1. Donation Process: Honoring the Gift Breakout Session B Presenters: Scott Snider, RN, Multi-Organ Transplant Coordinator, St. Vincent Medical Center Scott Bunting, RRT, CPTC, OneLegacy Moderator: Ervin Ruzics, MD, Saint Joseph Hospital

2. Identify the various entities that support the donation process Review the three phases of donor management and the corresponding timeframes Review the criteria that is utilized for patients to be placed on the waitlist Discuss the factors involved for transplant candidate evaluation Objectives:

3. How can I utilize this information on donor management and transplant candidate criteria to improve donation practice in my hospital? Questions to Run On:

4. Recipient Workup From Authorization to Allograft

5. Questions to Run On  Describe the criteria that is utilized for patients to be placed on the waitlist.  Identify the factors involved for transplant candidate evaluation. What are the considerations for living donors?

6. Kidney Disease Outcome Quality Initiative ( K/DOQI) Staging  K/DOQI created the standardization of clinical practice guidelines.  Two primary markers are used to stage Chronic Kidney Disease (CKD). Abnormalities in serum and urine lab tests:  BUN, Creatinine  Level of Kidney function as measured by Glomerular Filtration Rate (GFR).

7. Who Are Our Patients?  Stages of Kidney Failure- K/DOQI Staging: StageDescriptionGFR (ml/min) 1 Kidney damage with normal or increased GFR Equal to, or > 90 2 Kidney damage with mild decrease in GFR60-90 3 Moderate decrease in GFR30-59 4 Severe decrease in GFR15-29 5 Kidney failureLess than 15

8. Who can be listed?  A patient must be in stage 4 or 5 End Stage Renal Disease (ESRD)  Renal failure must be chronic and irreversible  GFR must be <20 to accrue wait time  A live renal transplant may be completed prior to the initiation of dialysis and GFR does not need to be <20.

9. Kidney Pancreas Transplant  The goal of kidney pancreas transplant is to cease the need for insulin dosage and to ease the suffering of sequelae of diabetes such as:  Gastroparesis  Renal Failure  Retinopathy  Neuropathy  Accelerated Cardiovascular disease  Improves quality of life  Patients receive a kidney/pancreas transplant as Type 1 diabetes has caused irreversible damage to both pancreas and kidney

10. Candidate Evaluation  Physiologically the potential candidate needs to be able to withstand the transplant procedure itself and have a lower risk of long term morbidity and mortality.  If the potential candidate is able to resolve contraindications found at initial assessment, then they may be re-assessed.  Older age, in itself, is not a contraindication.

11. Pre-Transplant Workup  Physical Exam  Medical/Surgical History  Chest X-ray  Ultrasound  Blood Tests  Blood Typing  Tissue Typing (HLA)  Viral Testing  Pap/Mammogram  Echocardiogram  Cardiac Stress Test  Dental Evaluation  Psychosocial Evaluation  Dietary Evaluation

12. Multi-Disciplinary Team  Transplant Surgeon  Transplant Nephrologist  Transplant Coordinator  Transplant Pharmacist  Transplant Social Worker  Cardiologist  Floor Nurse  Transplant Registered Dietitian  Financial Counselor  Office Staff

13. Pre-Transplant Lab Tests  CBC  PT/PTT, inr  CMP  LFT’s  U/A, urine Cx, UPC ratio (If not anuric)  Serologies  HBsAb, HBsAg, HBcAb, HIV, HCV pcr, CMV, EBV, HSV, VZV  PSA (males over 50)  PPD  HgB A1c  Pregnancy eval if appropriate  ABO x 2  HLA tissue typing and identification of potential DSA’s  Panel of Reactive Antibodies (PRA)

14. Pre-Transplant Waitlist & Evaluation Process Potential recipient meets with Multi–Disciplinary Team Potential recipient receives education regarding the risks and benefits of transplant, medical and financial acceptability, tests that will be required, and the organ allocation process. Potential recipient completes work up and lab tests. Patient Selection Committee. All candidates added to the transplant waitlist must be approved through the Patient Selection Committee. Testing for any potential living donor will be done after the patient waiting for an organ is placed on the active transplant waitlist. When a patient is on the active waitlist, he/she must follow up with transplant team bi-annually until the transplant has occurred.

