3 Reasons Did Not Donate Form

OMB Control No. 0906-0034

Expiration Date XX/XX/XXXX

Reasons Did not Donate Form (Liver or Kidney)

Public Burden Statement: The purpose of this data collection is to track long-term health outcomes for living organ donors. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0906-0034, and it is valid until XX/XX/XXXX. This information collection is voluntary. Data will be kept private to the extent allowed by law. Information proposed to be collected is considered to be protected health information. SRTR is a public health authority under the HIPAA Privacy Rule (45 CFR 164.512(b)). Also refer to the HRSA System of Record Notice 09–15–0055, https://www.federalregister.gov/documents/2022/08/01/2022-16344/privacy-act-of-1974-system-of-records. Public reporting burden for this collection of information is estimated to average .29 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N39, Rockville, Maryland, 20857, or paperwork@hrsa.gov.

Donation Decision Overview

1. Did the Candidate donate an organ?

   • Yes

   • No

1a. If Yes, date of donation:

1b. If Yes, please list the OPTN 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:

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

• Concern for future pregnancy and childbirth

• Possible current or future malignancy or cancer

• Liver disease

• Lung disease including sarcoidosis, cysts, nodules, pulmonary hypertension

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

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

• Vascular or biliary anatomic abnormalities on imaging

• Inadequate liver volumes on imaging

• Other unfavorable anatomical abnormality on imaging

• Donor liver steatosis on imaging or biopsy

• Other biopsy abnormalities

• Diabetes, high A1C or high blood glucose

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

• Obesity

• Hypertension, blood pressure control or borderline high blood pressure

• High cholesterol, high triglycerides or other lipid abnormalities

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

• Risk of transmitting an infection to the intended recipient

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

• History of chronic pain from headaches, musculoskeletal problems or surgery

• Another living donor candidate was a better HLA match

• Another living donor candidate was a better choice for medical reasons

Psychosocial:

• Psychiatric illness

• Multiple psychosocial stressors

• Candidate felt coerced

• Member(s) of family against the candidate donating

• Lack of health insurance coverage

• Economic burden or difficulty taking time off work

• Another living donor candidate was a better choice for psychosocial reasons

Other:

• Another living donor candidate was a better choice for other reasons

• Intended recipient underwent deceased donor transplant

• Intended recipient decided not to undergo transplant

• Intended recipient decided not to have this candidate donate

• Intended recipient became too ill for transplant or died

• Intended recipient liver function improved

• Intended recipient did not use the candidate for other reasons

• Candidate decided risk was too high

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

• Decided against donation for undisclosed reason(s)

• 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:

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

• Concern for future pregnancy and childbirth

• Possible current or future malignancy or cancer

• Liver disease

• Lung disease including sarcoidosis, cysts, nodules, pulmonary hypertension

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

• Diabetes, high A1C or high blood glucose

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

• Obesity

• Hypertension, blood pressure control or borderline high blood pressure

• High cholesterol, high triglycerides or other lipid abnormalities

• Hematuria

• Proteinuria, albuminuria or microscopic albuminuria

• Abnormal kidney biopsy

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

• Kidney cysts

• Risk of kidney stones

• Renal artery fibromuscular dysplasia

• Other renal artery disease such as atherosclerotic disease or aneurysm

• Multiple renal arteries or veins

• Anatomical abnormality such as scarring, small kidneys or hydronephrosis

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

• Risk of transmitting an infection to the intended recipient

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

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

• History of chronic pain from headaches, musculoskeletal problems or surgery

• Another living donor candidate was a better HLA match

• Another living donor candidate a better choice for medical reasons

Psychosocial:

• Psychiatric illness

• Multiple psychosocial stressors

• Candidate felt coerced

• Member(s) of family against the candidate donating

• Lack of health insurance coverage

• Economic burden or difficulty taking time off work

• Another living donor candidate was a better choice for psychosocial reasons

Other:

• Another living donor candidate was a better choice for other reasons

• Intended recipient underwent deceased donor transplant

• Intended recipient decided not to undergo transplant

• Intended recipient decided not to have this candidate donate

• Intended recipient became too ill for transplant or died

• Intended recipient kidney function improved

• Intended recipient did not use the candidate for other reasons

• Decided against donation for undisclosed reason(s)

• Candidate decided risk was too high

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

• Other, K2a. Specify:

OMB Number 0906-0034 (Expires XX/XX/XXXX)