Saint Francis Kidney Transplant Program Issue Date: 6/9/15

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1 Kidney Transplant Candidate Informed Consent Education Here are educational materials about Kidney Transplant. Please review and read these before your evaluation visit. The RN Transplant Coordinator will review these at that time, and ensure we answer any questions you may have about kidney transplant. Roles of the Transplant Team During this time, I will have tests/lab work done and I will meet with the members of the transplant team. This will help me decide if a transplant will be right for me. The Transplant Coordinator is a Registered Nurse that helps to guide me through the testing. The nurse will teach me what I need to do before and after my kidney transplant. This meeting will give me a chance to ask questions and will help me to understand what to expect. A Nephrologist is a doctor that treats kidney disease. This doctor will work with the transplant team to decide if I am able to handle a transplant. A Transplant Surgeon is the doctor that does the surgery. The transplant surgeons at Saint Francis Kidney Transplant Program are J. Steve Miller, MD, and Stephen Confer, MD. One of the surgeons will meet with me to discuss: if a transplant is right for me the types of kidneys that may be offered to me any problems from the surgery that I may have after I receive my kidney transplant. A Social Worker is a member of the transplant team that will meet with me to review my insurance coverage. The Social Worker will talk about the cost of medications I will take after kidney transplant and the support I may need. He/she will also assess my support to help determine if I can maintain a kidney transplant. A Transplant Financial Coordinator is a member of the transplant team who reviews my insurance coverage and outlines transplant specific coverage. Psychiatrist/Psychologist is a person who works with people who have special emotional needs. This could include depression, anxiety, and drug or alcohol use. I may be asked to see this person as part of my evaluation. A Dietitian is someone who is educated in diet, and weight control. The 1

2 Dietitian will talk with me to review my current weight and eating habits. After transplant, the Dietitian will work with me to maintain healthy weight and diet. Before my transplant, I will continue to work with the dietitian at the dialysis center. A Pharmacist is a member of the transplant team who will teach me about all of my medications and will help me get organized regarding taking my medications. The Transplant Pharmacist will also help me learn which medicines are safe for my new kidney and which are not. Appointments with other doctors may be needed in order to clear me for transplant. For example, I may need to be seen by a pulmonologist (lung doctor), or a cardiologist (heart doctor), etc. Alternative Treatments I understand that if I do not choose transplantation as treatment for my kidney disease. Other treatment choices are: 1. Remain (or begin) on dialysis 2. Stop all treatment I understand that I have the right to seek a second opinion at another transplant center of my choice. Insurance If I have my transplant at a hospital that is not approved by Medicare to do transplants, Medicare part B will not pay for my anti-rejection medications. With kidney disease, some health insurance companies may consider me to have a preexisting condition. They may refuse to pay for medical care, treatments or procedures until a specified time. Health and life insurance premiums may rise and remain higher. Insurance companies may also refuse to insure me. If I have a living kidney donor transplant, I am strongly encouraged to have Medicare My insurance / Medicare is billed for my donor s professional fees Any living donation complications are billed to my insurance / Medicare. If my donor has complications and I am not a Medicare beneficiary OR a direct correlation between my donor s complications and the donation surgery can not be proven, then all 2

3 bills will become my personal responsibility. Transplant Process A successful transplant does not come from the surgery alone. It also depends on how well I follow my doctor s orders. I need to be aware of the possible risks and problems that having a kidney transplant may cause. By having this surgery, there is the risk for serious injury or even death. The doctors cannot tell how my body will react to a kidney transplant, nor can they always predict how my original kidney disease will affect my new kidney. The overall success rate is about 92%. This means that the chances of losing my kidney from rejection or death after a kidney transplant is about 8% during the first year. Deceased donor kidneys are placed according to the policy of United Network for Organ Sharing (UNOS). These kidneys are placed based on how long the patient has been on the waiting list, how well the donor and the recipient match, and if the recipient is sensitized (difficult to find a compatible donor). Selection Criteria I understand that patient selection criteria must ensure fair and non-discriminating distribution of organs. To be a candidate for a kidney transplant I must meet the following criteria. Have irreversible kidney failure that requires dialysis or is approaching the need for dialysis. I understand this to be 20% or less of normal kidney function. I understand I must be free of chronic active infections. I can not have severe heart disease or other severe blood vessel disease. This means no blockages in my blood vessels that limit physical activity or put me at high risk for heart attack or losing a limb. Also, I can not have blockages that make it difficult for a surgeon to safely perform a transplant. I can not have severe liver or lung disease. No current cancer or a cancer that would be reactivated by the medicines needed to treat transplant patients. If I have had cancer, I will need to wait a determined length of time. I must be able to manage and understand, or have someone help me manage, the medical treatments that are needed to have a successful outcome after transplant. Since transplant is a treatment, not a cure, I understand the need for the medication, blood tests, and doctor visits for the rest of my life. I must not be severely obese, by having a body mass index (BMI) less than or equal to 35, and a waist circumference of less than or equal to 45 inches. I can not smoke or use any tobacco products 3

