1. (a) Anesthesia.

   1. (1) Epidural.

      1. (A) Persistent back pain.
      2. (B) Bleeding/epidural hematoma.
      3. (C) Infection.
      4. (D) Potential to convert to a general anesthetic if the block fails or the procedure outlasts the block.
      5. (E) Brain damage.

   2. (2) General.

      1. (A) Permanent organ damage.
      2. (B) Memory dysfunction/memory loss.

   3. (3) Spinal.

      1. (A) Nerve damage.
      2. (B) Persistent back pain.
      3. (C) Bleeding/epidural hemotoma.
      4. (D) Infection.
      5. (E) Potential to convert to a general anesthetic if the block fails or the procedure outlasts the block.
      6. (F) Brain damage.

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

      1. (A) Permanent organ damage.
      2. (B) Memory dysfunction/memory loss.
      3. (C) Potential to convert to a general anesthetic if the sedation is not adequate.

2. (b) Cardiovascular system.

   1. (1) Cardiac.

      1. (A) Surgical.

         1. (i) Coronary artery bypass, valve replacement.

            1. (I) Acute myocardial infarction.
            2. (II) Hemorrhage.
            3. (III) Kidney failure.
            4. (IV) Stroke.
            5. (V) Sudden death.
            6. (VI) Infection of chest wall/chest cavity.
            7. (VII) Valve related delayed onset infection.

         2. (ii) Heart transplant.

            1. (I) Infection.
            2. (II) Rejection.
            3. (III) Death.

      2. (B) Non-Surgical--Coronary angioplasty, coronary stent insertion, pacemaker insertion, AICD insertion, and cardioversion.

         1. (i) All associated risks as listed under paragraph (2)(B) of this subsection.
         2. (ii) Acute myocardial infarction (heart attack).
         3. (iii) Rupture of myocardium (hole in wall of heart).
         4. (iv) Life threatening arrhythmias (irregular heart rhythm).
         5. (v) Need for emergency open heart surgery.
         6. (vi) Sudden death.
         7. (vii) Device related delayed onset infection (infection related to the device that happens sometime after surgery).

      3. (C) Diagnostic.

         1. (i) Cardiac catheterization.

            1. (I) All associated risks as listed under paragraph (2)(B) of this subsection.
            2. (II) Acute myocardial infarction (heart attack).
            3. (III) Contrast nephropathy (injury to kidney function due to use of contrast material during procedure).
            4. (IV) Heart arrhythmias (irregular heart rhythm), possibly life threatening.
            5. (V) Need for emergency open heart surgery.

         2. (ii) Electrophysiologic studies.

            1. (I) Cardiac perforation.
            2. (II) Life threatening arrhythmias.
            3. (III) Injury to vessels that may require immediate surgical intervention.
         3. (iii) Stress testing--Acute myocardial infarction.
         4. (iv) Transesophageal echocardiography--Esophageal perforation.

   2. (2) Vascular.

      1. (A) Open surgical repair of aortic, subclavian, and iliac, artery aneurysms or occlusions, and renal artery bypass.

         1. (i) Hemorrhage.
         2. (ii) Paraplegia.
         3. (iii) Kidney damage.
         4. (iv) Stroke.
         5. (v) Acute myocardial infarction.
         6. (vi) Infection of graft.

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

         1. (i) Injury to or occlusion (blocking) of artery which may require immediate surgery or other intervention.
         2. (ii) Hemorrhage (severe bleeding).
         3. (iii) Damage to parts of the body supplied by the artery with resulting loss of use or amputation (removal of body part).
         4. (iv) Worsening of the condition for which the procedure is being done.
         5. (v) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).
         6. (vi) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).
         7. (vii) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).
         8. (viii) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).
         9. (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      3. (C) Angioplasty (intravascular dilatation technique).

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

      4. (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.

         1. (i) All associated risks as listed under paragraph (2)(B) of this subsection.
         2. (ii) Change in procedure to open surgical procedure.
         3. (iii) Failure to place stent/endoluminal graft (stent with fabric covering it).
         4. (iv) Stent migration (stent moves from location in which it was placed).
         5. (v) Vessel occlusion (blocking).
         6. (vi) Impotence (difficulty with or inability to obtain penile erection) (for abdominal aorta and iliac artery procedures).

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

         1. (i) All associated risks as listed under paragraph (2)(B) of this subsection.
         2. (ii) Increased risk of bleeding at or away from site of treatment (when using medications to dissolve clots).
         3. (iii) For arterial procedures: distal embolus (fragments of blood clot may travel and block other blood vessels with possible injury to the supplied tissue).
         4. (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).
         5. (v) Kidney injury or failure which may be temporary or permanent (for procedures using certain mechanical thrombectomy devices).
         6. (vi) Need for emergency surgery.

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

         1. (i) For all embolizations.

            1. (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.

            2. (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).
            3. (III) Infection in the form of abscess (infected fluid collection) or septicemia (infection of blood stream).
            4. (IV) Nontarget embolization (blocking of blood vessels other than those intended) which can result in injury to tissues supplied by those vessels.

         2. (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:

            1. (I) Stroke.
            2. (II) Seizure.
            3. (III) Paralysis (inability to move).
            4. (IV) Inflammation or other injury of nerves.
            5. (V) For studies of the blood vessels of the brain: contrast-related, temporary blindness or memory loss.

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

            1. (I) Premature menopause with resulting sterility.
            2. (II) Injury to or infection involving the uterus which might necessitate hysterectomy (removal of the uterus) with resulting sterility.
            3. (III) After fibroid embolization: prolonged vaginal discharge.
            4. (IV) After fibroid embolization: expulsion/delayed expulsion of fibroid tissue possibly requiring a procedure to deliver/remove the tissue.
         4. (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).

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

            1. (I) New or worsening pulmonary hypertension (high blood pressure in the lung blood vessels).
            2. (II) Paradoxical embolizations (passage of air or an occluding divide 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)).

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

            1. (I) Phlebitis/inflammation of veins draining the testicles leading to decreased size and possibly decreased function or affected testis and sterility (if both sides performed).
            2. (II) Nerve injury (thigh numbness or tingling).
         7. (vii) For ovarian vein embolization/pelvic congestion syndrome embolization: general angiography and embolization risks as listed in clause (i) of this subparagraph.
         8. (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.)
         9. (ix) For varicose vein treatments (with angiography) see subparagraph (L) of this paragraph.

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

         1. (i) All associated risks as listed under paragraph (2)(B) of this subsection.
         2. (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).
         3. (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).

      8. (H) Inferior vena caval filter insertion and removal.

         1. (i) All associated risks as listed under paragraph (2)(B) of this subsection.
         2. (ii) Injury to the inferior vena cava (main vein in the abdomen).
         3. (iii) Filter migration or fracture (filter could break and/or move from where it was placed).
         4. (iv) Caval thrombosis (clotting of the main vein in the abdomen and episodes of swelling of legs).
         5. (v) Risk of recurrent pulmonary embolus (continued risk of blood clots going to blood vessels in the lungs despite filter).
         6. (vi) Inability to remove filter (for "optional"/retrievable filters).

      9. (I) Pulmonary angiography.

         1. (i) All associated risks as listed under paragraph (2)(B) of this subsection.
         2. (ii) Cardiac arrhythmia (irregular heart rhythm) or cardiac arrest (heart stops beating).
         3. (iii) Cardiac injury/perforation (heart injury).
         4. (iv) Death.

