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

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><div class = "justify" style = "text-align:left">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.</div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block">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.</div><div class = "text-block">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.</div><div class = "text-block"><span style = "font-weight:bold;">References (attached)</span></div><div class = "text-block"><ul style = "list-style-type:disc;"><li style = "counter-reset:ol0;list-style-type:disc;"><a href="https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">OPTN Policies Effective as of April 3 2020 [Emergency COVID-19 Policy Actions]</span></a><span style = "font-style:italic;">Organ Procurement and Transplantation Network</span><span>, 2020 Apr.</span></li><li style = "counter-reset:ol0;list-style-type:disc;"></li><li style = "counter-reset:ol0;list-style-type:disc;"><a href="file:///C:\Users\cswanson\Desktop\IIDP%20SOPs\protocols.io\QA-008%20Donor%20Criteria\a%20href=%22optn.transplant.hrsa.gov\...\2013_phs_guideline.pdf%22%20target=”_blank”" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">2013 PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission through Organ Transplantation1 Behavioral Risk Factors for Recent HIV, HBV, or HCV Infection</span></a><span>. </span><span style = "font-style:italic;">Organ Procurement and Transplantation Network</span><span>, 2013 Nov.</span></li></ul></div><div class = "text-block"><ul style = "list-style-type:disc;"></ul></div></div>

[STEPS]
?. [I.	IIDP Donor Inclusion Criteria]
The following are IIDP Inclusion Criteria for Pancreas Donors for Human Islet Isolation:
?. [I.	IIDP Donor Inclusion Criteria]
A multi-organ donor or pancreas-only donor if the donor meets all the criteria for multi-organ donation
?. [I.	IIDP Donor Inclusion Criteria]
Adequate in situ  hypothermic perfusion using UW or similar organ preservation solution for perfusion and cold storage
?. [I.	IIDP Donor Inclusion Criteria]
Maximum 18-hour cold ischemia
?. [I.	IIDP Donor Inclusion Criteria]
Donor age of 0 years to 65 years (no minimum age)
?. [I.	IIDP Donor Inclusion Criteria]
Duration of life support
?. [I.	IIDP Donor Inclusion Criteria]
Warm ischemia / Down time
?. [II.	General Donor Preclusions / Exclusions]
The following are frequently encountered disease states or other conditions which constitutes rejection of a potential donor:
?. [II.	General Donor Preclusions / Exclusions]
Clinical or active viral Hepatitis (A, B, or C)
?. [II.	General Donor Preclusions / Exclusions]
Acquired Immunodeficiency Syndrome (AIDS)
?. [II.	General Donor Preclusions / Exclusions]
HIV seropositivity (HIV-I or HIV-II)
?. [II.	General Donor Preclusions / Exclusions]
Syphilis
?. [II.	General Donor Preclusions / Exclusions]
Active viral encephalitis or encephalitis of unknown origin
?. [II.	General Donor Preclusions / Exclusions]
Creutzfeldt–Jacob Disease
?. [II.	General Donor Preclusions / Exclusions]
Rabies
?. [II.	General Donor Preclusions / Exclusions]
Recently treated (last 2 years) or active Tuberculosis
?. [II.	General Donor Preclusions / Exclusions]
Untreated septicemia
?. [II.	General Donor Preclusions / Exclusions]
Malignancies except primary brain tumors or non-melanoma of the skin
?. [II.	General Donor Preclusions / Exclusions]
Serious illness of unknown etiology as the cause of death
?. [II.	General Donor Preclusions / Exclusions]
EBV IgM positive
?. [II.	General Donor Preclusions / Exclusions]
CMV IgM positive
?. [II.	General Donor Preclusions / Exclusions]
COVID 19 (Sars-CoV-2 test) positive
?. [II.	General Donor Preclusions / Exclusions]
As of May 1, 2020 the IIDP is requiring negative testing for COVID-19 for all IIDP pancreas donors.
?. [II.	General Donor Preclusions / Exclusions]
The COVID-19 (SARS-CoV-2) test must be performed on the donor and have negative results.
?. [II.	General Donor Preclusions / Exclusions]
If negative results are obtained, the following additional information should be provided:a.  Specimen date and time
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							b.  Specimen type
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							c.  Upper Respiratory (e.g. (NP) nasopharyngeal swab, tracheal aspirate)
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							d.  Lower Respiratory (e.g. (BAL) bronchoalveolar lavage)
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							e.  Blood
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							f.   Other, please specify
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?. [II.	General Donor Preclusions / Exclusions]
For blood specimens, provide the test method used:    a.  Nucleic acid detection (e.g. real time RT-PCR)    b.  Serology (e.g. IgG/IgM/IgA antibody)    c.  Other, please specify
?. [II.	General Donor Preclusions / Exclusions]
The following are the "PHS 2013 Guidelines for Reducing the Transmission of HIV, Hep C and Hep B through Transplantation":
Transplant  surgeons and the IIDP Center Directors make decisions to transplant organs and/or process pancreata for islet isolation based on individual situations with regards to these guidelines.
?. [II.	General Donor Preclusions / Exclusions]
People who have had sex with a person known or suspected to have HIV, HBV, or HCV infection in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
Men who have had sex with men (MSM) in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
Women who have had sex with a man with a history of MSM behavior in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
People who have had sex in exchange for money or drugs in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
People who have had sex with a person who had sex in exchange for money or drugs in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
People who have had sex with a person who injected drugs by intravenous, intramuscular, or subcutaneous route for nonmedical reasons in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
A child who is 18 months of age and born to a mother known to be infected with, or at increased risk for, HIV, HBV, or HCV infection
?. [II.	General Donor Preclusions / Exclusions]
A child who has been breastfed within the preceding 12 months and the mother is known to be infected with, or at increased risk for, HIV infection
?. [II.	General Donor Preclusions / Exclusions]
People who have injected drugs by intravenous, intramuscular, or subcutaneous route for nonmedical reasons in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
People who have been in lockup, jail, prison, or a juvenile correctional facility for more than 72 consecutive hours in the preceding 12 months
?. [II.	General Donor Preclusions / Exclusions]
People who have been newly diagnosed with, or have been treated for, syphilis, gonorrhea, Chlamydia, or genital ulcers in the preceding 12 months
?. [III.  Donor Information]
A copy of the Donor Information Form, including Serology Test results, Medical and Social History, Consent Form, and OR Management Sheets must be received with the pancreas or by fax before processing may begin.
?. [III.  Donor Information]
A copy of the negative results of the COVID-19 (SARS-CoV-2) testing document must be uploaded to the IIDP website before broadcast.