UNC HOSPITALS CHAPEL HILL, NORTH CAROLINA 27514 REQUEST AND AUTHORIZATION FOR COLONOSCOPY, BIOPSY, AND POLYPECTOMY MIM#182 I request and authorize and/or associates or assistants of his/her choice at the University of North Carolina Hospitals to perform a colonoscopy and biopsies on. Authorization also is Patient s Name given for the control of bleeding, removal of abnormal growths, and dilation of abnormal areas of narrowing of the gastrointestinal tract. If the procedure is performed under the supervision of an attending physician, I understand that residents and/or assistants of his/her choice at the University of North Carolina Hospitals may perform selected tasks, which may include: opening and closing a surgical site; dissecting tissue; removing tissue, blood or body fluids; injecting medication(s); administering anesthesia; implanting devices; inserting/removing/operating an endoscope for diagnosis or treatment; and placing invasive lines. At the time of the procedure, the attending physician will determine the extent of participation by the resident(s) and/or assistant(s) depending on: (1) the complexity of the procedure; (2) the unique circumstances of the patient; and (3) the training and experience of the resident(s) and/or assistant(s). Description of the Procedure: The colonoscopy will involve the insertion of a long, flexible, video/fiberoptic instrument called a colonoscope into my rectum. The colonoscope will allow providers to view and examine the lining of my entire large intestine. If any abnormalities are seen, a biopsy may be performed. A biopsy involves the removal of one or more small samples of tissue through the colonoscope, which will be examined by a pathologist. If a growth or polyp is discovered, it will be removed to the extent deemed safe and possible, using a wire loop and electrocautery, or a forcep and electrocautery. An electrocautery is an instrument that directs a high frequency electrical current through an area of tissue. Treatment procedures may be performed if colonoscopy identifies a source of recent active bleeding or a narrowing of my digestive tract. These procedures may include treating the site of bleeding with an electrocautery, laser, heater probe and/or injection of agents that cause blood to clot. Narrowed areas of the gastrointestinal tract may be enlarged by the use of balloons or tapered tubes of varied sizes. I understand that sedatives, such as Versed, Demerol, Droperidol and/or Morphine, will be given by intravenous line to cause relaxation and drowsiness. These 2/97 1 of 4
medications also may cause a brief period of memory loss and result in my not having a recollection of the procedure. Many patients sleep through the procedure, which typically takes 30 to 90 minutes. Risks: The following risks have been associated with a colonoscopy. 1. Slowing of breathing and abnormal heart rhythms. Intravenous medications may cause a slowing of breathing and, in rare cases, may cause breathing to stop. They also may cause lowering of blood pressure and/or abnormal heart rhythms. I will be carefully monitored for changes in my breathing, blood pressure and heart rhythms during and after the colonoscopy. 2. Perforation of the colon. A perforation or tear in the colon wall occurs in up to 4 per 1,000 colonoscopies. If a polyp is removed during the procedure, the risk of a perforation is 10 per 1,000 procedures. Perforations are treated with antibiotics and/or surgery, which could require a colostomy. 3. Bleeding. Bleeding may follow a biopsy or removal of a growth and may occur immediately or up to 2 weeks after the procedure. If a polyp is removed during the procedure, the risk of bleeding is 25 per 1,000 colonoscopies. Cases of excessive bleeding may require a blood transfusion, repeat colonoscopy, or surgery. 4. Injury to the spleen. Injury to the spleen has rarely been reported. 5. Infection. Patients with heart murmurs or artificial heart valves may be given antibiotics before a colonoscopy in order to reduce the risk of infection of the heart valves. 6. Other complications. Patients may rarely experience an unexpected, adverse drug reaction. Other possible complications of a colonoscopy include: inflammation, mild abdominal discomfort, injury to internal organs and bruising or infection at the intravenous site. 7. Death. Death as a complication of colonoscopy is extremely rare, but has been reported to follow a colonoscopy in 1 per 10,000 procedures, and 2 per 10,000 procedures in which a polyp was removed. 8. Missed abnormalities. Some growths and even some cancers are not seen during colonoscopy. This may occur if the colon is not completely clean, if there are blind areas in the colon, or if the 2/97 2 of 4