      10. (J) Percutaneous treatment of pseudoaneurysm (percutaneous thrombin injection versus compression).

          1. (i) Thrombosis (clotting) of supplying vessel or branches in its territory.
          2. (ii) Allergic reaction to thrombin (agent used for direct injection).

      11. (K) Vascular access - nontunneled catheters, tunneled catheters, implanted access.

          1. (i) Pneumothorax (collapsed lung).
          2. (ii) Injury to blood vessel.
          3. (iii) Hemothorax/hemomediastinum (bleeding into the chest around the lungs or around the heart).
          4. (iv) Air embolism (passage of air into blood vessel and possibly to the heart and/or blood vessels entering the lungs).
          5. (v) Vessel thrombosis (clotting of blood vessel).

      12. (L) Varicose vein treatment (percutaneous via laser, RFA, chemical or other method) without angiography.

          1. (i) Burns.
          2. (ii) Deep vein thrombosis (blood clots in deep veins).
          3. (iii) Hyperpigmentation (darkening of skin).
          4. (iv) Skin wound (ulcer).
          5. (v) Telangiectatic matting (appearance of tiny blood vessels in treated area).
          6. (vi) Paresthesia and dysesthesia (numbness or tingling in the area or limb treated).
          7. (vii) Injury to blood vessel requiring additional procedure to treat.

3. (c) Digestive system treatments and procedures.

   1. (1) Cholecystectomy with or without common bile duct exploration.

      1. (A) Pancreatitis.
      2. (B) Injury to the tube between the liver and the bowel.
      3. (C) Retained stones in the tube between the liver and the bowel.
      4. (D) Narrowing or obstruction of the tube between the liver and the bowel.
      5. (E) Injury to the bowel and/or intestinal obstruction.

   2. (2) Bariatric surgery.

      1. (A) Laparoscopic.

         1. (i) Conversion to open procedure.
         2. (ii) Injury to organs.
         3. (iii) Failure of device requiring additional surgical procedure.
         4. (iv) Obstructive symptoms requiring additional surgical procedure.
         5. (v) Development of gallstones (Roux-En-Y).
         6. (vi) Development of metabolic and vitamin disorders (Roux-En-Y).
         7. (vii) Suture line leak with abscess or fistula formation.

      2. (B) Open.

         1. (i) Failure of wound to heal or wound dehiscence (separation of wound).
         2. (ii) Injury to organs.
         3. (iii) Failure of device requiring additional surgical procedure.
         4. (iv) Obstructive symptoms requiring additional surgical procedure.
         5. (v) Development of gallstones (Roux-En-Y).
         6. (vi) Development of metabolic and vitamin disorders (Roux-En-Y).

   3. (3) Pancreatectomy (subtotal or total).

      1. (A) Pancreatitis (subtotal).
      2. (B) Diabetes (total).
      3. (C) Lifelong requirement of enzyme and digestive medication.
      4. (D) Anastamotic leaks.

   4. (4) Total colectomy.

      1. (A) Permanent ileostomy.
      2. (B) Injury to organs.
      3. (C) Infection.

   5. (5) Subtotal colectomy.

      1. (A) Anastomotic leaks.
      2. (B) Temporary colostomy.
      3. (C) Infection.
      4. (D) Second surgery.
      5. (E) Injury to organs.

   6. (6) Hepatobiliary drainage/intervention including percutaneous transhepatic cholangiography, percutaneous biliary drainage, percutaneous cholecystostomy, biliary stent placement (temporary or permanent), biliary stone removal/therapy.

      1. (A) Leakage of bile at the skin site or into the abdomen with possible peritonitis (inflammation of the abdominal lining and pain or if severe can be life threatening).
      2. (B) Pancreatitis (inflammation of the pancreas).
      3. (C) Hemobilia (bleeding into the bile ducts).
      4. (D) Cholangitis, cholecystitis, sepsis (inflammation/infection of the bile ducts, gallbladder or blood).
      5. (E) Pneumothorax (collapsed lung) or other pleural complications (complication involving chest cavity).

   7. (7) Gastrointestinal tract stenting.

      1. (A) Stent migration (stent moves from location in which it was placed).
      2. (B) Esophageal/bowel perforation (creation of a hole or tear in the tube from the throat to the stomach or in the intestines).
      3. (C) Tumor ingrowth or other obstruction of stent.

      4. (D) For stent placement in the esophagus (tube from the throat to the stomach).

         1. (i) Tracheal compression (narrowing of windpipe) with resulting or worsening of shortness of breath.
         2. (ii) Reflux (stomach contents passing up into esophagus or higher).
         3. (iii) Aspiration pneumonia (pneumonia from fluid getting in lungs) (if stent in lower part of the esophagus).
         4. (iv) Foreign body sensation (feeling like there is something in throat) (for stent placement in the upper esophagus).

4. (d) Ear treatments and procedures.

   1. (1) Stapedectomy.

      1. (A) Diminished or bad taste.
      2. (B) Total or partial loss of hearing in the operated ear.
      3. (C) Brief or long-standing dizziness.
      4. (D) Eardrum hole requiring more surgery.
      5. (E) Ringing in the ear.

   2. (2) Reconstruction of auricle of ear for congenital deformity or trauma.

      1. (A) Less satisfactory appearance compared to possible alternative artificial ear.
      2. (B) Exposure of implanted material.

   3. (3) Tympanoplasty with mastoidectomy.

      1. (A) Facial nerve paralysis.
      2. (B) Altered or loss of taste.
      3. (C) Recurrence of original disease process.
      4. (D) Total loss of hearing in operated ear.
      5. (E) Dizziness.
      6. (F) Ringing in the ear.

5. (e) Endocrine system treatments and procedures.

   1. (1) Thyroidectomy.

      1. (A) Acute airway obstruction requiring temporary tracheostomy.
      2. (B) Injury to nerves resulting in hoarseness or impairment of speech.
      3. (C) Injury to parathyroid glands resulting in low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness and muscle irritability.
      4. (D) Lifelong requirement of thyroid medication.

   2. (2) Parathyroidectomy.

      1. (A) Acute airway obstruction requiring temporary tracheostomy.
      2. (B) Injury to nerves resulting in hoarseness or impairment of speech.
      3. (C) Low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness, and muscle irritability.

   3. (3) Adrenalectomy.

      1. (A) Loss of endocrine functions.
      2. (B) Lifelong requirement for hormone replacement therapy and steroid medication.
      3. (C) Damage to kidneys.
   4. (4) Other procedures.
   5. (5) See also Pancreatectomy under subsection (c)(3) of this section (relating to digestive system treatments and procedures).

6. (f) Eye treatments and procedures.

   1. (1) Eye muscle surgery.

      1. (A) Additional treatment and/or surgery.
      2. (B) Double vision.
      3. (C) Partial or total blindness.

   2. (2) Surgery for cataract with or without implantation of intraocular lens.

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Need for glasses or contact lenses.
      3. (C) Complications requiring the removal of implanted lens.
      4. (D) Partial or total blindness.

   3. (3) Retinal or vitreous surgery.

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Recurrence or spread of disease.
      3. (C) Partial or total blindness.