4 I can not be actively using street drugs or smoking marijuana. I can not have a mental illness that can t be treated. I understand the need for adequate insurance to cover the transplant and medication needed after transplant. I will need people available after transplant to provide care during recovery. This means having friends or family available 24 hours/day who can help drive me to and from appointments, help with home care or child care needs, assist me with my medications and medical care, and who can be there to assist me if I become ill. Evaluation Process I will need to have many tests done in order to help decide if I can have a transplant. Some of the tests will be done during my evaluation and others will be done if needed based on the previous test results. Blood tests: Blood type. Tissue type PRA Panel Reactive Antibodies Screen for current or previous viruses General blood work to determine my overall health Drug and alcohol screens (as indicated) Pregnancy test for women (as indicated) Prostate test for men over the age of 40 Pap smear, mammogram Colonoscopy (age 50 or older) Chest X-ray Heart Tests: EKG Or Cardiac Stress Test Ultrasound of my kidneys and abdomen will tell the size of my kidneys, and look for stones. CT scan: This test will be done if I need further evaluation of my abdominal organs. Lung function tests may be required if I have smoked in the past or have a history of lung disease. 4

5 Waiting Time Transfer and Multiple Listing Once I am listed for transplant, I have the option of listing at different centers. I also have the option to transfer any waiting time to a different transplant center without losing any waiting time I have earned. Notification When an organ becomes available, I will be called by the RN Transplant Coordinator to offer the kidney to me. Any risks associated with this organ will be made known. I always have the right not to accept the kidney offer and my position on the waiting list will not change. Potential Medical/Psychosocial Risks There are risks in all surgeries. Many problems are minor and get better on their own. In some cases, the problems are serious enough that another surgery or medical procedure may need to be done. Bleeding during or after surgery may require a blood or blood products transfusions. Blood products can contain viruses such as HIV and Hepatitis. However, this is rare due to screening of all blood products. Right after surgery, my new kidney may have delayed function. This delay may increase my hospital stay. It may be necessary to have a few dialysis treatments until my kidney starts working correctly. There is a possibility that the transplanted kidney may not work at all. When this happens, I will have to return to or begin dialysis. My doctors will then decide if another transplant is an option for me. There are other risks and associated problems with kidney transplants: My chance of getting infections is higher. These could be from fungus, bacteria, or viruses. These could include wound infections and pneumonia, or bladder infection. My body may possibly reject the kidney, even with treatment to prevent it. Side effects from the medications can range from mild to severe and may include tremors, bone disorders, and stomach problems. Women of child bearing age are advised to use birth control and notify the transplant team if I plan to become pregnant as the medications may increase my risk for miscarriage and birth defects. Additional information has been given to me if applicable. High blood pressure and/or problems controlling my blood pressure if it was 5

6 previously high. Weight gain. Diabetes. Slight increase for risk of certain kinds of cancer, including skin cancers. Depression during the recovery. Mental confusion associated with the medications. Death is possible due to cardiac problems or infections. Organ Donor Risk Factors There are certain risk factors that may affect the success of your transplant: The donor s past medical history The donor s past social history The length of time the organ is without blood flow. There is a possible risk that an infection has not been detected in the donor. This includes HIV and other infectious diseases. There is a risk of contracting these diseases. Surgical Procedure: I will be asked to sign a separate, full surgical consent prior to the transplant surgery. I understand that my blood type and the donor s blood type will be verified prior to surgery. If I have a living donor transplant these results will be maintained as part of the donor s transplant medical record, and will not be released. The surgical procedure(s) will be explained in terms that I understand, by J. Steve Miller, M.D. or Stephen Confer, MD, which includes: Risks associated with surgery. Possible need for blood transfusion and the risks involved with the use of blood or blood products. Expected post-surgical course and discomforts. Termination of the surgery with any indication that I may be at risk for complications during the surgery. 6

