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Patient Assessment and Management for Organ Donation (2.03)

Patient Assessment and Management for Organ Donation (2.03) - Policies, Clinical, UWHC Clinical, Department Specific, UW Organ and Tissue Donation

2.03



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 1 of 11
PURPOSE

The purpose of this policy is to define the procedures related to the assessment and management of
patients being evaluated for organ donation potential by University of Wisconsin Organ and Tissue
Donation (UW OTD). Patients will be evaluated and monitored jointly by donor hospital and UW OTD staff.
It is the policy of UW OTD to provide patient assessment and management in accordance with all
regulatory requirements.

FORMS

Serology Instruction Form
Hemodilution: Infusion & Transfusion Record form

POLICY

Patient Assessment
A. A patient will be initially evaluated for organ donation eligibility per UW OTD policy 2.01 or 2.07
B. The donor hospital staff will evaluate the patient and complete the appropriate, necessary
documentation of brain death per UW OTD policy 2.02 or documentation of futility of care for
potential donation after circulatory death (DCD) donors per UW OTD policy 2.07.
1. Donor hospital staff will provide the documentation to UW OTD.
2. A UW OTD organ procurement coordinator (OPC) will immediately review the
documentation to ensure accuracy and that all regulatory requirements are satisfied.
C. The coroner/medical examiner and district attorney of jurisdiction will be contacted per UW
OTD policy 2.05.
D. Consent for organ donation will be obtained from the legal next of kin (LNOK) per UW OTD
policy 2.06 or via first person authorization (FPA) documentation per UW OTD policy 2.15.
E. An OPC will review the patient’s medical records, perform a physical examination of the patient,
and obtain vital signs in collaboration with donor hospital staff.
F. All relevant information will be shared with the UW OTD medical director on call (MOC) and
applicable transplant programs.






POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 2 of 11
ABO Determination and Verification
G. The ABO (blood type) of the patient will be determined and verified prior to completing any
match runs. For an accelerated donation performed to avoid organ waste, the ABO verification
may be completed after executing the match run but before an organ is released to the
transplant hospital and this will be documented in the patient record.
H. Initial ABO testing completed at the donor hospital or the first ABO test completed at the
University of Wisconsin Hospital and Clinics (UWHC) for UWHC patients will be the primary
blood type (A, AB, B, O).
I. The donor hospital primary ABO or the first ABO test completed at UWHC for UWHC patients
will be drawn and resulted prior to collecting the second sample and prior to collecting samples
for serologies. The donor hospital or UWHC will provide the primary ABO results to the OPC.
J. If the primary ABO is O or B:
1. Donor hospital staff will collect another sample for ABO typing.
2. This sample will be sent with the tissue typing and serology samples to UWHC.
3. UWHC will complete the secondary ABO testing.
K. If the primary ABO is A or AB:
1. The OPC will review the transfusion records for patient for the past 120 days, to the best
of the OPC’s ability, and will assess if a red blood cell transfusion occurred at any time in
the past 120 days.
2. If no red blood cell transfusion occurred, donor hospital staff will collect the second
sample for ABO typing and subtyping. This sample will be sent with the tissue typing and
crossmatchingserology samples to UWHC. UWHC will complete the secondary ABO
testing including the subtype.
3. If a red blood cell transfusion occurred at any time during the past ten days, the OPC will
try to obtain a pre-transfusion sample.
4. If the donor hospital does have a pre-red blood cell transfusion sample:
i. The OPC will obtain the minimum sample required.
ii. The sample will be sent with the tissue typing and crossmatchingserology
samples to UWHC.
iii. UWHC will complete a secondary ABO testing including the subtype.
5. If the donor hospital does not have a pre-red blood cell transfusion sample or if the
sample is greater than ten days old, the OPC will:
i. Document this in the patient record
ii. Notify the UW OTD MOC