   4. (4) Reconstructive and/or plastic surgical procedures of the eye and eye region, such as blepharoplasty, tumor, fracture, lacrimal surgery, foreign body, abscess, or trauma.

      1. (A) Worsening or unsatisfactory appearance.

      2. (B) Creation of additional problems.

         1. (i) Poor healing or skin loss.
         2. (ii) Nerve damage with loss of use and/or feeling.
         3. (iii) Painful or unattractive scarring.
         4. (iv) Impairment of regional organs (inability or decreased ability of regional organs to work), such as eye or lip function.
      3. (C) Recurrence of the original condition.

   5. (5) Photocoagulation and/or cryotherapy.

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Pain.
      3. (C) Partial or total blindness.

   6. (6) Corneal surgery, such as corneal transplant, refractive surgery and pterygium.

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Pain.
      3. (C) Need for glasses or contact lenses.
      4. (D) Partial or total blindness.

   7. (7) Glaucoma surgery by any method.

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Worsening of the glaucoma.
      3. (C) Pain.
      4. (D) Partial or total blindness.

   8. (8) Removal of the eye or its contents (enucleation or evisceration).

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Worsening or unsatisfactory appearance.
      3. (C) Recurrence or spread of disease.

   9. (9) Surgery for penetrating ocular injury, including intraocular foreign body.

      1. (A) Complications requiring additional treatment and/or surgery.
      2. (B) Possible removal of eye.
      3. (C) Pain.
      4. (D) Partial or total blindness.

7. (g) Female genital system treatments and procedures.

   1. (1) Abdominal hysterectomy (total).

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder.
      5. (E) Injury to the bowel and/or intestinal obstruction.

   2. (2) Vaginal hysterectomy.

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder.
      5. (E) Injury to the bowel and/or intestinal obstruction.
      6. (F) Completion of operation by abdominal incision.

   3. (3) All fallopian tube and ovarian surgery with or without hysterectomy, including removal and lysis of adhesions.

      1. (A) Injury to the bowel and/or bladder.
      2. (B) Sterility.
      3. (C) Failure to obtain fertility (if applicable).
      4. (D) Failure to obtain sterility (if applicable).
      5. (E) Loss of ovarian functions or hormone production from ovary(ies).
   4. (4) Reserved.

   5. (5) Removing fibroids (uterine myomectomy).

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder.
      5. (E) Injury to the bowel and/or intestinal obstruction.

   6. (6) Uterine suspension.

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder.
      5. (E) Injury to the bowel and/or intestinal obstruction.

   7. (7) Removal of the nerves to the uterus (presacral neurectomy).

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder.
      5. (E) Injury to the bowel and/or intestinal obstruction.
      6. (F) Hemorrhage, complications of hemorrhage, with additional operation.

   8. (8) Removal of the cervix.

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder
      5. (E) Injury to the bowel and/or intestinal obstruction.
      6. (F) Completion of operation by abdominal incision.

   9. (9) Repair of vaginal hernia (anterior and/or posterior colporrhaphy and/or enterocele repair).

      1. (A) Uncontrollable leakage of urine.
      2. (B) Injury to bladder.
      3. (C) Sterility.
      4. (D) Injury to the tube (ureter) between the kidney and the bladder.
      5. (E) Injury to the bowel and/or intestinal obstruction.

   10. (10) Abdominal suspension of the bladder (retropubic urethropexy).

       1. (A) Uncontrollable leakage of urine.
       2. (B) Injury to bladder.
       3. (C) Injury to the tube (ureter) between the kidney and the bladder.
       4. (D) Injury to the bowel and/or intestinal obstruction.

   11. (11) Conization of cervix.

       1. (A) Hemorrhage with possible hysterectomy to control.
       2. (B) Sterility.
       3. (C) Injury to bladder.
       4. (D) Injury to rectum.
       5. (E) Failure of procedure to remove all of cervical abnormality.

   12. (12) Dilation and curettage of uterus (diagnostic/therapeutic).

       1. (A) Hemorrhage with possible hysterectomy.
       2. (B) Perforation of the uterus.
       3. (C) Sterility.
       4. (D) Injury to bowel and/or bladder.
       5. (E) Abdominal incision and operation to correct injury.

   13. (13) Surgical abortion/dilation and curettage/dilation and evacuation.

       1. (A) Hemorrhage with possible hysterectomy to control.
       2. (B) Perforation of the uterus.
       3. (C) Sterility.
       4. (D) Injury to the bowel and/or bladder.
       5. (E) Abdominal incision and operation to correct injury.
       6. (F) Failure to remove all products of conception.

   14. (14) Medical abortion/non-surgical.

       1. (A) Hemorrhage with possible need for surgical intervention.
       2. (B) Failure to remove all products of conception.
       3. (C) Sterility.

   15. (15) Selective salpingography and Fallopian tube recanalization.

       1. (A) Perforation (hole) created in the uterus or Fallopian tube.
       2. (B) Ectopic pregnancy (pregnancy outside of the uterus).
       3. (C) Pelvic infection.

   16. (16) Fallopian tube occlusion (for sterilization).

       1. (A) Risks listed in selective salpingography and Fallopian tube recanalization.
       2. (B) Failure to provide sterilization.
       3. (C) Coil expulsion (coil falls out of Fallopian tube).

8. (h) Hematic and lymphatic system.

   1. (1) Transfusion of blood and blood components.

      1. (A) Fever.
      2. (B) Transfusion reaction which may include kidney failure or anemia.
      3. (C) Heart failure.
      4. (D) Hepatitis.
      5. (E) AIDS (acquired immune deficiency syndrome).
      6. (F) Other infections.

   2. (2) Splenectomy.

      1. (A) Susceptibility to infections and increased severity of infections.
      2. (B) Increased immunization requirements.

9. (i) Integumentary system treatments and procedures.

   1. (1) Radical or modified radical mastectomy. (Simple mastectomy excluded).

      1. (A) Limitation of movement of shoulder and arm.
      2. (B) Swelling of the arm.
      3. (C) Loss of the skin of the chest requiring skin graft.
      4. (D) Recurrence of malignancy, if present.
      5. (E) Decreased sensation or numbness of the inner aspect of the arm and chest wall.

   2. (2) Reconstruction and/or plastic surgical operations of the face and neck.

      1. (A) Worsening or unsatisfactory appearance.

      2. (B) Creation of several additional problems.

         1. (i) Poor healing or skin loss.
         2. (ii) Nerve damage.
         3. (iii) Painful or unattractive scarring.
         4. (iv) Impairment of regional organs, such as eye or lip function.
      3. (C) Recurrence of the original condition.

10. (j) Male genital system.

    1. (1) Orchidopexy (reposition of testis(es)).

       1. (A) Removal of testicle.
       2. (B) Atrophy (shriveling) of the testicle with loss of function.

    2. (2) Orchiectomy (removal of the testis(es)).

       1. (A) Decreased sexual desire.
       2. (B) Difficulties with penile erection.
       3. (C) Permanent sterility (inability to father children) if both testes are removed.

    3. (3) Vasectomy.

       1. (A) Loss of testicle.
       2. (B) Failure to produce permanent sterility (inability to father children).

11. (k) Maternity and related cases.

    1. (1) Delivery (vaginal).