7 I understand that no assurance can be given that the procedure(s) will be successful. The Anesthesiologist is the doctor that puts me to sleep before surgery begins. He will meet with me to go over my current and past medical problems. The anesthesia doctor will talk more with me about the risks of anesthesia. During the transplant surgery, I will be put under general anesthesia. This means I will be given medications to put me to sleep and block pain. I will also be placed on a machine to help me breathe. The transplant surgeon will then make an incision into my abdomen. The donated kidney will be placed through this opening. This incision will be about 8-10 inches. Special mechanical boots or sleeves will be placed around my legs. These will help keep blood flowing through my legs and will help to prevent blood clots. Post-Surgical Care and Recovery I will go to the recovery room for a brief period after surgery. I will be taken to the transplant floor, where I will be watched closely. I will have a catheter to drain urine from my bladder. I might have a drain beside the incision to remove fluids and help me heal. I will have Intravenous (IV) fluids to keep me hydrated. The mechanical boots or sleeves will still be around my legs to keep blood clots from forming. I could be taken to the intensive care unit (ICU) for additional monitoring. I may have some pain right after surgery. This will be carefully controlled. This will diminish over time and is usually minimal 2-3 weeks after the surgery. My hospital stay will depend on how fast I recover. Most patients stay in the hospital 6-10 days. The hospital stay can depend on how sick I was before my transplant and if I have any problems after the surgery. A stent will be placed at the site where the kidney is attached to the bladder (ureteral stent.) This stent is usually removed within several weeks after transplant. After discharge: For the first 4-6 weeks after surgery, I will have some restrictions on the things that I can and cannot do. If I have any problems, the recovery time may be longer. 7

8 During this recovery period, the transplant team and my Nephrologist will watch me closely. I must follow the treatment plan outlined by the transplant team: I must be able to come for blood work or other tests, as directed by my Post- Transplant Clinic team, to see how well my transplanted kidney is working. If my body starts to reject the transplanted kidney, a biopsy may be needed. I will take medications as prescribed. I will have my medications refilled at the right time so that I do not ever run out. I will help to keep my weight under control. I will notify the transplant center of any signs of infection. National and Transplant Center-Specific Outcomes Statistics from the Scientific Registry of Transplant Recipients (SRTR) (www.srtr.org) have been shared with me and my questions have been answered. Notification of Medicare Outcome Requirements not being met by Center I have been told that Transplant centers are required to meet certain guidelines and are required to notify me if they do not meet these guidelines. I have been told that Saint Francis Kidney Transplant Program is a Medicare approved Transplant Center. Availability of Customary Kidney Transplant services: I have been told that the following essential services are available 24 hours per day, 7 days per week, and 365 days per year: Kidney Transplant surgeon RN Kidney Transplant Coordinator Tissue typing laboratory services Transplant Nephrologist Dialysis services Organ Procurement services I understand that I will be notified by phone and in writing if there are changes to the program s customary services that would affect my ability to receive a transplant should an organ become available. 8

9 Donor Options You have the right to refuse a particular organ for kidney transplantation without adverse consequences regarding your status on the waiting list. You also have the right to refuse a kidney transplantation altogether. Refusal to receive a certain organ will not adversely affect your status on the organ waiting list, and you will remain a candidate for transplantation using other donor organs. 1) Living Donor Kidney A kidney from a living donor, who has been evaluated by a medical team and has two functioning kidneys without medical evidence of renal disease. In some cases, one of the kidneys may have multiple vessels, history of renal stone, or a medical condition that could potentially increase the risk of renal transplantation. 2) Deceased Donor Kidney A kidney from a deceased donor, who was declared brain dead based on a lack of brain function. 3) Donor from Cardiac Death (DCD) A kidney from a deceased donor, who was declared dead based on a lack of a heartbeat. All organs require oxygen to survive. When a donor is declared dead without a heartbeat, the kidney may be damaged due to a lack of oxygen prior to recovery and preservation. These kidneys are less likely to function immediately and may have a greater risk of rejection. 4) KDPI > 85% A kidney with a KDPI >85% (Kidney Donor Index Profile) that has a percentage score > 85% are expected to function for a shorter time than those with lower KDPI. Kidneys in this category have a higher chance of not working immediately, however many of them will have a good long-term function. Being listed for a kidney with a KDPI >85% does not put you at disadvantage for receiving offers of kidneys with KDPI less than 85%, but may allow you to be transplanted more quickly and reduce the length of time that you require dialysis. The score is based on 10 organ donor factors: *Age *Whether donor died due to loss of *Serum Creatinine *Height heart function or loss of brain function *History of diabetes *Weight *Stroke as a cause of death *Exposure to Hep C *Ethnicity *History of high blood pressure Concerns or Grievances I have been told that United Network for Organ Sharing (UNOS) has a toll-free patient services line at Transplant patients and family members may call to discuss any questions or concerns that they may have about the transplant system, organ placement, as well as their personal care. 9

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