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 3 of 11
iii. Request donor hospital staff collect the second sample. This sample will be sent
with the tissue typing and serology samples to UWHC. UWHC will complete the
secondary ABO testing without subtyping.
iv. Use a blood type of A or AB (no subtyping) for allocation.
L. If the first subtyping completed by UWHC is A1 negative, non-A1, A2, A1B negative, non-A1B, or
A2B:
1. A second subtyping test will be completed using a pre-red blood cell transfusion sample
collected at a different time than the sample already used for the first subtyping.
2. If no red blood cell transfusions occurred, donor hospital staff will collect a second
sample for the second subtyping.
3. If the donor hospital has another pre-red blood cell transfusion sample collected at a
different time that the sample already tested, this will be used for the second subtyping.
4. If the donor hospital does not have another pre-red blood cell transfusion sample
collected at a different time than the sample already tested, the OPC will:
i. Document this in the UW OTD patient record
ii. Notify the MOC
iii. Use A or AB (no subtyping) for allocation.
M. If the subtyping is A1 negative, non-A1, A2, A1B negative, non-A1B, or A2B and a second
subtyping will occur:
1. The OPC will request the donor hospital complete the second subtyping and provide the
results to the OPC.
2. If the donor hospital is not able to perform the subtyping analysis (i.e. lab unable to
perform), then the OPC will arrange for the second pre-red blood cell transfusion sample
to be transported to UWHC for the second subtyping and UWHC will provide the results
to the OPC.
N. Verifying ABO results:
1. The OPC as the qualified healthcare professional per UW OTD policy 1.16 will verify that
the primary ABO, secondary ABO, and both subtyping results (if applicable) match. If
any result does not match:
i. The OPC will attempt to identify the cause of the discrepancy, if possible. If
conflicting results, subtyping will not be reported.
ii. The OPC will contact the MOC.
iii. The OPC will record this information in the patient record and will document the
discrepancy information in Donor Highlights in DonorNet.



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 4 of 11
2. One OPC will independently review all ABO and subtyping (if applicable) documents to
verify they match or the discrepancy is documented.
i. The approved documents to be used for the verification will be the original or a
copy of the original laboratory results in the EMR or faxed to UW OTD and will
not be any other documentation of blood type (for example, if the blood type is
also printed on the H&P or the blood transfusion record that states the blood
type, this is not acceptable as it was not generated by the laboratory). The OPC
will obtain a printed copy of the results.
ii. The OPC will document this verification by recording his/her signature, date, and
time on one of the results documents.
iii. This OPC will enter the ABO and subtyping (if applicable) results into the UW OTD
patient record and DonorNet.
3. A second OPC or a United Network for Organ Sharing (UNOS) staff member will complete
a second independent review of all ABO and subtyping (if applicable) documents.
i. If a second OPC will complete the second verification, he/she will record his/her
signature, date, and time on the same ABO results document where the first OPC
recorded his/her signature.
ii. The second OPC will complete the DonorNet verification.
iii. If UNOS staff will complete the verification, the OPC will fax all results documents
to UNOS and UNOS staff will complete the DonorNet verification.
O. Summary of ABO and subtypes to be used for allocation:
1. If the ABO is A with a subtype of A1 or the subtype is indeterminate: use “A”
2. If the ABO is AB with a subtype A1B or the subtype is indeterminate: use “AB”
3. If the ABO is A with a subtype of non-A1 or A1 negative (also known as A2) and the
second subtyping could not be completed: use “A” and document this in Donor
Highlights in DonorNet.
4. If the ABO is A with a subtype of non-A1 or A1 negative (also known as A2) and the
second subtyping was completed: use “A2”
5. If the ABO is AB with a subtype of non-A1B or A1B negative (also known as A2B) and the
second subtyping could not be completed: use “AB” and documented this in Donor
Highlights in DonorNet
6. If the ABO is AB with a subtype of non-A1B or A1B negative (also known as A2B) and the
second subtyping was completed: use “A2B”.



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 5 of 11
P. If UW OTD completed an expedited recovery to avoid organ waste and the ABO testing,
verification, and reporting process was not completed prior to running the match runs:
1. The reason will be documented in the UW OTD patient record.
2. If the final ABO and subtyping (if applicable) results are different than any initial ABO and
subtyping (if applicable) used to run a match, the OPC will re-run the match run.
3. All final testing, verification, and reporting steps will be completed before an organ is
released to a transplant hospital.