       1. (A) Injury to bladder and/or rectum, including a fistula (hole) between bladder and vagina and/or rectum and vagina.
       2. (B) Hemorrhage (severe bleeding) possibly requiring blood administration and/or hysterectomy (removal of uterus) and/or artery ligation (tying off) to control.
       3. (C) Sterility (inability to get pregnant).
       4. (D) Brain damage, injury or even death occurring to the fetus before or during labor and/or vaginal delivery whether or not the cause is known.

    2. (2) Delivery (cesarean section).

       1. (A) Injury to bowel and/or bladder.
       2. (B) Sterility (inability to get pregnant).
       3. (C) Injury to ureter (tube between kidney and bladder).
       4. (D) Brain damage, injury or even death occurring to the fetus before or during labor and/or cesarean delivery whether or not the cause is known.
       5. (E) Uterine disease or injury requiring hysterectomy (removal of uterus).

    3. (3) Cerclage.

       1. (A) Premature labor.
       2. (B) Injury to bowel and/or bladder.

12. (l) Musculoskeletal system treatments and procedures.

    1. (1) Arthroplasty of any joints with mechanical device.

       1. (A) Impaired function such as shortening or deformity.
       2. (B) Blood vessel or nerve injury.
       3. (C) Pain or discomfort.
       4. (D) Blood clot in blood vessels which can block flow of blood to lungs or limbs and/or cause swelling in limbs.
       5. (E) Failure of bone to heal.
       6. (F) Bone infection.
       7. (G) Removal or replacement of any implanted device or material.
       8. (H) Various functional or cosmetic growth deformities requiring additional surgery.

    2. (2) Arthroscopy of any joint.

       1. (A) Blood vessel or nerve injury.
       2. (B) Continued pain.
       3. (C) Stiffness of joint.
       4. (D) Blood clot in blood vessels which can block flow of blood to lungs or limbs and/or cause swelling in limbs.
       5. (E) Joint infection.
       6. (F) Various functional or cosmetic growth deformities requiring additional surgery.

    3. (3) Open reduction with internal fixation.

       1. (A) Impaired function such as shortening or deformity.
       2. (B) Blood vessel or nerve injury.
       3. (C) Pain or discomfort.
       4. (D) Blood clot in blood vessels which can block flow of blood to lungs or limbs and/or cause swelling in limbs.
       5. (E) Failure of bone to heal.
       6. (F) Bone infection.
       7. (G) Removal or replacement of any implanted device or material.
       8. (H) Problems with appearance, use, or growth requiring additional surgery.

    4. (4) Osteotomy.

       1. (A) Impaired function such as shortening or deformity.
       2. (B) Blood vessel or nerve injury.
       3. (C) Pain or discomfort.
       4. (D) Blood clot in blood vessels which can block flow of blood to lungs or limbs and/or cause swelling in limbs.
       5. (E) Failure of bone to heal.
       6. (F) Bone infection.
       7. (G) Removal or replacement of any implanted device or material.

    5. (5) Ligamentous reconstruction of joints.

       1. (A) Failure of reconstruction to work.
       2. (B) Continued instability of the joint.
       3. (C) Degenerative arthritis.
       4. (D) Continued pain.
       5. (E) Stiffness of joint.
       6. (F) Blood vessel or nerve injury.
       7. (G) Impaired function and/or scarring.
       8. (H) Blood clot in blood vessels which can block flow of blood to lungs or limbs and/or cause swelling in limbs.
    6. (6) All other orthopedic procedures on children age 12 or under. Problems with appearance, use, or growth requiring additional surgery.

    7. (7) Vertebroplasty/kyphoplasty.

       1. (A) Nerve/spinal cord injury.
       2. (B) Need for emergency surgery.
       3. (C) Embolization of cement (cement used passes into blood vessels and possibly all the way to the blood vessels in the lungs).
       4. (D) Fracture of adjacent vertebrae (bones in spine).
       5. (E) Leak of cerebrospinal fluid (fluid around the brain and spinal cord).
       6. (F) Pneumothorax (collapsed lung).
       7. (G) Worsening of pain.
       8. (H) Rib or vertebral (spine) fracture.

13. (m) Nervous system treatments and procedures.

    1. (1) Craniotomy, craniectomy or cranioplasty.

       1. (A) Additional loss of brain function including memory.
       2. (B) Recurrence, continuation or worsening of the condition that required this operation.
       3. (C) Stroke.
       4. (D) Blindness, deafness, inability to smell, double vision, coordination loss, seizures, pain, numbness and paralysis.
       5. (E) Cerebral spinal fluid leak with potential for meningitis and severe headaches.
       6. (F) Meningitis.
       7. (G) Brain abscess.
       8. (H) Persistent vegetative state.
       9. (I) Heart attack.

    2. (2) Cranial nerve operations.

       1. (A) Numbness, impaired muscle function or paralysis.
       2. (B) Recurrence, continuation or worsening of the condition that required this operation.
       3. (C) Seizures.
       4. (D) New or different pain.

    3. (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).

       1. (A) Pain, numbness or clumsiness.
       2. (B) Impaired muscle function or paralysis.
       3. (C) Incontinence, impotence or impaired bowel function.
       4. (D) Unstable spine.
       5. (E) Recurrence, continuation or worsening of the condition that required the operation.
       6. (F) Injury to major blood vessels.
       7. (G) Hemorrhage.

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

       1. (A) Numbness.
       2. (B) Impaired muscle function.
       3. (C) Recurrence, continuation or worsening of the condition that required the operation.
       4. (D) Continued, increased or different pain.

    5. (5) Transphenoidal hypophysectomy or other pituitary gland operation.

       1. (A) Spinal fluid leak.
       2. (B) Necessity for hormone replacement.
       3. (C) Recurrence or continuation of the condition that required this operation.
       4. (D) Nasal septal deformity or perforation.
       5. (E) Facial numbness and disfigurement.
       6. (F) Blindness.

    6. (6) Cerebral spinal fluid shunting procedure or revision.

       1. (A) Shunt obstruction, migration or infection.
       2. (B) Seizure disorder.
       3. (C) Recurrence or continuation of brain dysfunction.
       4. (D) Injury to internal organs.
       5. (E) Possible brain injury or hemorrhage.

14. (n) Radiology.

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

       1. (A) All associated risks as listed under subsection (b)(2)(B) of this section.
       2. (B) Injury to the spleen requiring blood transfusion and/or removal of the spleen.

    2. (2) Chemoembolization.

       1. (A) All associated risks as listed under subsection (b)(2)(B) of this section.
       2. (B) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).
       3. (C) Injury to or failure of liver (or other organ in which tumor is located).
       4. (D) Risks of the chemotherapeutic agent(s) utilized.
       5. (E) Cholecystitis (inflammation of the gallbladder) (for liver or other upper GI embolizations).
       6. (F) Abscess (infected fluid collection) in the liver or other embolized organ requiring further intervention.
       7. (G) Biloma (collection of bile in or near the liver requiring drainage) (for liver embolizations).

    3. (3) Radioembolization.

       1. (A) All associated risks as listed under subsection (b)(2)(B) of this section.
       2. (B) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).
       3. (C) Injury to or failure of liver (or other organ in which tumor is located).
       4. (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. (4) Thermal and other ablative techniques for treatment of tumors (for curative intent or palliation) including radiofrequency ablation, cryoablation, and high intensity focused ultrasound (HIFU), irreversible electroporation.

