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Policies,Administrative,UWHC,Department Specific,Transplant,Transplant - Solid Organ

Patient Consent Process (3.06)

Patient Consent Process (3.06) - Policies, Administrative, UWHC, Department Specific, Transplant, Transplant - Solid Organ

3.06



POLICY & PROCEDURE
Effective Date: June 2007
Revised Date: June 2015 Title: Patient Consent Process Policy Number: 3.06

Page 1 of 3
I. PURPOSE

The purpose of this policy is to ensure patients are being provided with clear and understandable
information to allow them to make an informed decision at the time of evaluation or prior to
transplantation, as well as to comply with regulatory agencies.


II. POLICY

It is the policy of the UW Transplant program to adhere to the University of Wisconsin Hospital and Clinics
(UWHC) standards of patient care, as well as the standards determined by regulatory and accrediting
agencies, such as The Joint Commission, the Organ Procurement and Transplantation Network (“OPTN”)
and the United Network of Organ Sharing (“UNOS”) and the Centers for Medicare and Medicaid Services
(“CMS”), and any State and Federal laws.


III. FORMS

Patient Consent Forms contain information regarding risks and benefits, UNOS required criteria such as
multiple listing option, CMS required criteria such as 1-year outcomes and waiting times. The following
forms can be found on the “related tab” for this policy:
1. Liver Transplant Consent - Spanish Version
2. Kidney Transplant Consent - Spanish Version
3. Solitary Pancreas or Simultaneous Kidney and Pancreas Consent
4. Kidney ECD Consent
5. Liver DCD Consent
6. Living Kidney Donor Consent
7. Living Liver Donor Consent
8. Heart Transplant Consent
9. Lung Transplant Consent
10. Transplant- DCD for Lung Consent Form (300612-DT)
11. Transplant- Intestine-Multivisceral Evaluation (301412-DT)
12. Transplant- Consent for Increased Risk Donors (301230-DT)
13. Consent to Operations-Liverbx (1289139-Liverbx)
14. Authorization and Consent Liver Transplant (301209-DT)
15. Authorization and Consent Kidney Transplant (301208-DT)



POLICY & PROCEDURE
Effective Date: June 2007
Revised Date: June 2015 Title: Patient Consent Process Policy Number: 3.06

Page 2 of 3


IV. PROCEDURE

1. The physician/surgeon or advanced practice provider participating in the patient evaluation process
will be responsible for reviewing and signing the initial patient consent form(s).
2. Throughout the evaluation process and prior to transplantation/donation, the transplant
coordinator will confirm that the patient has received a copy of the appropriate consent form(s) for
review and discussion. The coordinator will review patient understanding of the information
contained in the consent form(s) during the transplant process.
3. The Independent Living Donor Advocate will verify understanding of the consent form with all
potential living donor patients.
4. If a patient changes their decision regarding organ criteria outside of the evaluation visit and any
subsequent visits (i.e. over the telephone), the risks/benefits of the decision will be reviewed and
the discussion will be documented in the electronic medical record. The patient will be
given/mailed a new consent form to sign. Transplant coordinators may sign as the witness to
changes in the patient’s decision about organ criteria. A transplant surgeon/physician or advanced
practice provider will sign the consent. Transplant coordinators are responsible for ensuring updates
have been made in UNet.
5. The consent process for organs from donors classified as Increased Risk is handled per policy 3.10.
6. The consents for the transplant surgery will be obtained when the patient is admitted to the
hospital for their transplant. (See forms)
7. The signed consent(s) is valid until the time of organ transplant.
8. All consent form(s) will be scanned into the EMR (Electronic Medical Record).

V. REFERENCES

Organ Procurement Transplantation Network/United Network of Organ Sharing (OPTN/UNOS) Policies
located at www.optn.org or www.unos.org
Centers for Medicare & Medicaid Services (CMS) General Requirements for Transplant Centers, section
482.102.








POLICY & PROCEDURE
Effective Date: June 2007
Revised Date: June 2015 Title: Patient Consent Process Policy Number: 3.06

Page 3 of 3

VI. COORDINATION

University of Wisconsin Transplant Program


VII. REVIEWED AND APPROVED BY

Kidney Transplant Manager
Liver Transplant Manager
Heart and Lung Transplant Manager
Operations Director


VIII. SIGNED BY


________________________________ _________________________________
Jill Ellefson, MBA Dixon Kaufman, M.D., PhD
Director, Organ Donation and Transplant Service Line Chair, UW Transplant Program