Please check appropriate box: Right Left Bilateral Not Applicable

Transcription

1 Patient Label Here UNIVERSITY MEDICAL CENTER DISCLOSURE AND CONSENT - MEDICAL AND SURGICAL PROCEDURES TO THE PATIENT: You have the right as a patient to be informed about your condition and the recommended surgical, medical or diagnostic procedure to be used so that you may make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. This disclosure is not meant to scare or alarm you; it is simply an effort to make you better informed so you may give or withhold your consent to the procedure. 1. I (we) voluntarily request Doctor(s) as my physician(s), and such associates, technical assistants and other health care providers as they may deem necessary to treat my condition which has been explained to me (us) as (lay terms): Heart failure 2. I (we) understand that the following surgical, medical, and/or diagnostic procedures are planned for me and I (we) voluntarily consent and authorize these procedures (lay terms): Ventricular Assist Device Implantation Please check appropriate box: Right Left Bilateral Not Applicable 3. I (we) understand that my physician may discover other different conditions which require additional or different procedures than those planned. I (we) authorize my physician, and such associates, technical assistants and other health care providers to perform such other procedures which are advisable in their professional judgment. 4. I (we) (do) (do not) consent to the use of blood and blood products as deemed necessary. I (we) understand that the following risks and hazards may occur in connection with the use of blood and blood products: a. Serious infection including but not limited to Hepatitis and HIV which can lead to organ damage and permanent impairment. b. Transfusion related injury resulting in impairment of lungs, heart, liver, kidneys and immune system. c. Severe allergic reaction, potentially fatal. 5. I (we) understand that no warranty or guarantee has been made to me as to the result or cure. 6. Just as there may be risks and hazards in continuing my present condition without treatment, there are also risks and hazards related to the performance of the surgical, medical, and/or diagnostic procedures planned for me. I (we) realize that common to surgical, medical and/or diagnostic procedures is the potential for infection, blood clots in veins and lungs, hemorrhage, allergic reactions, and even death. I (we) also realize that the following hazards may occur in connection with this particular procedure: Pain, right ventricular failure, left ventricular failure, dysrhythmias, arrhythmia, hypertension, organ failure, stroke, hemolysis, heart attack, mechanical pump failure, liver dysfunction, kidney failure, low blood count, constipation, abdominal cramping, skin bruising, muscle weakness, neurological dysfunction, pulmonary dysfunction, need for mechanical ventilation, failure of procedure, need for further procedures 7. I (we) understand that Do Not Resuscitate (DNR), Allow Natural Death (AND) and all resuscitative restrictions are suspended during the perioperative period and until the post anesthesia recovery period is complete. All resuscitative measures will be determined by the anesthesiologist until the patient is officially discharged from the post anesthesia stage of care. Page 1 of 2

2 UNIVERSITY MEDICAL CENTER Ventricular Assist Device (cont.) Patient Label Here 8. I (we) authorize University Medical Center to preserve for educational and/or research purposes, or for use in grafts in living persons, or to otherwise dispose of any tissue, parts or organs removed except None 9. I (we) consent to the taking of still photographs, motion pictures, videotapes, or closed circuit television during this procedure. 10. I (we) give permission for a corporate medical representative to be present during my procedure on a consultative basis. 11. I (we) have been given an opportunity to ask questions about my condition, alternative forms of anesthesia and treatment, risks of non-treatment, the procedures to be used, and the risks and hazards involved, potential benefits, risks, or side effects, including potential problems related to recuperation and the likelihood of achieving care, treatment, and service goals. I (we) believe that I (we) have sufficient information to give this informed consent. 12. I (we) certify this form has been fully explained to me and that I (we) have read it or have had it read to me, that the blank spaces have been filled in, and that I (we) understand its contents. If I (we) do not consent to any of the above provisions, that provision has been corrected. I have explained the procedure/treatment, including anticipated benefits, significant risks and alternative therapies to the patient or the patient s authorized representative. A.M. (P.M.) Date Time Printed name of provider/agent Signature of provider/agent A.M. (P.M.) Date Time *Patient/Other legally responsible person signature Relationship (if other than patient) *Witness Signature Printed Name UMC 602 Indiana Avenue, Lubbock, TX TTUHSC th Street, Lubbock, TX OTHER Address: Address (Street or P.O. Box) City, State, Zip Code Interpretation/ODI (On Demand Interpreting) Yes No Date/Time (if used) Alternative forms of communication used Yes No Printed name of interpreter Date/Time Date procedure is being performed: Page 2 of 2