       1. (A) Injury to tumor-containing organ or adjacent organs/structures.
       2. (B) Injury to nearby nerves potentially resulting in temporary or chronic (continuing) pain and/or loss of use and/or feeling.
       3. (C) Failure to completely treat tumor.

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

       1. (A) All associated risks as listed under subsection (b)(2)(B) - (D) of this section.
       2. (B) Hepatic encephalopathy (confusion/decreased ability to think).
       3. (C) Liver failure or injury.
       4. (D) Gallbladder injury.
       5. (E) Hemorrhage (severe bleeding).
       6. (F) Recurrent ascites (fluid building up in abdomen) and/or bleeding.
       7. (G) Kidney failure.
       8. (H) Heart failure.
       9. (I) Death.

    6. (6) Myelography.

       1. (A) Chronic (continuing) pain.
       2. (B) Nerve injury with loss of use and/or feeling.
       3. (C) Transient (temporary) headache, nausea, and/or vomiting.
       4. (D) Numbness.
       5. (E) Seizure.

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

       1. (A) Sepsis (infection in the blood stream), possibly resulting in shock (severe decrease in blood pressure).
       2. (B) Injury to nearby organs.
       3. (C) Hemorrhage (severe bleeding).
       4. (D) Infection of collection which was not previously infected, or additional infection of abscess.

    8. (8) Procedures utilizing prolonged fluoroscopy.

       1. (A) Skin injury (such as epilation (hair loss), burns, or ulcers).
       2. (B) Cataracts (for procedures in the region of the head).

15. (o) Respiratory system treatments and procedures.

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

       1. (A) Loss or change of voice.
       2. (B) Swallowing or breathing difficulties.
       3. (C) Perforation (hole) or fistula (connection) in esophagus (tube from throat to stomach).

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

       1. (A) Deformity of skin, bone or cartilage.
       2. (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. (3) Submucous resection of nasal septum or nasal septoplasty.

       1. (A) Persistence, recurrence or worsening of the obstruction.
       2. (B) Perforation of nasal septum (hole in wall between the right and left halves of the nose) with dryness and crusting.
       3. (C) External deformity of the nose.

    4. (4) Lung biopsy.

       1. (A) Pneumothorax (collapsed lung).
       2. (B) Hemothorax (blood in the chest around the lung).

    5. (5) Segmental resection of lung.

       1. (A) Hemothorax (blood in the chest around the lung).
       2. (B) Abscess (infected fluid collection) in chest.
       3. (C) Insertion of tube into space between lung and chest wall or repeat surgery.
       4. (D) Need for additional surgery.

    6. (6) Thoracotomy.

       1. (A) Hemothorax (blood in the chest around the lung).
       2. (B) Abscess (infected fluid collection) in chest.
       3. (C) Pneumothorax (collapsed lung).
       4. (D) Need for additional surgery.

    7. (7) Thoracotomy with drainage.

       1. (A) Hemothorax (blood in the chest around the lung).
       2. (B) Abscess (infected fluid collection) in chest.
       3. (C) Pneumothorax (collapsed lung).
       4. (D) Need for additional surgery.

    8. (8) Open tracheostomy.

       1. (A) Loss of voice.
       2. (B) Breathing difficulties.
       3. (C) Pneumothorax (collapsed lung).
       4. (D) Hemothorax (blood in the chest around the lung).
       5. (E) Scarring in trachea (windpipe).
       6. (F) Fistula (connection) between trachea into esophagus (tube from throat to stomach) or great vessels.

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

       1. (A) Stent migration (stent moves from position in which it was placed).
       2. (B) Pneumomediastinum (air enters the space around the airways including the space around the heart).
       3. (C) Mucosal injury (injury to lining of airways).

16. (p) Urinary system.

    1. (1) Partial nephrectomy (removal of part of the kidney).

       1. (A) Incomplete removal of stone(s) or tumor, if present.
       2. (B) Blockage of urine.
       3. (C) Leakage of urine at surgical site.
       4. (D) Injury to or loss of the kidney.
       5. (E) Damage to organs next to kidney.

    2. (2) Radical nephrectomy (removal of kidney and adrenal gland for cancer).

       1. (A) Loss of the adrenal gland (gland on top of kidney that makes certain hormones/chemicals the body needs).
       2. (B) Incomplete removal of tumor.
       3. (C) Damage to organs next to kidney.

    3. (3) Nephrectomy (removal of kidney).

       1. (A) Incomplete removal of tumor if present.
       2. (B) Damage to organs next to kidney.
       3. (C) Injury to or loss of the kidney.

    4. (4) Nephrolithotomy and pyelolithotomy (removal of kidney stone(s)).

       1. (A) Incomplete removal of stone(s).
       2. (B) Blockage of urine.
       3. (C) Leakage of urine at surgical site.
       4. (D) Injury or loss of the kidney.
       5. (E) Damage to organs next to kidney.

    5. (5) Pyeloureteroplasty (pyeloplasty or reconstruction of the kidney drainage system).

       1. (A) Blockage of urine.
       2. (B) Leakage of urine at surgical site.
       3. (C) Injury to or loss of the kidney.
       4. (D) Damage to organs next to kidney.

    6. (6) Exploration of kidney or perinephric mass.

       1. (A) Incomplete removal of stone(s) or tumor, if present.
       2. (B) Leakage of urine at surgical site.
       3. (C) Injury to or loss of the kidney.
       4. (D) Damage to organs next to kidney.

    7. (7) Ureteroplasty (reconstruction of ureter (tube between kidney and bladder)).

       1. (A) Leakage of urine at surgical site.
       2. (B) Incomplete removal of the stone or tumor (when applicable).
       3. (C) Blockage of urine.
       4. (D) Damage to organs next to ureter.
       5. (E) Damage to or loss of the ureter.

    8. (8) Ureterolithotomy (surgical removal of stone(s) from ureter (tube between kidney and bladder)).

       1. (A) Leakage of urine at surgical site.
       2. (B) Incomplete removal of stone.
       3. (C) Blockage of urine.
       4. (D) Damage to organs next to ureter.
       5. (E) Damage to or loss of ureter.

    9. (9) Ureterectomy (partial/complete removal of ureter (tube between kidney and bladder)).

       1. (A) Leakage of urine at surgical site.
       2. (B) Incomplete removal of stone.
       3. (C) Blockage of urine.
       4. (D) Damage to organs next to ureter.

    10. (10) Ureterolysis (partial/complete removal of ureter (tube between kidney and bladder from adjacent tissue)).

        1. (A) Leakage of urine at surgical site.
        2. (B) Blockage of urine.
        3. (C) Damage to organs next to ureter.
        4. (D) Damage to or loss of ureter.

    11. (11) Ureteral reimplantation (reinserting ureter (tube between kidney and bladder) into the bladder).

        1. (A) Leakage of urine at surgical site.
        2. (B) Blockage of urine.
        3. (C) Damage to or loss of ureter.
        4. (D) Backward flow of urine from bladder into ureter.
        5. (E) Damage to organs next to ureter.

    12. (12) Prostatectomy (partial or total removal of prostate).

        1. (A) Leakage of urine at surgical site.
        2. (B) Blockage of urine.
        3. (C) Incontinence (difficulty with control of urine flow).
        4. (D) Semen passing backward into bladder.
        5. (E) Difficulty with penile erection (possible with partial and probable with total prostatectomy).

