OPTN Evaluation Plan - Organ Procurement and Transplantation ...

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Policy 14.3.A.ii: Living Kidney Donor Informed Consent RequirementsEffective Date: 2/1/2014At Living Donor recovery hospitals, site surveyors will:OPTN Member Evaluation PlanUpdated January 1, 2015Interview relevant staff, and substantiate the information obtained in the interview through review of internal policies, procedures and/or protocols; a sample of living donor medical records; or any material incorporated intothe medical record by reference to obtain evidence that the hospital's standard practice is:⦁ To provide information to donors in a language in which the donor is able to engage in a meaningfuldialogue with the recovery program staffReview a sample of living donor medical records, and any material incorporated into the medical record byreference, for documentation of written assurance from the donor that the donor:⦁ Is willing to donate⦁ Is free from inducement or coercion⦁ Has been informed that he/she may decline to donate at any timeReview a sample of living donor medical records, and any material incorporated into the medical record byreference, for documentation that the recovery hospital provided information or disclosure to the donor stating that:⦁ The recovery hospital will take all reasonable precautions to provide confidentiality for both:⦁ The donor⦁ The recipient⦁ It is a federal crime for any person to knowingly acquire, obtain, or otherwise transfer any human organ foranything of value⦁ That the hospital must (or will) provide an ILDA⦁ When the recipient transplant hospital is known (or is the same as the recovery hospital):⦁ SRTR's national 1-year kidney recipient patient and graft survival rates⦁ SRTR's most recent center-specific 1-year kidney recipient patient and graft survival rates for therecipient's transplant hospital⦁ On average, donors will have a 25-35% permanent loss of kidney function at donation⦁ Baseline risk of ESRD for donors does not exceed that of members of the general population with the samedemographic profile⦁ Donor risks must be interpreted in light of the known epidemiology of both CKD and ESRD. When CKD orESRD occur, CKD generally develops in mid-life (40-50 years old) and ESRD generally develops after age 60⦁ The medical evaluation of a young potential donor cannot predict lifetime risk of CKD or ESRD⦁ Donors may be at a higher risk for CKD if they sustain damage to the remaining kidney⦁ The development of CKD and subsequent progression to ESRD may be more rapid with only one kidney⦁ Dialysis is required if the donor develops ESRD⦁ Priority is given to prior living kidney donors who become kidney transplant candidates⦁ A deceased donor kidney might become available for the recipient before the donor evaluation iscompleted or the living donor transplant occurs⦁ Any transplant candidate might have risk factors for increased morbidity or mortality that are not disclosedto the potential donor⦁ The donor will receive a medical evaluation⦁ The donor will receive a psychosocial evaluation28
OPTN Member Evaluation PlanUpdated January 1, 2015⦁ The health information obtained during the evaluation will be subject to the same regulations as all medicalrecords⦁ The medical evaluation could reveal conditions that must be reported to public health authorities⦁ The recovery hospital is required to:⦁ Report living donor follow-up information at six months, one year, and two years post-donation.⦁ Any infectious disease or malignancy pertinent to acute recipient care discovered during the first two yearsof the donor's post-operative follow-up care:• Will be disclosed to the donor• May need to be reported to local, state or federal public health authorities• Will be disclosed to their recipient’s transplant center• Will be reported through the Secure Enterprise℠ Improving Patient Safety PortalRecovery hospitals will provide:The requested sample of living donor recordsThe recovery hospital's internal policies, procedures and protocols for the care of living donorsEvidence as needed to verify complianceAccess to relevant staff who can answer interview questionsPolicy 14.4.A: Living Donor Blood Type DeterminationEffective Date: 2/1/2014At Living Donor recovery hospitals, site surveyors will:Review a sample of living donor medical records, and any material incorporated into the medical record byreference, for documentation that there are results for:⦁ Two separately completed blood type tests, and⦁ That the two separately completed blood type tests are based on two separate blood samples drawn atdifferent times prior to recoveryRecovery hospitals will provide:The requested sample of living donor recordsEvidence as needed to verify compliance29
Page 1 and 2: OPTN Member Evaluation PlanUpdated
Page 3 and 4: Policy 8.5.A: Candidate Classificat
Page 9 and 10: Policy 2.8: Required Deceased Donor
Page 11 and 12: Policy 2.11.B: Required Information
Page 17 and 18: Policy 6.1.A: Adult Heart Status 1A
Page 21 and 22: Policy 8.5.E: Allocation of Kidneys
Page 25 and 26: Policy 9.3.H: MELD/PELD Score Excep
Page 27 and 28: Policy 13.2: Potential KPD Donor Re
Page 31: OPTN Member Evaluation PlanUpdated
Page 35 and 36: Policy 14.4.B: Living Kidney Donor
Page 37 and 38: ⦁ Personal history of:⦁ Hyperte
Page 47 and 48: Policy 18.5.A: Reporting Requiremen
Page 49 and 50: Bylaws Appendix B.1: OPO Compliance
Page 51 and 52: Bylaws Appendix B.4: OPO PersonnelO
Page 55 and 56: Bylaws Appendix D.5: Transplant Pro
Page 57 and 58: Transplant hospitals must:Address e
Page 61 and 62: Bylaws Appendix D.10.A: Transplant
Page 63 and 64: Bylaws Appendix F.6.E: Conditional
Page 67 and 68: Bylaws Appendix K.4.A: Notice to th

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