Calculating Hemodilution for Serology Samples
Q. After consent for organ donation or consent for serology testing has been obtained but before
serology testing is initiated, an OPC will obtain the intake and output data for all adult and
pediatric patients from approximately 48 hours before the serology testing sample will be
collected. There are various sources for the intake and output data such as emergency room
records, the inpatient hospital records and staff, the hospital blood bank, and/or emergency
medical services/MedFlight records.
R. The appropriate Hemodilution: Infusion & Transfusion Record form will be completed by the
OPC.
S. All intake and output data will be recorded and the hemodilution status will be calculated on the
form.
T. A second OPC will verify the hemodilution calculation. This verification will be documented on
the appropriate form per current workflow and filed in the patient record.
U. The MOC will be notified of the hemodilution status.
V. If the patient is hemodiluted, the OPC will attempt to locate a pre-transfusion or a qualified
blood sample that is not hemodiluted to be used for serology testing, as outlined in this policy.
W. If there is not a pre-transfusion or qualified sample available, serology testing will be completed
using the hemodiluted sample.
1. The patient will be classified as increased risk for disease transmission and the
appropriate personnel will be contacted per UW OTD policy 2.04.
2. The OPC will notify the UWHC HLA Lab.
3. The UWHC HLA Lab may request lymph nodes be recovered to conduct tissue typing and
cross-matching analysis. If this is requested, the OPC will discuss when to recover the
lymph nodes with the MOC.
X. The OPC will notify the appropriate tissue and eye banks about the sample status, hemodiluted
or non-hemodiluted status, and if the sample was collected pre-transfusion.



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 6 of 11
1. If the tissue bank will test for HTLV, an additional sample may need to be collected.
2. The HTLV test will usually be performed on a sample that was collected before organ
recovery by a UW OTD surgical recovery coordinator (SRC).
3. If the pre-recovery sample is hemodiluted, the tissue bank may need to abort tissue
recovery.
4. The tissue bank may request the organ recovery be delayed until the patient is no longer
hemodiluted.
5. The OPC will work with the tissue bank to coordinate any additional steps.
Y. All completed hemodilution forms will be filed in the patient record and provided to the
appropriate tissue and eye banks when the initial shared paperwork is provided.

Finding a Pre-Transfusion or Qualified Blood Sample
Z. If possible, UW OTD will not use the blood sample collected at the initial hospital admission for
serology testing because the coroner/medical examiner may need some or all of that sample
for his/her investigation.
AA. The OPC will call the applicable labs and/or blood banks at the donor hospital to try to locate an
extra or archived blood sample.
BB. If an extra or archived sample is located, a new Hemodilution: Infusion & Transfusion Record
form will be completed for the extra or archived blood sample.
1. The OPC will record the sample tube type/color, remaining volume, and the date and
time the sample was drawn on the form.
2. All intake and output data for 48 hours prior to the sample collection date and time will
be recorded and the hemodilution status will be calculated on the form.
CC. If the extra or archived sample is hemodiluted, the extra or archived sample will not be used and
a new sample (which is also hemodiluted) will be collected from the patient for serology
testing.
1. The patient will be classified as increased risk for disease transmission and the
appropriate personnel will be contacted per UW OTD policy 2.04.
2. The OPC will notify the UWHC HLA Lab. The UWHC HLA lab may request lymph nodes be
recovered to conduct tissue typing and cross-matching analysis. If this is requested, the
OPC will discuss when to recover the lymph nodes with the MOC.
DD. If the extra or archived sample is not hemodiluted, serology testing will be completed using the
non-hemodiluted extra or archived sample.