15. Absolute Contraindications To Transplantation  Severe, untreatable heart or lung disease  Active or uncontrollable cancer  Current alcohol abuse or drug addiction  Uncontrollable infection  Uncontrollable HIV infection  Failure of other organs that will not improve with transplant.  Limited life expectancy  History of non-compliance medical/dietary recommendations pre-transplant

16. Living Donation – Informed Consent Education is imperative to enable the potential living donor to understand all aspects of the donation process, especially the risks and benefits. The goal of informed consent is to ensure that a potential donor understands:  That he or she will undertake risk and will receive no financial benefit from the donor nephrectomy  That he or she may be at risk for psycho/social issues: depression or anxiety related to complication from surgery, feelings of burden, body image, family tensions, loss of employment and related financial or emotional concern.  That there are general risks of the operation.

17. Living Donor Testing  H & P  Labs: CBC, CMP, LFT’s, Serologies, HLA tissue typing, Cross match, Lipid panel, U/A, Urine culture, UPC ratio, pregnancy evaluation, ABO, and any other lab tests that may be indicated.  Nephrology/Urologic evaluation  CXR  ECG  Cardiac stress test for donors >50 years  MRI, angiography, 3D CT, CT angiogram/Urogram  Psychosocial evaluation

18. Transplant procedure  The patient is anesthetized and a central venous catheter and urinary catheter are placed.  The bladder is decontaminated with antibiotic solution  The usual placement of the kidney is extraperitoneal in the iliac fossa.  Pancreas will also be placed extraperitoneally  Vascular anastamosis will be to iliac artery and vein. The kidney should turn pink and produce urine immediately.  Pancreas head will either be anastomosed to small bowel (enteric drained)or to bladder (bladder drained)  Approximated 2 liters of pancreatic fluid will be reabsorbed if enteric drained. If bladder drained, these pancreatic fluids will be excreted and may cause fluid depletion.  The donor ureter is anastomosed to the recipient bladder and a double J stent is placed. This stent facilitates healing across the anastamosis and will be removed in the transplant clinic in 4-6 weeks via cystoscopy  After organ(s) are placed a final check for hemostasis and the positioning of the vessels is done and a standard wound closure is done.

19. Immunosuppressive Therapy All patients who receive a transplant are placed on a medication regime that suppresses the bodies’ natural immune response to protect the integrity of the graft. There are many possible combinations of medication regimes, depending on the center’s protocol.  Induction Therapy  Initial potent prophylactic immunosuppression at the time of transplant to prevent hyper-acute or acute rejection  Agent of choice is dependent on recipients pre-existing medical conditions, donor characteristics, and the maintenance immunosuppressive regimen to be used  Lymphocyte count will drastically decrease.  Anti-fungal, anti-viral and anti-bacterial prophylaxis is required  Effect may last for months  Maintenance Immunosuppression  Medications will be taken for the life of the allograft  Patient compliance is critical to graft survival  Goal is to prevent rejection

20. Renal Transplant

21. Enteric Drainage (Panreaticojejunostomy)  Anastamosis of pancreas to Jejunum via a Roux-en-Y loop  Mimics normal enteric drainage of pancreatic enzymes  Difficult to diagnose rejection, can't measure secretion of enzymes

22.  Pancreas anastomosed to the recipients bladder  Offers a direct method for assessing graft exocrine function (urine amylase decreases earlier than changes in blood glucose if graft is rejecting)  Complications:  Metabolic acidosis from bicarbonate loss into urine  Ulceration/bleeding at duodenal segment  Cystitis  Volume imbalance due to excretion of ~ 2000 ml pancreatic fluid daily. Urinary Diversion (Pancreaticoduodencystostomy)

23. Authorization to Procurement Scott Bunting, RRT, CPTC Procurement Transplant Coordinator

24. 4 Primary responsibilities/duties Hospital Development- DDC, PTC Donor Management – PTC, MD, RN Organ Allocation – PTC, DAC Family Support – FCS, PTC

