B9

Department of Health and Human Services OMB No. 0915-0184

Health Resources and Services Administration Expiration Date:  xx/xx/201x

Part 4: Living Donor Recoveries

Complete this section if applying for initial approval for living donor recoveries.

It is recognized that in the case of pediatric living donor recoveries, the living organ donation may occur at a hospital that is distinct from the approved transplant hospital. If this program performs pediatric transplants, list any other hospitals where the donor evaluation and surgery may routinely occur.

Hospital Name	Location

PART 4: Section 1 - Other Staff and Resources

1. How does the hospital assess that the short and long term risks for the potential living donor are acceptable to the medical staff at the transplant hospital and the donor? The response needs to address the following: evaluation, consent, surgical risk, and long-term donor considerations.

[Insert response here, table will expand automatically.]

2. Mental Health and Social Support Services: Identify the designated members of the transplant team who have primary responsibility for coordinating the psychosocial needs of living donors. Describe their role in this process. (Insert rows as needed.)

Name	Role in Providing Support to Living Donors

3. Does the program have the ability to perform a psychosocial assessment of the donor to:

	Yes	No
Make an informed decision?
Affirm voluntary nature of proceeding with the evaluation and donation?

4. Describe how the program meets the requirement for having an Independent Donor Advocate (IDA) who is not involved with the potential recipient evaluation and who is independent of the decision to transplant the potential recipient.

[Insert response here, table will expand automatically.]

Part 4, Section 2: Living Donor Recoveries – Protocols

Transplant programs that perform living donor recoveries must demonstrate that they have written protocols as listed below. Submission of actual protocol is not required as a part of this application.

Written protocols must address at a minimum the areas listed below:	Included in Protocol?
	Yes	No
Protocols addressing all phases of living donation process: Evaluation Pre-Operative Operative Post-Operative care Submission of follow up forms
IDA – descriptions of duties and responsibilities: Promotes the best interests of the potential living donor Advocates the rights of the potential living donor Assists the potential donor in obtaining and understanding information regarding the consent process, evaluation process, surgical procedure, and benefit and need for follow-up
Medical evaluation by a physician and/or surgeon experienced in living donation to: Assess and minimize risks to the potential donor post-donation, which shall include a screen for any evidence of occult renal and infectious disease and medical co-morbidities, which may cause renal disease
Psychosocial Evaluation of the potential living donor by a psychiatrist, psychologist, or social worker with experience in transplantation to: Determine decision making capacity Screen for any pre-existing psychiatric illness Evaluate any potential coercion
Screening for evidence of transmissible diseases such as cancers and infections
Anatomic assessment of the suitability of the organ for transplant purposes
Informed Consent for Donor Evaluation Process: Discussion of the potential risks of the procedure including the medical, psychological, and financial risks associated with being a living donor Assurance that all communication between the potential donor and the transplant center will remain confidential Discussion of the potential donor’s right to opt out at any time during the donation process Discussion that the medical evaluation or donation may impact the potential donor’s ability to obtain health, life, and disability insurance Disclosure by the transplant center that it is required, at a minimum, to submit living donor follow-up forms addressing the health information of each living donor at 6 months, one-year, and two-year post donation. The protocol must include a plan to collect the information about each donor Documentation of disclosure to donor candidate by the hospital that it is unlawful to sell or purchase human organs
Describe how the hospital will assess compliance with each protocol listed above:

Part 4, Section 3: Kidney Paired Donation (KPD)

1. Will this program participate in the Kidney Paired Donation (KPD) program? If yes, please indicate which matching service will be used.

Yes	No
[Insert detailed response here. Table will expand automatically]

Version Pending Living Donor Recoveries - 2