    13. (13) Total cystectomy (removal of bladder).

        1. (A) Probable loss of penile erection and ejaculation in the male.
        2. (B) Damage to organs next to bladder.
        3. (C) This procedure will require an alternate method of urinary drainage.

    14. (14) Radical cystectomy.

        1. (A) Probable loss of penile erection and ejaculation in the male.
        2. (B) Damage to organs next to bladder.
        3. (C) This procedure will require an alternate method of urinary drainage.
        4. (D) Chronic (continuing) swelling of thighs, legs and feet.
        5. (E) Recurrence or spread of cancer if present.

    15. (15) Partial cystectomy (partial removal of bladder).

        1. (A) Leakage of urine at surgical site.
        2. (B) Incontinence (difficulty with control of urine flow).
        3. (C) Backward flow of urine from bladder into ureter (tube between kidney and bladder).
        4. (D) Blockage of urine.
        5. (E) Damage to organs next to bladder.

    16. (16) Urinary diversion (ileal conduit, colon conduit).

        1. (A) Blood chemistry abnormalities requiring medication.
        2. (B) Development of stones, strictures or infection in the kidneys, ureter or bowel (intestine).
        3. (C) Leakage of urine at surgical site.
        4. (D) This procedure will require an alternate method of urinary drainage.

    17. (17) Ureterosigmoidostomy (placement of kidney drainage tubes into the large bowel (intestine)).

        1. (A) Blood chemistry abnormalities requiring medication.
        2. (B) Development of stones, strictures or infection in the kidneys, ureter or bowel (intestine).
        3. (C) Leakage of urine at surgical site.
        4. (D) Difficulty in holding urine in the rectum.

    18. (18) Urethroplasty (construction/reconstruction of drainage tube from bladder).

        1. (A) Leakage of urine at surgical site.
        2. (B) Stricture formation (narrowing of urethra (tube from bladder to outside)).
        3. (C) Need for additional surgery.

    19. (19) Percutaneous nephrostomy/stenting/stone removal.

        1. (A) Pneumothorax or other pleural complications (collapsed lung or filling of the chest cavity on the same side with fluid).
        2. (B) Septic shock/bacteremia (infection of the blood stream with possible shock/severe lowering of blood pressure) when pyonephrosis (infected urine in the kidney) present.
        3. (C) Bowel (intestinal) injury.
        4. (D) Blood vessel injury with or without significant bleeding.

    20. (20) Dialysis (technique to replace functions of kidney and clean blood of toxins).

        1. (A) Hemodialysis.

           1. (i) Hypotension (low blood pressure).
           2. (ii) Hypertension (high blood pressure).
           3. (iii) Air embolism (air bubble in blood vessel) resulting in possible death or paralysis.
           4. (iv) Cardiac arrhythmias (irregular heart rhythms).
           5. (v) Infections of blood stream, access site, or blood borne (for example: Hepatitis B, C, or HIV).
           6. (vi) Hemorrhage (severe bleeding as a result of clotting problems or due to disconnection of the bloodline).
           7. (vii) Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis.
           8. (viii) Allergic reactions.
           9. (ix) Chemical imbalances and metabolic disorders (unintended change in blood minerals).
           10. (x) Pyrogenic reactions (fever).
           11. (xi) Hemolysis (rupture of red blood cells).
           12. (xii) Graft/fistula damage including bleeding, aneurysm, formation (ballooning of vessel), clotting (closure) of graft/fistula.

        2. (B) Peritoneal dialysis.

           1. (i) Infections, including peritonitis (inflammation or irritation of the tissue lining the inside wall of abdomen and covering organs), catheter infection and catheter exit site infection.
           2. (ii) Development of hernias of umbilicus (weakening of abdominal wall or muscle).
           3. (iii) Hypertension (high blood pressure).
           4. (iv) Hypotension (low blood pressure).
           5. (v) Hydrothorax (fluid in chest cavity).
           6. (vi) Arrhythmia (irregular heart rhythm).
           7. (vii) Perforation of the bowel.
           8. (viii) Sclerosis or scarring of the peritoneum.
           9. (ix) Weight gain leading to obesity.
           10. (x) Abdominal discomfort/distension.
           11. (xi) Heartburn or reflux.
           12. (xii) Increase in need for anti-diabetic medication.
           13. (xiii) Muscle weakness.
           14. (xiv) Dehydration (extreme loss of body fluid).
           15. (xv) Chemical imbalances and metabolic disorders (unintended change in blood minerals).
           16. (xvi) Allergic reactions.
           17. (xvii) Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis.

17. (q) Psychiatric procedures.

    1. (1) Electroconvulsive therapy with modification by intravenous muscle relaxants and sedatives.

       1. (A) Memory changes of events prior to, during, and immediately following the treatment.
       2. (B) Fractures or dislocations of bones.
       3. (C) Significant temporary confusion requiring special care.
    2. (2) Other Procedures. No other procedures are assigned at this time.

18. (r) Radiation therapy. A child is defined for the purpose of this subsection as an individual who is not physiologically mature as determined by the physician using the appropriate medical parameters.

    1. (1) Head and neck.

       1. (A) Early reactions.

          1. (i) Reduced and sticky saliva, loss of taste and appetite, altered sense of smell, nausea.
          2. (ii) Sore throat, difficulty swallowing, weight loss, fatigue.
          3. (iii) Skin changes: redness, irritation, scaliness, blistering or ulceration, color change, thickening, hair loss.
          4. (iv) Hoarseness, cough, loss of voice, and swelling of airway.
          5. (v) Blockage and crusting of nasal passages.
          6. (vi) Inflammation of ear canal, feeling of "stopped up" ear, hearing loss, dizziness.
          7. (vii) Dry and irritable eye(s).
          8. (viii) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.
          9. (ix) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Dry mouth and altered sense, or loss, of taste.
          2. (ii) Tooth decay and gum changes.
          3. (iii) Bone damage, especially in jaws.
          4. (iv) Stiffness and limitation of jaw movement.
          5. (v) Changes in skin texture and/or coloration, permanent hair loss, and scarring of skin.
          6. (vi) Swelling of tissues, particularly under the chin.
          7. (vii) Throat damage causing hoarseness, pain or difficulty breathing or swallowing.
          8. (viii) Eye damage causing dry eye(s), cataract, loss of vision, or loss of eye(s).
          9. (ix) Ear damage causing dryness of ear canal, fluid collection in middle ear, hearing loss.
          10. (x) Brain, spinal cord or nerve damage causing alteration of thinking ability or memory, and/or loss of strength, feeling or coordination in any part of the body.
          11. (xi) Pituitary or thyroid gland damage requiring long-term hormone replacement therapy.

          12. (xii) In children, there may be additional late reactions.

              1. (I) Disturbance of bone and tissue growth.
              2. (II) Bone damage to face causing abnormal development.
              3. (III) Brain damage causing a loss of intellectual ability, learning capacity, and reduced intelligence quotient (IQ).
              4. (IV) Second cancers developing in the irradiated area.

    2. (2) Central nervous system.

       1. (A) Early reactions.

