and procedures, lists the musculoskeletal system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.13, Nervous system treatments and procedures, lists the nervous system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.14, Radiology treatments and procedures, lists the radiology treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.15, Respiratory system treatments and procedures, lists the respiratory system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.16, Urinary system treatments and procedures, lists the urinary system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.17, Psychiatric treatments and procedures, lists the psychiatric treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.18, Radiation treatments and procedures, lists the radiation treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.19, Laparoscopic/Thoracoscopic surgery treatments and procedures, lists the laparoscopic/thoracoscopic surgery treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.20, Pain management treatments and procedures, lists the pain management treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
The new §603.21, Plastic surgery and surgery of the integumentary system treatments and procedures, lists the plastic surgery and surgery of the integumentary system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
PUBLIC COMMENT
The 31-day public comment period ended August 28, 2023.
During this period, the Panel received comments from two commenters, representing the Texas Medical Association (TMA) and the Texas Society of Anesthesiologists (TSA). A summary of the comments and the Panel's responses follow.
Comment: The TMA thanked the Panel for its work on the revisions and recommended nonsubstantive changes to correct typographical and citation errors in new Chapters 602 and 604.
Response: The Panel acknowledges the comment and addresses the changes in Chapters 602 and 604 published elsewhere in this issue of the Texas Register.
Comment: The TSA thanked the Panel and said it supports the efforts to convey the purpose of the Panel clearly and effectively to the public. TSA participated in the review process and supports the version of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) adopted by the Panel in April 2023.
Response: The Panel acknowledges the comment.
STATUTORY AUTHORITY
The new sections are authorized under Texas Civil Practice and Remedies Code §74.102, which created 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, and §74.103, which requires the Panel 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 forms for the treatments and procedures which do require disclosure.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on December 6, 2023.
TRD-202304586
Dr. Noah Appel
Panel Chairman
Texas Medical Disclosure Panel
Effective date: December 26, 2023
Proposal publication date: July 28, 2023
For further information, please call: (512) 438-2889
The Texas Medical Disclosure Panel (Panel) adopts new Texas Administrative Code (TAC), Title 25, Part 7, Chapter 604, concerning Disclosure Forms. The new chapter consists of §§604.1 - 604.5.
New §604.2 is adopted with changes to the proposed text as published in the July 28, 2023, issue of the Texas Register (48 TexReg 4113). This rule will be republished.
New §§604.1, and 604.3 - 604.5 are adopted without changes to the proposed text as published in the July 28, 2023, issue of the Texas Register (48 TexReg 4113). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
These rule repeals and new rules are adopted in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.
This project repeals current 25 TAC Chapter 601, Informed Consent, and replaces it in a nonsubstantive manner with multiple chapters in order to make the Panel's determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.
The new Chapter 601 contains the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 602 lists each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 603 lists each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules appear elsewhere in this issue of the Texas Register.
The new Chapter 604 contains general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms.
SECTION-BY-SECTION SUMMARY
The new §604.1, Disclosure and Consent Form, lists the disclosure and consent forms that the Panel has determined are required to disclose risks and hazards associated with the procedures listed in Chapters 602 and 603.
The new §604.2, Disclosure and Consent Form for Radiation Therapy, lists the disclosure and/or consent forms that the Panel has determined are required to disclose risks and hazards associated with radiation therapy procedures.
The new §604.3, Informed Consent for Electroconvulsive Therapy, sets out disclosure requirements and options for electroconvulsive therapy.
The new §604.4, Disclosure and Consent Form for Hysterectomy, lists the disclosure and/or consent forms that the Panel has determined are required to disclose risks and hazards associated with hysterectomy procedures.
The new §604.5, Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia), lists the disclosure and/or consent forms that the Panel has determined are required to disclose risks and hazards associated with anesthesia and/or perioperative pain management (analgesia) procedures.
PUBLIC COMMENT
The 31-day public comment period ended August 28, 2023.
During this period, the Panel received comments from two commenters, representing the Texas Medical Association (TMA) and the Texas Society of Anesthesiologists (TSA). A summary of the comments and the Panel's responses follow.
Comment: The TMA thanked the Panel for its work on the revisions and recommended nonsubstantive changes to correct typographical and citation errors in new Chapters 602 and recommended deleting the phrase "or early and late reactions" on page 2 of the Disclosure and Consent Form for Radiation Therapy under proposed §604.2.
Response: The Panel revises page 2 of the form to read "risk of early and late reactions" (instead of "risk or early and late reactions") for clarity and addresses the Chapter 602 suggestions published elsewhere in this issue of the Texas Register.
Comment: The TSA thanked the Panel and said it supports the efforts to convey the purpose of the Panel clearly and effectively to the public. TSA participated in the review process and supports the version of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) adopted by the Panel in April 2023.
Response: The Panel acknowledges the comment.
STATUTORY AUTHORITY
The new sections are authorized under Texas Civil Practice and Remedies Code §74.102, which created 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, and §74.103, which requires the Panel 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 forms for the treatments and procedures which do require disclosure.
§604.2.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 §604.1(a) of this chapter (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 §604.1(a) of this chapter 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 Health and Human Services Commission.
(1) English form.
Figure: 25 TAC §604.2(1) (.pdf)
(2) Spanish form.
Figure: 25 TAC §604.2(2) (.pdf)
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on December 6, 2023.
TRD-202304588
Dr. Noah Appel
Panel Chairman
Texas Medical Disclosure Panel
Effective date: December 26, 2023
Proposal publication date: July 28, 2023
For further information, please call: (512) 438-2889