TITLE: ADI IsletCore Minimal Donor Criteria
AUTHORS: Jocelyn E Manning Fox, James Lyon, Patrick MacDonald

[DESCRIPTION]
This SOP defines the pancreas donor profile acceptable for use by the Alberta Diabetes Institute IsletCore in their human islet isolation program. 

ADI IsletCore receives pancreases from multiple Canadian Organ Procurement Organizations (OPO). The OPO reports anonymized donor information and serology results to ADI IsletCore. Informed consent for research use of the pancreas is obtained and held on record by the relevant OPO. 


[GUIDELINES]
Responsibilities

This SOP applies to the Alberta Diabetes Institute IsletCore.

It is the responsibility of ADI IsletCore staff to both follow and ensure adherence to the donor criteria outlined in this SOP prior to acceptance of a pancreas

It is the responsibility of the ADI IsletCore staff to ensure that information relating to the donor is provided by the Organ Procurement Organization (OPO), and that this is accurately recorded in IsletCore’s database, and the accompanying paperwork is filed securely. 



Abbreviations

ADI: Alberta Diabetes Institute

SOP: Standard Operating Procedures

NDD: neurological determination of death.

DCD: Donation after cardiocirculatory death.

MAID: Medical assistance in dying.

HbA1c: Hemoglobin A1c.

CPR: Cardiopulmonary resuscitation.

HIV: Human immunodeficiency virus

HTLV: Human T-lymphotropic virus

HBsAg: Hepatitis B surface antigen

Anti-HBc: Hepatitis B core antigen

Anti-HCV: Anti Hepatitis C antibodies

NAT HIV: Nucleic acid test human immunodeficiency virus

NAT Hep C: Nucleic acid test hepatitis C

SARS CoV-2: Virus causing COVID-19


Acknowledgments: 

We thank the Organ Procurement Organizations, including Human Organ Procurement and Exchange (HOPE) program and Trillium Gift of Life Network (TGLN), for their work in procuring human donor pancreas for research. We especially thank the organ donors and their families for their kind gift in support of diabetes research.

[STEPS]
SECTION: ADI IsletCore Donor Inclusion Criteria
1. The following are ADI IsletCore inclusion criteria for pancreas donors for human islet isolation:

A multi-organ donor or pancreas-only donor if the donor meets all the criteria for multi-organ donation
Any type of donation (NDD, DCD, MAID)
DCD warm ischemia time <30 minutes
Adequate in situ hypothermic perfusion using UW or similar organ preservation solution for perfusion and cold storage
Maximum 24 hour cold ischemia
Donor age of 0 years to 100 years (no minimum age)
Any donor body mass index (BMI)
Any donor HbA1c
Any donor diabetes status (no diabetes, Type 1 diabetes, Type 2 diabetes, other types of diabetes)
Peak amylase between 40 to 140 units per litre (no data also acceptable)
Peak lipase between 0 to 160 units per litre
Duration of life support < 14 days
Warm ischemia / Down time < 60 minutes (including CPR)
SECTION: General Donor Preclusions / Exclusions
2. The following represent disease states or other conditions that are criteria for rejection of a potential donor. 

Recently treated (last 2 years) or active tuberculosis
Serious illness of unknown etiology as the cause of death
Active viral encephalitis or encephalitis of unknown origin
Creutzfeldt–Jacob Disease
Rabies
Positive test result for any of the following:
Anti-HIV 1 & 2 
Anti-HTLV 1 & 2
HBsAg
Anti-HBc
Anti-HCV
Syphilis
NAT HIV
NAT Hep C
Blood culture
SARS CoV-2 (evidence of previous positive testing >30 days prior, with negative testing at time of donation, is acceptable)
SECTION: Additional Criteria
3. Additional exclusion criteria may be applied by procurement surgeons and/or IsletCore staff on a case-by-case basis, following review of donor’s social and medical history, and physical assessment of the pancreas.