          1. (i) Skin and scalp reaction with redness, irritation, scaliness, blistering, ulceration, change in color, thickening, hair loss.
          2. (ii) Nausea, vomiting, headaches.
          3. (iii) Fatigue, drowsiness.
          4. (iv) Altered sense of taste or smell.
          5. (v) Inflammation of ear canal, feeling of "stopped-up" ear, hearing loss, dizziness.
          6. (vi) Depression of blood count leading to increased risk of infection and/or bleeding.
          7. (vii) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.
          8. (viii) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Permanent hair loss of variable degrees, altered regrowth, texture and color of hair.
          2. (ii) Persistent drowsiness and tiredness.
          3. (iii) Brain damage causing a loss of some degree of thinking ability or memory, or personality changes.
          4. (iv) Scarring of skin.
          5. (v) Spinal cord or nerve damage causing loss of strength, feeling or coordination in any part of the body.
          6. (vi) Damage to eye(s), or optic nerve(s) causing loss of vision.
          7. (vii) Ear damage causing dryness of ear canal, fluid collection in middle ear, hearing loss.
          8. (viii) Pituitary gland damage requiring long-term hormone replacement therapy.

          9. (ix) In children, there may be additional late reactions.

             1. (I) Disturbances of bone and tissue growth.
             2. (II) Bone damage to spine, causing stunting of growth, curvature and/or reduction in height.
             3. (III) Bone damage to face, or pelvis causing stunting of bone growth and/or abnormal development.
             4. (IV) Brain damage causing a loss of intellectual ability, learning capacity, and reduced intelligence quotient (IQ).
             5. (V) Second cancers developing in the irradiated area.

    3. (3) Thorax.

       1. (A) Early reactions.

          1. (i) Skin changes: redness, irritation, scaliness, ulceration, change in color, thickening, hair loss.
          2. (ii) Inflammation of esophagus causing pain on swallowing, heartburn, or sense of obstruction.
          3. (iii) Loss of appetite, nausea, vomiting.
          4. (iv) Weight loss, weakness, vomiting.
          5. (v) Inflammation of the lung with pain, fever and cough.
          6. (vi) Inflammation of the heart sac with chest pain and palpitations.
          7. (vii) Bleeding or creation of a fistula resulting from tumor destruction.
          8. (viii) Depression of blood count leading to increased risk of infection and/or bleeding.
          9. (ix) Intermittent electric shock-like feelings in the lower spine or legs on bending the neck.
          10. (x) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.
          11. (xi) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Changes in skin texture and/or coloration, permanent hair loss and scarring of skin.
          2. (ii) Lung scarring or shrinkage causing shortness of breath.
          3. (iii) Narrowing of esophagus causing swallowing problems.
          4. (iv) Constriction of heart sac which may require surgical correction.
          5. (v) Damage to heart muscle or arteries leading to heart failure.
          6. (vi) Fracture of ribs.
          7. (vii) Nerve damage causing pain, loss of strength or feeling in arms.
          8. (viii) Spinal cord damage causing loss of strength or feeling in arms and legs, and/or loss of control of bladder and rectum.

          9. (ix) In children, there may be additional late reactions.

             1. (I) Disturbances of bone and tissue growth.
             2. (II) Bone damage to spine, causing stunting of growth, curvature and/or reduction in height.
             3. (III) Underdevelopment or absence of development of female breast.
             4. (IV) Second cancers developing in the irradiated area.

    4. (4) Breast.

       1. (A) Early reactions.

          1. (i) Skin changes: redness, irritation, scaliness, blistering, ulceration, coloration, thickening, and hair loss.
          2. (ii) Breast changes including swelling, tightness, or tenderness.
          3. (iii) Inflammation of the esophagus causing pain or swallowing, heartburn, or sense of obstruction.
          4. (iv) Lung inflammation with cough.
          5. (v) Inflammation of heart sac with chest pain and palpitations.

       2. (B) Late reactions.

          1. (i) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.
          2. (ii) Breast changes including thickening, firmness, tenderness, shrinkage.
          3. (iii) Swelling of arm.
          4. (iv) Stiffness and discomfort in shoulder joint.
          5. (v) Rib or lung damage causing pain, fracture, cough, shortness of breath.
          6. (vi) Nerve damage causing pain, loss of strength or feeling in arm.
          7. (vii) Damage to heart muscle or arteries or heart sac leading to heart failure.

    5. (5) Abdomen.

       1. (A) Early reactions.

          1. (i) Skin changes: redness, irritation, scaliness, ulceration, coloration, thickening, hair loss.
          2. (ii) Loss of appetite, nausea, vomiting.
          3. (iii) Weight loss, weakness, fatigue.
          4. (iv) Inflammation of stomach causing indigestion, heartburn, and ulcers.
          5. (v) Inflammation of bowel causing cramping and diarrhea.
          6. (vi) Depression of blood count leading to increased risk of infections and/or bleeding.
          7. (vii) In children, these reactions are likely to be intensified by chemotherapy before, during and after radiation therapy.
          8. (viii) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.
          2. (ii) Stomach damage causing persistent indigestion, pain, and bleeding.
          3. (iii) Bowel damage causing narrowing or adhesions of bowel with obstruction, ulceration, or bleeding which may require surgical correction, chronic diarrhea, or poor absorption of food elements.
          4. (iv) Kidney damage leading to kidney failure and/or high blood pressure.
          5. (v) Liver damage leading to liver failure.
          6. (vi) Spinal cord or nerve damage causing loss of strength or feeling in legs and/or loss of control of bladder and/or rectum.

          7. (vii) In children, there may be additional late reactions.

             1. (I) Disturbances of bone and tissue growth.
             2. (II) Bone damage to spine causing stunting of growth, curvature and/or reduction in height.
             3. (III) Bone damage to pelvis causing stunting of bone growth and/or abnormal development.
             4. (IV) Second cancers developing in the irradiated area.

    6. (6) Female pelvis.

       1. (A) Early reactions.

          1. (i) Inflammation of bowel causing cramping and diarrhea.
          2. (ii) Inflammation of rectum and anus causing pain, spasm, discharge, bleeding.
          3. (iii) Bladder inflammation causing burning, frequency, spasm, pain, bleeding.
          4. (iv) Skin changes: redness, irritation, scaliness, blistering or ulceration, coloration, thickening, hair loss.
          5. (v) Disturbance of menstrual cycle.
          6. (vi) Vaginal discharge, pain, irritation, bleeding.
          7. (vii) Depression of blood count leading to increased risk of infection and/or bleeding.
          8. (viii) In children, these reactions are likely to be intensified by chemotherapy before, during, or after radiation therapy.
          9. (ix) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Bowel damage causing narrowing or adhesions of the bowel with obstruction, ulceration, bleeding, chronic diarrhea, or poor absorption of food elements and may require surgical correction or colostomy.
          2. (ii) Bladder damage with loss of capacity, frequency of urination, blood in urine, recurrent urinary infections, pain, or spasm which may require urinary diversion and/or removal of bladder.
          3. (iii) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.
          4. (iv) Bone damage leading to fractures.
          5. (v) Ovarian damage causing infertility, sterility, or premature menopause.
          6. (vi) Vaginal damage leading to dryness, shrinkage, pain, bleeding, or sexual dysfunction.
          7. (vii) Swelling of the genitalia or legs.
          8. (viii) Nerve damage causing pain, loss of strength or feeling in legs, and/or loss of control of bladder or rectum.
          9. (ix) Fistula between the bladder and/or bowel and/or vagina.

          10. (x) In children, there may be additional late reactions.