3 UNIVERSITY MEDICAL CENTER Date Patient Label Here Resident and Nurse Consent/Orders Checklist Instructions for form completion Note: Enter not applicable or none in spaces as appropriate. Consent may not contain blanks. Section 1: Enter name of physician(s) responsible for procedure and patient s condition in lay terminology. Specific location of procedure must be indicated (e.g. right hand, left inguinal hernia) & may not be abbreviated. Section 2: Enter name of procedure(s) to be done. Use lay terminology. Section 3: The scope and complexity of conditions discovered in the operating room requiring additional surgical procedures should be specific to diagnosis. Section 5: Enter risks as discussed with patient. A. Risks for procedures on List A must be included. Other risks may be added by the Physician. B. Procedures on List B or not addressed by the Texas Medical Disclosure panel do not require that specific risks be discussed with the patient. For these procedures, risks may be enumerated or the phrase: As discussed with patient entered. Section 8: Enter any exceptions to disposal of tissue or state none. Section 9: An additional permit with patient s consent for release is required when a patient may be identified in photographs or on video. Provider Attestation: Patient Signature: Witness Signature: Performed Date: Enter date, time, printed name and signature of provider/agent. Enter date and time patient or responsible person signed consent. Enter signature, printed name and address of competent adult who witnessed the patient or authorized person s signature Enter date procedure is being performed. In the event the procedure is NOT performed on the date indicated, staff must cross out, correct the date and initial. If the patient does not consent to a specific provision of the consent, the consent should be rewritten to reflect the procedure that the patient (authorized person) is consenting to have performed. Consent For additional information on informed consent policies, refer to policy SPP PC-17. Name of the procedure (lay term) No blanks left on consent Right or left indicated when applicable No medical abbreviations Orders Procedure Date Diagnosis Procedure Signed by Physician & Name stamped Nurse Resident Department THIS FORM IS NOT PART OF THE MEDICAL RECORD

4 UNIVERSITY MEDICAL CENTER UMC/TTUHSC INFORMED CONSENT FOR VENTICULAR ASSIST DEVICE THERAPY FOR HEART FAILURE Patient Label Here Consent Form The following information is provided in order to help inform you of the ventricular assist device (VAD) implantation procedure including the purpose, treatment, course, and potential risk and heart benefits. If you have any question, please do not hesitate to ask. You have been diagnosed with heart failure and a ventricular assist device is being considered for your treatment plan. You should understand the risk and benefit enough to make an informed judgment. This consent gives you detailed information about the process and the team. You have the right to discuss any part of the process with the team at any time. Once you have read the consent and had all your questions answered you will be asked to sign the form if you wish to proceed. Purpose You have been diagnosed as having heart failure and your heart is too weak to pump. The VAD can assist your weak heart to pump enough blood to your body s organs and tissues. This pump may make you feel better and offer a better quality of life. The following document is being provided to explain and inform you of different aspects of mechanical support device service of which you may not be aware. Surgery to implant can be quite demanding physically, psychologically and financially. In order to meet these demands, we have developed this outline of responsibilities and necessary resources. SELECTION CRITERIA FOR VENTICULAR ASSIST DEVICE DESTINATION THERAPY The following information on selection criteria has been provided for you if you are a candidate for VAD destination therapy. Inclusion criteria: o Chronic end stage heart failure with end stage left ventricular failure with life expectancy of less than two years o New York Heart Associations Class IV heart failure symptoms with failure to respond to optimal medical management o Left ventricular ejection fraction (LVEF) less than 25% o Demonstrated functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min o Continued need for intravenous inotropic therapy o Not a candidate for heart transplantation o Anticipated survival benefit with VAD implantation Exclusion criteria include: o No condition that would otherwise reduce their life expectancy o Sepsis or active infection o Active mental illness or psychosocial instability o Absence of consistent or reliable social support system o History of chronic non compliance RIGHT OF REFUSAL If for any reason you do not wish to continue with these tests and be considered for transplantation, VAD placement, or if you have questions about the evaluation, please let the nurse coordinator know and testing will be terminated without bias. We will assist you with information regarding alternative therapies if available. If there are any changes in your health please notify the VAD office at (806) Page 3 of 5

