TITLE: 608.1 Donor Acceptance Criteria for URMC HTC SARS-CoV-2 / COVID-19 Cases
AUTHORS: Gloria S Pryhuber

[DESCRIPTION]
Purpose and Scope of the Procedure
Standardize process for receiving lung donations for COVID-19 studies
Scope: Coordination of screening, acceptance and receipt of tissue for research program

Principles 
Lung  donations rejected for transplantation can be used to understand human lung structure and development, ultimately to improve care of patients with lung disease
Rapid, standardized and safe processing of SARS-CoV2 infected human tissue requires coordination of a team of staff, materials and attention to protocols
See BSL2+ Safety Protocol (616.1, 617.1 URMC HTC BSL2+ Lung Tissue Protocols)
Rapid processing is required to maintain the tissues in a state as close to state at death as possible

[GUIDELINES]
Safety and Regulatory Considerations: 
Needs and Privacy of donating family should be respected at all times
Consent for tissue donation for research should be freely given
Proper consent process will be assured. 
Organs and biospecimens should be shipped safely and expeditiously
Shipping will meet the minimum requirement for dangerous goods under 49 CFR 172.700 and IATA 1.5. 

[STEPS]
SECTION: Review Case: accept or decline based on eligibility
1. Take referral call or BRINDL screening report
SECTION: Review Case: accept or decline based on eligibility
2. Review Eligibility Criteria
SECTION: Review Case: accept or decline based on eligibility
1.1. Start Case Record in BRINDL Inventory Screening Log
SECTION: Review Case: accept or decline based on eligibility
2.1. Inclusion Criteria
1.Gestational age >/= 22 0/7 weeks and live born
2.Age < 99 completed years of age 
3.Known time of death 
        3.1.Priority to donors after declaration of brain death by clinical care team, if appropriate, and planned recovery with minimal WIT
        3.2.Death in hospital (ex. delivery room, NICU, PICU, Emergency or Operating Room) 
        3.3.Known time of death prior to arrival in referral hospital
        3.4.Warm Ischemia Time (WIT) prior to organ cooling as short as possible;
            may accept up to 6 hours, max of 12 hours in unusual circumstance
4.Sample is to be lung unable to place for transplantation, biopsy of lung to be used for transplant or explanted diseased lung at transplant.
    5.Bystander normal tissue from lung resection, less preferred
    6. Disease/Exposure: Type II diabetes, current smoker, hypertension noted and accepted with limitations
    7. Evidence of acute respriatory failure (PaO2/FiO2 </= 300) due to pneumonia/ARDS or other cause acceptable if associated with COVID-19 disease or appropriate comparative non-COVID-19 disease
    8. Correctly completed consent by donor, or authorization by next of kin, for donation for research
SECTION: Review Case: accept or decline based on eligibility
2.2. Exclusion criteria
1.Warm Ischemia Time Unknown or > 12 hours 
2.Infection with high-level organism (Category A) representing risk for processing and shipment.
3.Disease/Exposure exclusions: cystic fibrosis, heavy tobacco or alcohol abuse
4.Evidence of significant lung trauma
SECTION: Review Case: accept or decline based on eligibility
2.3. Priority acceptance
1.Known lung disease – primary or secondary lung disease due to SARS-CoV-2
2.Normal lungs for comparison to SARS-CoV-2 infections
3.Secondary disease following documented SARS-CoV-2 infection with potential attribution to that infection, such as unexpected pulmonary or brain thrombosis.  History and evaluation for diagnoses must be available.
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
3. Organ Procurement Organization Recovery Team prepares for organ recovery as consistent with organ transplant protocol with cross clamp and in situ cold flush body cooling with minimal warm ischemic time.

Includes flush with UW/SPS-1, HTK or similar organ transplant buffer, until solution runs clear
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
4. Recover 1-2 Whole Lung(s) en bloc with at least the lower 1/3 of the trachea.
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
5. Complete a minimum back-table lung flush with transplant buffer of 500ml into the pulmonary artery and 500ml into the pulmonary vein. 