              1. (I) Disturbances of bone and tissue growth.
              2. (II) Bone damage to pelvis and hips causing stunting of bone growth and/or abnormal development.
              3. (III) Second cancers developing in the irradiated area.

    7. (7) Male pelvis.

       1. (A) Early reactions.

          1. (i) Inflammation of bowel causing cramping and diarrhea.
          2. (ii) Inflammation of rectum and anus causing pain, spasm, discharge, bleeding.
          3. (iii) Bladder inflammation causing burning, frequency, spasm, pain, and/or bleeding.
          4. (iv) Skin changes: redness, irritation, scaliness, blistering or ulceration, coloration, thickening, hair loss.
          5. (v) Depression of blood count leading to increased risk of infection and/or bleeding.
          6. (vi) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.
          7. (vii) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Bowel damage causing narrowing or adhesions of the bowel with obstruction, ulceration, bleeding, chronic diarrhea, or poor absorption of food elements and may require surgical correction or colostomy.
          2. (ii) Bladder damage with loss of capacity, frequency of urination, blood in urine, recurrent urinary infections, pain, or spasm which may require urinary diversion and/or removal of bladder.
          3. (iii) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.
          4. (iv) Bone damage leading to fractures.
          5. (v) Testicular damage causing reduced sperm counts, infertility, sterility, or risk of birth defects.
          6. (vi) Impotence (loss of erection) or sexual dysfunction.
          7. (vii) Swelling of the genitalia or legs.
          8. (viii) Nerve damage causing pain, loss of strength or feeling in legs, and/or loss of control of bladder or rectum.
          9. (ix) Fistula between the bowel and other organs.

          10. (x) In children, there may be additional late reactions.

              1. (I) Disturbances of bone and tissue growth.
              2. (II) Bone damage to pelvis and hips causing stunting of bone growth and/or abnormal development.
              3. (III) Second cancers developing in the irradiated area.

    8. (8) Skin.

       1. (A) Early reactions.

          1. (i) Redness, irritation, or soreness.
          2. (ii) Scaliness, ulceration, crusting, oozing, discharge.
          3. (iii) Hair loss.
          4. (iv) These reactions are likely to be intensified by chemotherapy.

       2. (B) Late reactions.

          1. (i) Changes in skin texture causing scaly or shiny smooth skin, thickening with contracture, puckering, scarring of skin.
          2. (ii) Changes in skin color.
          3. (iii) Prominent dilated small blood vessels.
          4. (iv) Permanent hair loss.
          5. (v) Chronic or recurrent ulcerations.
          6. (vi) Damage to adjacent tissues including underlying bone or cartilage.
          7. (vii) In children, second cancers may develop in the irradiated area.

    9. (9) Extremities.

       1. (A) Early reactions.

          1. (i) Skin changes: redness, irritation, scaliness, ulceration, coloration, thickening, hair loss.
          2. (ii) Inflammation of soft tissues causing tenderness, swelling, and interference with movement.
          3. (iii) Inflammation of joints causing pain, swelling and limitation of joint motion.
          4. (iv) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.
          5. (v) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

       2. (B) Late reactions.

          1. (i) Changes in skin reaction and/or coloration, permanent hair loss and scarring of the skin.
          2. (ii) Scarring or shrinkage of soft tissues and muscle causing loss of flexibility and movement, swelling of the limb.
          3. (iii) Nerve damage causing loss of strength, feeling or coordination.
          4. (iv) Bone damage causing fracture.
          5. (v) Joint damage causing permanent stiffness, pains and arthritis.
          6. (vi) Swelling of limb below the area treated.

          7. (vii) In children, there may be additional late reactions.

             1. (I) Disturbances of bone and tissue growth.
             2. (II) Bone damage to limbs causing stunting of bone growth and/or abnormal development.
             3. (III) Second cancers developing in the irradiated area.

    10. (10) Total body irradiation.

        1. (A) Early reactions.

           1. (i) Loss of appetite, nausea, vomiting.
           2. (ii) Diarrhea.
           3. (iii) Reduced and sticky saliva, swelling of the salivary gland(s), loss of taste.
           4. (iv) Hair loss.
           5. (v) Sore mouth and throat, difficulty swallowing.
           6. (vi) Permanent destruction of bone marrow leading to infection, bleeding, and possible death.
           7. (vii) Inflammation of the lung with fever, dry cough and difficulty breathing with possible fatal lung failure.
           8. (viii) Damage to liver with possible fatal liver failure.
           9. (ix) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.
           10. (x) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.

        2. (B) Late reactions.

           1. (i) Lung scarring causing shortness of breath, infection, and fatal lung failure.
           2. (ii) Cataract formation in the eyes, possible loss of vision.
           3. (iii) Testicular damage in males causing sterility.
           4. (iv) Ovarian damage in females causing premature menopause and sterility.
           5. (v) Increased risk of second cancer.

19. (s) Endoscopic surgery.

    1. (1) Abdominal endoscopy/laparoscopy procedures. The following shall be in addition to risks and hazards of the same surgery when done as an open procedure.

       1. (A) Damage to intra-abdominal structures (e.g., bowel, bladder, blood vessels, or nerves).
       2. (B) Intra-abdominal abscess and infectious complications.
       3. (C) Trocar site complications (e.g., hematoma/bleeding, leakage of fluid, or hernia formation).
       4. (D) Conversion of the procedure to an open procedure.
       5. (E) Cardiac dysfunction.

    2. (2) Endoscopic surgery of the thorax. The following shall be in addition to risks and hazards of the same surgery when done as an open procedure.

       1. (A) Postoperative pneumothorax.
       2. (B) Subcutaneous emphysema.
       3. (C) Conversion of the procedure to an open procedure.

20. (t) Pain management procedures.

    1. (1) Neuroaxial procedures (injections into or around spine).

       1. (A) Failure to reduce pain or worsening of pain.
       2. (B) Nerve damage including paralysis (inability to move).
       3. (C) Epidural hematoma (bleeding in or around spinal canal).
       4. (D) Infection.
       5. (E) Seizure.
       6. (F) Persistent leak of spinal fluid which may require surgery.
       7. (G) Breathing and/or heart problems including cardiac arrest (heart stops beating).

    2. (2) Peripheral and visceral nerve blocks and/or ablations.

       1. (A) Failure to reduce pain or worsening of pain.
       2. (B) Bleeding.
       3. (C) Nerve damage including paralysis (inability to move).
       4. (D) Infection.
       5. (E) Damage to nearby organ or structure.
       6. (F) Seizure.

    3. (3) Implantation of pain control devices.

       1. (A) Failure to reduce pain or worsening of pain.
       2. (B) Nerve damage including paralysis (inability to move).
       3. (C) Epidural hematoma (bleeding in or around spinal canal).
       4. (D) Infection.
       5. (E) Persistent leak of spinal fluid which may require surgery.

Source Note:The provisions of this §601.2 adopted to be effective October 3, 1995, 20 TexReg 7486; amended to be effective October 23, 1997, 22 TexReg 10318; amended to be effective March 18, 2004, 29 TexReg 2646; amended to be effective November 28, 2004, 29 TexReg 10780; amended to be effective October 16, 2005, 30 TexReg 6435; amended to be effective March 4, 2007, 32 TexReg 902; amended to be effective January 16, 2012, 36 TexReg 8557.