TITLE: Determining IIDP Minimal Donor Criteria 
AUTHORS: Integrated Islet Distribution Program

[DESCRIPTION]
This SOP defines the pancreas donor profile acceptable for use in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored research in the Integrated Islet Distribution Program (IIDP).  This SOP applies to all IIDP islet distribution centers using funds from the NIDDK to manufacture purified human pancreatic islets for basic research studies for IIDP approved investigators.

 

The IIDP depends on the subcontracted human islet isolation centers to provide research investigators with human islets. It is the responsiblity of the human islet centers to obtain research quality pancreata from the Organ Procurement Organizations (OPO).  Some criteria are stricter than those used by transplant centers for organ transplant donors.  This protocol provides the inclusion and exclusion criteria in order to determine the proper parameters for research donors.

The donor criteria also reflects the required 2020 testing for COVID-19.   Positive testing for COVID-19, HIV, Hepatitis C, and Hepatitis B are examples of some exclusion criteria.


References (attached)

Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection — U.S. Public Health Service Guideline, 2020   (Click on hyperlink pop-up)

  Policies - OPTN (hrsa.gov); Policy 2, 5, 11 (Click on hyperlink pop-up or pdf)


[GUIDELINES]
OPO Organ Acceptance Criteria

Each organ procurement organization (OPO) must establish criteria for an acceptable deceased donor or deceased donor organ for the transplant programs in its Donation Service Area (DSA).  More information is included in the attached  OPTN Policy last updated 3/16/23.   

Center Responsibilities

This SOP applies to all IIDP islet distribution centers using funds from the NIDDK to manufacture purified human pancreatic islets for basic research studies for IIDP approved investigators.

It is the responsibility of the IIDP Islet Isolation Center to both follow and ensure adherence to the donor criteria outlined in this SOP prior to acceptance of pancreata.

It is the responsibility of the IIDP Islet Isolation Center to verify that the donor criteria provided by the Organ Procurement Center (OPO) on the paperwork accompanying the pancreata is accurate before the isolation.

Definitions

Integrated Islet Distribution Program (IIDP) (RRID:SCR_014387):  The IIDP is a contracted program commissioned and funded by the NIDDK to provide quality human islets to the diabetes research community to advance scientific discoveries and translational medicine. The IIDP consists of the NIDDK, the Project Officer (PO), the External Evaluation Committee (EEC) and the CC at City of Hope (COH). The IIDP CC integrates an interactive group of academic laboratories including the subcontracted IIDP centers.

IIDP Coordinating Center (CC):Joyce Niland, Ph.D. is the Principal Investigator for the IIDP CC and leads staff from the Department of Research Information Sciences at COH to coordinate the activities of the IIDP and assist the participating centers and investigators in the distribution of human islets.

Organ Procurement Organizations (OPO): Organ Procurement Organizations (OPOs) are not-for-profit organizations responsible for recovering organs from deceased donors for transplantation in the U.S. There are 58 OPOs, each mandated by federal law to perform this life-saving mission in their assigned donation service area.

[STEPS]
SECTION: I.	IIDP Donor Inclusion Criteria
1. The following are IIDP Inclusion Criteria for Pancreas Donors for Human Islet Isolation:
SECTION: I.	IIDP Donor Inclusion Criteria
1.1. A multi-organ donor or pancreas-only donor if the donor meets all the criteria for multi-organ donation
SECTION: I.	IIDP Donor Inclusion Criteria
1.2. Adequate in situ  hypothermic perfusion using UW or similar organ preservation solution for perfusion and cold storage
SECTION: I.	IIDP Donor Inclusion Criteria
1.3. Maximum 18-hour cold ischemia
SECTION: I.	IIDP Donor Inclusion Criteria
1.4. Donor age of 0 years to 75 years (no minimum age)
SECTION: I.	IIDP Donor Inclusion Criteria
1.5. Duration of life support < 14 days
SECTION: I.	IIDP Donor Inclusion Criteria
1.6. Warm ischemia / Down time < 60 minutes (including cardiac arrests)
SECTION: II.	General Donor Preclusions / Exclusions
2. The following are frequently encountered disease states or other conditions which constitutes rejection of a potential donor:


SECTION: II.	General Donor Preclusions / Exclusions
2.1. Clinical or active viral Hepatitis (A, B, or C)
SECTION: II.	General Donor Preclusions / Exclusions
2.2. Acquired Immunodeficiency Syndrome (AIDS)
SECTION: II.	General Donor Preclusions / Exclusions
2.3. HIV seropositivity (HIV-I or HIV-II)
SECTION: II.	General Donor Preclusions / Exclusions
2.4. Syphilis
SECTION: II.	General Donor Preclusions / Exclusions
2.5. Active viral encephalitis or encephalitis of unknown origin
SECTION: II.	General Donor Preclusions / Exclusions
2.6. Creutzfeldt–Jacob Disease
SECTION: II.	General Donor Preclusions / Exclusions
2.7. Rabies
SECTION: II.	General Donor Preclusions / Exclusions
2.8. Recently treated (last 2 years) or active Tuberculosis
SECTION: II.	General Donor Preclusions / Exclusions
2.9. Untreated septicemia
SECTION: II.	General Donor Preclusions / Exclusions
2.10. Malignancies except primary brain tumors or non-melanoma of the skin
SECTION: II.	General Donor Preclusions / Exclusions
2.11. Serious illness of unknown etiology as the cause of death
SECTION: II.	General Donor Preclusions / Exclusions
2.12. EBV IgM positive
SECTION: II.	General Donor Preclusions / Exclusions
2.13. CMV IgM positive
SECTION: II.	General Donor Preclusions / Exclusions
2.15. COVID 19 (Sars-CoV-2 test) positive active infection at time of donation (As of May 1, 2020 the IIDP is requiring negative testing for COVID-19 for all IIDP pancreas donors)

Evidence of previous positive donor COVID-19 testing >28 days, prior to negative testing at time of donation, is acceptable
 
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3. The following are the revised recommendations: 

Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection — U.S. Public Health Service (PHS) Guideline, 2020

 



SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.1. People who have had sex with a person known or suspected to have HIV, HBV, or HCV infection in the preceding 3 months
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.2. Men who have had sex with men (MSM) in the preceding 3 months
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.3. A person with unknown medical or social history
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.4. People who have had sex in exchange for money or drugs in the preceding 3 months
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.5. People who have had sex with a person who had sex in exchange for money or drugs in the preceding 3 months
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.6. People who injected drugs for non medical reasons.   

SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.7. People who have had sex with a person who injected drugs by intravenous, intramuscular, or subcutaneous route for nonmedical reasons in the preceding 3 months
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.8. A child born to a mother with HIV, HBV, or HCV infection
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.9. A child breastfed by a mother is known to be infected with HIV infection
SECTION: III. Public Health Services Guidelines  Assessing Solid Organ Donors
3.10. People who have been incarcerated (confinement in jail, prison, or a juvenile correctional facility) for >72 consecutive hours in the preceding 3 months
SECTION: IV.   Minimum IIDP Donor Criteria List
4. Attached is a condensed list of the Donor Criteria. 
  

SECTION: V.  Donor Information Forms
5. A copy of the Donor Information Form, including Serology Test results, Medical and Social History, Consent Form, and OR Management Sheets should be received, with the pancreas or by fax, before the Center's start processing however this information does not need to be provided to IIDP
SECTION: II.	General Donor Preclusions / Exclusions
2.14. Toxoplasma Immunoglobulin G (IgG) positive
SECTION: I.	IIDP Donor Inclusion Criteria
1.7. Body Mass Index (BMI) of 10-50 kg/m2