Do not flush with saline.
Do not wrap in surgical towel.
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
6. Staple, clamp, or tie the trachea closed prior to shipping. 
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
7. Place Lung(s) in a Specimen Bag and submerge with chilled UW/SPS-1 or HTK. Triple bag the tissue.
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
8. If available, recover the Whole Thymus. 

Place in a conical tube/specimen cup filled with chilled UW/SPS-1 or HTK.
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
9. If available, recover at least 3 cm x 3 cm x 3 cm of Spleen. 

Place in a Specimen Bag or a Rigid Container filled with chilled UW/SPS-1 or HTK.
SECTION: Requested processing protocol for Donation following Brain Death Declaration (DBD)
10. If available, recover a 10 CC sample of Blood in a Blood Tube - Green Top (Heparin). 

Immediately following recovery, invert the tube several times to mix with the anticoagulant.
SECTION: Requested processing protocol for Donation following Cardiac Death /Arrest(DCD)
11. Organ Procurement Organization / Recovery Team prepares for organ recovery as quickly following Cardiac Arrest while in comfort care as authorized by next of kin.

SECTION: Requested processing protocol for Donation following Cardiac Death /Arrest(DCD)
12. Remainder of organ / tissue recovery should be as consistent with organ transplant protocol (section above) as possible.

Includes organ flush with UW/SPS-1 or HTK until solution runs clear.
SECTION: Requested processing protocol for Donation following Cardiac Death /Arrest(DCD)
13. While warm ischemic time is to be minimized, tissues may be accepted up to 6 hours WIT, 12 hours in unusual circumstances where disease is rare and research critical


SECTION: Requested processing protocol for Donation following Cardiac Death /Arrest(DCD)
13.1. Times of cardiac death and beginning of cold perfusion of organ or cross clamp is to be recorded and reported with Metadata
SECTION: Preparation for Shipping
14. Recovery Team to package and ship such as to meet requirements of 49 CFR 172.700 and IATA 1.5.

Shipment is to reach HTC within 24 hours of recovery.
SECTION: Preparation for Shipping
15. Label each Specimen Bag or Rigid Container with project code, tissue, and recovery team donor number.
SECTION: Preparation for Shipping
16. Place Lung, Thymus, and Spleen tissues in the organ box on wet ice and maintain at 2-8°C until shipment.
SECTION: Preparation for Shipping
17. The Blood vial should be placed outside the organ box but within the shipping container within a biohazard bag. 

Recommend to cut a small well in the Styrofoam container for vial security. 

Blood sample should not be immersed or placed in direct contact with wet ice to avoid freezing and loss of WBC viability.
SECTION: Preparation for Shipping
18. HTC: Track case, arrange for transfer from courier to URMC HTC Processing Lab
SECTION: Metadata
19. Recovery team to provide clinical metadata to include at minimum:
1.cause and events occurring during hospitalization prior to death, 
2.any CPR required prior to determination of death, 
3.time of brain death (DBD), 
4.time of cardiac arrest (DCD), 
5.time of cross clamp and cold flush, 
6.donor age
7.gestational age at birth in weeks/days or born full term, 
8.demographics and anthropometrics including race and ethinicity, weight, height, 
9.medication exposure in hospital, 
10.number of days on mechanical ventilation leading up to recovery, 
11.most recent ventilator settings and minimum of last arterial blood gas with vent settings and FiO2, 
12.recent chest XRay reports including any CT/MRI type imaging, 
13.recent bronchoscopy reports, 
14.test results of any blood, urine, respiratory tract, including sputum, samples
15.recent CBC, 
16.current diagnoses, 
17.current serologies (at minimum HepB, HepC, HIV, syphilis, CMV, EBV), 
18.past medical history including diagnoses, 
19.medications taken at home, 
20.history of smoking, vaping, drugs of abuse, 
21.COVID-19 immunization and exposure history, 
22. results and dates of any viral testing including respiratory viral PCR panels and any confirmatory positive or negative testing for SARS CoV2 infection