5 Patient Label Here UNIVERSITY MEDICAL CENTER THE SURGICAL PROCEDURE The surgical procedure takes three to six hours. A general anesthesia is used. The risks of a general anesthesia are small but may include drug reactions. Patients undergo the procedure called mechanical support device implantation. This procedure is when a tube is placed in the left ventricle with a special connection technique to drain the blood out of the left ventricle to be pumped through the mechanical device. Another tube is placed on the other side of the mechanical device to send the blood back to the aorta for circulation to the body. A power supply cord is then tunneled through the abdominal wall to the surface for connection to the battery supply. Complication of mechanical assist device placement can be the same experience as a patient receiving coronary bypass surgery and hemorrhage, Right ventricular failure, left ventricular failure, Dysrhythmias, infection, hypertension, organ failure, stroke, infection, and death. THE RISKS OF MECHANICAL ASSIST DEVICE IMPLANTATION Mechanical Assist Device Implantation is not without risks. There is a small chance of death during the procedure. The device is not a guarantee that you will feel better than you do now, although the vast majority of patients do feel much better. Side effects can occur from the procedure. These can include hemorrhage, high blood pressure, low blood counts, constipation, abdominal cramping, easy skin bruising, muscle weakness, infection. The psychosocial risks could be: depression, mood swings, and problems with family coping, guilt, and financial difficulties, just to name a few. THE ALTERNATIVES TO MECHANICAL ASSIST DEVICE PLACEMENT There are alternatives to Mechanical Assist Device Placement available to you. Mechanical Assist Device Placement is not a cure for your heart disease but a form of treatment. Other forms of therapy include continued medical management of heart failure symptoms. For details of forms of therapy please talk to your heart specialist. It is also possible to refuse all treatment which will result in death. EXPECTATIONS Part of the expectation of your undergoing VAD implantation is that you must have a primary support person with you are discharged from the hospital. The support person will be expected to be with you 4-6 weeks following your device implant and to be willing to provide additional support when necessary throughout your implant course. The support person will have to become proficient in the device operation and emergency measures and for becoming proficient in the device operation and emergency situation until you arrive at University Medical Center Hospital for further treatment. They will be responsible for seeing that you have meals, follow your prescribed treatment plan, medication and have transportation to all appointments. You will not be permitted to drive following your VAD implant in effort to assure your safety as well as the safety of others in the event of a medical emergency related to the device. CONFIDENTIALITY We are required by law to maintain the privacy/confidentially of your health information. All information that is obtained in connection with this procedure, which is linked to you, will remain as confidential as possible within the requirements of state and federal law. The results of this procedure will be reviewed and published in medical literature and journals without identifying you by name. I f the data is used for publication in the medical literature or for teaching purposes your name will not be used. Records will be kept regarding this procedure and will be made available for required audits/ reviews by representatives of the Food and Drug Administration (FDA) and the UNOS (United Network of Organ Sharing). These organizations have guidelines in which we are required to meet and maintain. Their reviewers have access to your medical records however they are governed by the same confidentiality rules we are. Your insurance company may also review your record. During the discharge planning process, your name, demographics, and medical condition will be released to your electrical company and any medical personnel involved in your care after your discharge home. This may include home care agencies, cardiac rehabilitation facilities, and emergency response teams such as fire and emergency departments. Page 4 of 5

6 Patient Label Here UNIVERSITY MEDICAL CENTER PROGRAM COVERAGE The UMC adult Heart Transplant VAD Program has coverage of surgeon(s) and physician(s) and a VAD coordinator 365 days a year 24 hours a day 7 days a week to provide services to our patients. This is with compliance of UNOS Bylaws. If there is any substantial change in our program coverage you will be notified in writing. I have read the above and all questions have been answered by a member of the VAD team to my satisfaction. Patient signature Date/Time Witness Date/Time Page 5 of 5