25. Umbrella Organizations United Network for Organ Sharing Maintains the National Organ Transplant Waiting List under contract with the U.S. Department of Health and Human Services American Association of Tissue Banks Provides tissue banking standards to promote quality and safety in tissue transplantation Association of Organ Procurement Organizations Recognized as the national representative of organ procurement organizations (OPOs) The EBAA is the nationally recognized accrediting body for eye banks

26. Maintains U.S. organ transplant waiting list Determines national organ donation policy Private, non-profit organization that operates the Organ Procurement & Transplantation Network & U.S. Scientific Registry of Transplant Recipients Under contract with Centers for Medicare & Medicaid Services (CMS) of the U.S. Dept. of HHS United Network for Organ Sharing (UNOS)

27. Hospital Development Policy & Procedure  State Law  Regulations  Hospital Policy Staff education - DDC, PTC  Real time  Inservices Medical Record review– DDC Policy & Procedure  State Law  Regulations  Hospital Policy Staff education - DDC, PTC  Real time  Inservices Medical Record review– DDC

28. Maintain SBP > 100 (MAP > 60)  Maintain euvolemia  Vasopressor support Maintain Urine Output > 0.5/mL/kg/hr  Treat DI with vasopressin or DDAVP Maintain PO2 > 100 and pH 7.35-7.45 Monitor and treat electrolytes Monitor and treat blood glucose Monitor and treat anemia, coagulopathy, and thrombocytopenia Maintain temp 36.5-37.5  C Pre-Donor Management Recommendations

29. 3 Phases of Donor Management Resuscitation Phase  First 6 – 12 hrs Plateau Phase  12 – 24 hrs Recovery Phase  Next 24 – 36 hrs

30. Resuscitation Phase 6 - 12 hrs  Lab testing, Radiology  A-Line, Central line  Fluids- Colloids-Hespan, Blood  Free Water Gavage  Hormone Replacement Vasopressin, Solumedrol, T4  Reduction of vasopressors Add Dobutamine 0.5 mg Serologic & HLA testing Coroner Release Resuscitation Phase

31. Organ specific testing  Bronchoscopy, CT  Echo, Angio,  Abd Ult Organ Allocation  Kidney & Pancreas Lists Crossmatch Plateau Phase

32. PTC uploads chart to UNOS - Donornet  Confirm Height, Weight, DCD vs BD  ABO, HLA, Serologies  Labs, CXR, EKG, Echo, Angio UNOS Regulations –Minimum requirement for organ offers Timeout prior to generating match runs  Timeout between field coordinator (PTC) and off-site coordinator (DAC)  Reduction of errors Organ Allocation UNOS – United Network for Organ sharing Donornet – Web based system maintained by UNOS for organ offers

33. Kidney Placement (cont’d) Who gets choice of kidney?  Direct donation  Life saving organ (heart kidney, liver kidney) What do you do if you have both? Who accepted the organ first  Pancreas  0mm  Local High PRA  Pediatrics  Payback  Local list

34. Liver Placement Minimum information for Liver Offer  UNOS Policy 3.6.9 When do you re-run the liver list?  Splitting the liver from a pediatric donor Which livers can we split?  Less than 40 years of age  On a single vasopressor or less  Transaminases no greater than 3 times normal  BMI of 28 or less Share 35

35. Heart/Lung Placement Optimize thoracic organs prior to testing  ECHO, bronch, angios  Repeat tests as required

36. Donor Management  fluid shifting- encourage diuresis Albumin, Lasix Recovery Phase  Organ Allocation of heart Lungs completed  OR set Recovery Phase

37. Family Support – FCS, PTC Assess Family needs  Out of town  Children Directed Donation requests Provide Coroner information Funeral Home Time Frames / updates

38. Web Resources OneLegacy www.onelegacy.org www.onelegacy.org United Network for Organ Sharing www.unos.org www.unos.org Organ Procurement and Transplantation Network www.optn.transplant.hrsa.gov www.optn.transplant.hrsa.gov Donate Life California Registry www.donateLIFEcalifornia.org www.donateLIFEcalifornia.org

39. How can I utilize this information on donor management and transplant candidate criteria to improve donation practice in my hospital? Questions to Run On: