Amendment 0001 Questions Answers SRTR - Attachment 1.pdf

OMB Number 0906-0034 (Expires 01/31/2021)

Living Donor Collective Donation Decision Worksheet (Kidney and Liver)

Donation Decision Overview

1. Did the Candidate donate an organ?

o Yes o No

1a. If Yes, date of donation: ______________ 1b. If Yes, please list the UNOS Donor ID: __________ 1c. If No, date of decision not to donate: ___________

Liver-Specific: Reasons Candidate Did Not Donate

L1. At the time a decision was made, the evaluation of the donor candidate (check best answer):

□ Was complete

□ Was complete except for MRI

□ Lacked MRI and a few components of the evaluation

□ Lacked MRI and many components of the evaluation

L2. Indicate reason(s) the candidate did not donate (check all that apply). Except where indicated, all reasons on this list apply to the donor candidate and not to the intended recipient.

Please check all that apply in any of the following three categories:

Categories: (check all that apply):

Medical:

1. Unable to provide informed consent due to cognitive impairment, a developmental disability or being too young

2. Concern for future pregnancy and childbirth

3. Possible current or future malignancy or cancer

4. Liver disease

5. Lung disease including sarcoidosis, cysts, nodules, pulmonary hypertension

6. Cardiovascular disease such as coronary artery disease, abnormal cardiac stress test, stroke, transient ischemic attack, abnormal carotid ultrasound or claudication

7. Increased risk of bleeding or clotting, including low or high platelet counts or anemia

8. Vascular or biliary anatomic abnormalities on imaging

9. Inadequate liver volumes on imaging

10. Other unfavorable anatomical abnormality on imaging

11. Donor liver steatosis on imaging or biopsy

12. Other biopsy abnormalities

13. Diabetes, high A1C or high blood glucose

14. Concern for risk of developing diabetes, borderline blood glucose or features of metabolic syndrome

15. Obesity

16. Hypertension, blood pressure control or borderline high blood pressure

17. High cholesterol, high triglycerides or other lipid abnormalities

18. Immunologic incompatibility with the intended recipient including blood group incompatibility or HLA antibodies

19. Risk of transmitting an infection to the intended recipient

20. Substance abuse including alcohol, tobacco, marijuana or narcotics.

21. History of chronic pain from headaches, musculoskeletal problems or surgery

22. Another living donor candidate was a better HLA match

23. Another living donor candidate was a better choice for medical reasons

Psychosocial:

24. Psychiatric illness

25. Multiple psychosocial stressors

26. Candidate felt coerced

27. Member(s) of family against the candidate donating

28. Lack of health insurance coverage

29. Economic burden or difficulty taking time off work

30. Another living donor candidate was a better choice for psychosocial reasons

Other:

31. Another living donor candidate was a better choice for other reasons

32. Intended recipient underwent deceased donor transplant

33. Intended recipient decided not to undergo transplant

34. Intended recipient decided not to have this candidate donate

35. Intended recipient became too ill for transplant or died

36. Intended recipient liver function improved

37. Intended recipient did not use the candidate for other reasons

38. Candidate decided risk was too high

39. Candidate reluctant or ambivalent as indicated by missed appointments failure to return calls, etc.

40. Decided against donation for undisclosed reason(s)

41. Other, L2a. Specify: _______________________________________

Kidney-Specific: Reasons Candidate Did Not Donate K1. At the time a decision was made, the evaluation of the donor candidate (check best answer):

□ Was complete

□ Was complete except for imaging study

□ Lacked imaging study and a few components of the evaluation

□ Lacked imaging study and many components of the evaluation

K2. Indicate reason(s) the candidate did not donate (check all that apply). Except where indicated all reasons on this list apply to the donor candidate and not to the intended recipient. Please check any and all that apply in any of the following three categories:

Categories: (check all that apply):

Medical:

1. Unable to provide informed consent due to cognitive impairment, a developmental disability or being too young

2. Concern for future pregnancy and childbirth

3. Possible current or future malignancy or cancer

4. Liver disease

5. Lung disease including sarcoidosis, cysts, nodules, pulmonary hypertension

6. Cardiovascular disease such as coronary artery disease, abnormal cardiac stress test, stroke, transient ischemic attack, abnormal carotid ultrasound or claudication

7. Diabetes, high A1C or high blood glucose

8. Concern for risk of developing diabetes, including borderline blood glucose or features of metabolic syndrome

9. Obesity

10. Hypertension, blood pressure control or borderline high blood pressure

11. High cholesterol, high triglycerides or other lipid abnormalities

12. Hematuria

13. Proteinuria, albuminuria or microscopic albuminuria

14. Abnormal kidney biopsy

15. Low or borderline kidney function, GFR or creatinine clearance.

16. Kidney cysts

17. Risk of kidney stones

18. Renal artery fibromuscular dysplasia

19. Other renal artery disease such as atherosclerotic disease or aneurysm

20. Multiple renal arteries or veins

21. Anatomical abnormality such as scarring, small kidneys or hydronephrosis

22. Immunologic incompatibility with the intended recipient including blood group incompatibility or HLA antibodies

23. Risk of transmitting an infection to the intended recipient

24. Substance abuse including alcohol, tobacco, marijuana or narcotics.

25. Increased risk of bleeding or clotting, including low or high platelet counts or anemia

26. History of chronic pain from headaches, musculoskeletal problems or surgery

27. Another living donor candidate was a better HLA match

28. Another living donor candidate a better choice for medical reasons

Psychosocial:

29. Psychiatric illness

30. Multiple psychosocial stressors

31. Candidate felt coerced

32. Member(s) of family against the candidate donating

33. Lack of health insurance coverage

34. Economic burden or difficulty taking time off work

35. Another living donor candidate was a better choice for psychosocial reasons

Other:

36. Another living donor candidate was a better choice for other reasons

37. Intended recipient underwent deceased donor transplant

38. Intended recipient decided not to undergo transplant

39. Intended recipient decided not to have this candidate donate

40. Intended recipient became too ill for transplant or died

41. Intended recipient kidney function improved

42. Intended recipient did not use the candidate for other reasons

43. Decided against donation for undisclosed reason(s)

44. Candidate decided risk was too high

45. Candidate reluctant or ambivalent as indicated by missed appointments, failure to return calls, etc.

46. Other, K2a. Specify: _______________________________________

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