exam cannot be completed. Inability to complete the exam occurs in fewer than 5 per 100 colonoscopies. Benefits: I understand that the purpose of a colonoscopy is to gain information about the entire large intestine that may not be obtained by x-ray or by other diagnostic means, and to treat certain conditions. The procedure is generally very safe and is well tolerated by most patients. Alternative Options: I understand that x-rays and surgery are the alternatives to a colonoscopy. Statement of Voluntary Participation: I have read the information contained in this form, and have had sufficient opportunity to discuss my medical condition and treatment with the undersigned health care provider. All of my questions have been answered to my satisfaction, and I believe that I have been given adequate information upon which to base an informed consent for a colonoscopy, biopsy, and other possible therapeutic procedures. I am consenting to have a colonoscopy, biopsy, and other possible therapeutic procedures performed. I understand that I can withdraw my consent at any point. My consent for this procedure is voluntary. I understand that during the course of the colonoscopy something unexpected may arise which may necessitate procedures in addition to or different from those described above. If such unexpected circumstances arise I further request and authorize the performance of additional operations or procedures that may be considered necessary or advisable by the undersigned health care provider and/or his/her associates or assistants. I further request that the administration of such anesthetics as may be considered necessary, desirable, or advisable by the provider responsible for this service. Risks included with the administration of anesthesia or sedation analgesia include: severe blood loss, infection, damage to teeth, mouth, throat or vocal cords, nerve or eye damage, drug reaction, slowing or stopping of breathing, failure of the anesthetic or sedation analgesia, cardiac arrest, risks that cannot be predicted, permanent disability or even death. I understand these risks and I consent to the use of any anesthetic or sedation analgesia that my health care providers or the anesthetists believe is necessary. Do Not Resuscitate Orders: I understand that, if I/the patient have a Do Not Resuscitate (DNR) Order currently in effect, it will be suspended temporarily before, during and immediately after the therapy I/the patient will be undergoing unless I place my initials in the following space. Administration of Blood or Blood Products: I have discussed with my health care provider the possibility of administering blood or blood products before, during or after the operation or procedure during my current admission, or for the duration of planned 2/97 3 of 4
treatment up to one year, as long as my medical condition and proposed treatment and associated risks have not changed. I understand that I/the patient will be given medically necessary blood and blood products unless I place my initials in the following space. I am aware that the practice of medicine is not an exact science, and I acknowledge that no guarantees have been made concerning the performance, results, or interpretation of the colonoscopy. For the purpose of advancing medical education I give my permission for observers to be admitted to the operating room or procedure room, and for UNC Hospitals and the UNC School of Medicine staff to make and use any photographic or other illustrations of me for diagnostic, scientific, educational, or research purposes, provided that my identity is not revealed. I further authorize UNC Hospitals and the UNC School of Medicine staff to examine and dispose of any tissues or parts that may be removed and to use them for teaching, educational, or research purposes, provided that my identity is not revealed. I confirm that I have read this form, or it was read to me, and that all blank spaces were filled in and all inapplicable paragraphs, if any, were stricken before I signed below. Signature of Patient/Person Authorized to Sign for Patient Date & Time: Printed Name Hospital Number Relationship to Patient PROVIDER CERTIFICATION I hereby certify that the nature, purpose, benefits, usual and most frequent risks of, and alternatives to, the proposed colonoscopy, biopsy, and other possible therapeutic procedures have been explained to the patient (or person authorized to sign for the patient) either by a physician or by the provider who is to perform the procedure(s), that the patient has had an opportunity to ask questions, and that those questions have been answered. The patient or the patient s authorized representative has been advised that selected tasks may be performed by assistants to the primary health care provider(s). I believe that the patient (or person authorized to sign for the patient) understands what has been explained, and has consented to the operation or procedure. Provider Signature Provider Name Date: 2/97 4 of 4
WITNESS CERTIFICATION I hereby certify that the patient (or person authorized to sign for the patient) has EITHER (Check one box): 1. Acknowledged in my presence that he/she has requested a colonscopy, biopsy, and other possible therapeutic procedures and has received an explanation of the nature, purpose, benefits, usual and most frequent risks of, and alternatives to, the operation or procedure, understands that selected tasks may be performed by the health care provider s assistants/residents, has had all of his/her questions answered, has given his/her consent, and has signed the form above; OR 2. Answered "yes" to all of the following questions: a. Did a health care provider explain the operation or procedures to you? b. Did a health care provider explain that selected tasks may be performed by assistant(s)/resident(s)? c. Did a health care provider explain alternative procedures and treatments and their risks and benefits? d. Is this your signature on the consent form? e. Have you given your consent for the operation or procedures? f. Have all of your questions about the operation or procedures been answered? Witness Signature Witness Name Date & Time: 2/97 5 of 4