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 7 of 11
1. If the coroner/medical examiner is involved in the case, the OPC will call the
coroner/medical examiner to determine how much blood he/she will need for his/her
investigation.
i. This will be completed as soon as the hemodilution status is determined.
ii. The coroner/medical examiner will usually require yellow top tubes for a
toxicology screen and the serology testing is usually completed using a sample
from red or purple top tubes.
2. The lab and/or blood bank at the donor hospital that is storing the extra or archived
sample will release the sample to staff in the donor hospital. Some donor hospitals may
require paperwork to be completed to release the sample.
3. Donor hospital staff will notify the OPC once he/she receives the sample.
EE. If the extra or archived sample is not hemodiluted, a hemodiluted sample from the patient will
still be collected. The hemodiluted sample will be used as a back-up if the serology testing on
the non-hemodiluted sample cannot be performed.
1. The date and time the non-hemodiluted sample was collected will be recorded on each
sample tube. The date and time is how the serology testing lab will distinguish the
hemodiluted versus non-hemodiluted samples.
2. The donor hospital staff will place the non-hemodiluted and the hemodiluted sample in
the serology kit that will be delivered to the serology testing lab.
3. The OPC will call the serology testing lab to confirm the non-hemodiluted sample is a
large enough quantity to complete the entire serology testing panel.
i. The lab typically will require 7mL in a purple top tube and 5mL in a red top tube
to complete the entire serology testing panel.
ii. At least 7mL of blood in a purple top tube will be needed to complete the entire
serology testing panel except the EBV test.
iii. EBV testing will only be completed for the sample in a red top tube.
iv. If the non-hemodiluted sample is not large enough, the OPC will contact the MOC
to determine what specific tests in the panel will be completed using the non-
hemodiluted sample.
FF. The OPC will instruct the lab to complete serology testing on both the hemodiluted and non-
hemodiluted samples and will distinguish the samples by the date and time the samples were
drawn.

Serology Testing



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 8 of 11
GG. Serology testing for the patient will be performed.
HH.An OPC will fax the appropriate Serology Instruction Form to the donor hospital (adult or
pediatric if the patient weighs less than 50 kilograms).
II. The OPC will confirm with donor hospital staff that a serology kit is available in the hospital.
JJ. The OPC will provide donor hospital staff detailed instructions about collecting the samples if
the hospital does not have a serology kit.
KK. If the hospital does have a kit, the OPC will inform hospital staff that sample collection
directions are included in the kit.
LL. The OPC will instruct donor hospital staff to transport all of the samples to the donor hospital
emergency room for courier pick-up.
MM. The OPC will make travel arrangements with a courier to transport the samples from the
donor hospital to the serology testing lab and to the UWHC Emergency Room (ER).
NN. Additional confirmatory tests may be performed for positive serology results.
OO. The OPC will share the preliminary results with the MOC and record the results in the patient
record.
PP. A second OPC will verify the results per current workflow.
QQ. After the verification, the results will be shared with all potential transplant centers and
applicable tissue and eye banks.
RR. If any of the following infectious disease results are positive, UW OTD will notify the University
of Wisconsin Hospital and Clinics (UWHC) Infection Control Department within 72 hours after
the result is identified:
1. Hepatitis B Surface Antigen
2. Hepatitis B Core Antibody
3. Hepatitis C Virus (HCV) Antibody
4. Syphilis
5. HIV 1/2 Antibody Combination.
SS. The UWHC Infection Control Department will perform all necessary reporting procedures and
complete any follow-up with state and local health officials according to UWHC policy 13.04.
TT. Final serology results will be filed in the patient chart and provided to the appropriate tissue and
eye banks.

DRAI
UU. An OPC will conduct a DRAI (donor risk assessment interview) with a member of the patient’s
family or anyone identified as the best historian for the patient..



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 9 of 11
VV. The DRAI will be obtained through the use of a standardized questionnaire and completed with
the patient’s legal next of kin, significant other, and/or other individuals having knowledge and
insight consistent with the ability to answer the questionnaire to the highest degree of accuracy
achievable/available.
WW. As noted in the DRAI, if a patient is equal to or less than 18 months old regardless of
breastfeeding or is less than 5 years old and has been breastfed in the past 12 months, a
separate DRAI will be completed for the patient’s birth mother.
XX. The DRAI will be completed and signed, dated, and timed by the OPC. The signed document is
the official, final copy of the DRAI. Any additional data collection tools or documents used
during the interview that are not signed, dated, and timed, are not considered part of the
official, final DRAI.
YY. Based on responses from the DRAI, the OPC will determine if the patient is increased risk. This
will be verified by an additional OPC and relayed to the UW OTD MOC.


Patient Management
ZZ. An OPC will provide to donor hospital staff the applicable order set or suggested guidelines.
1. Orders will be provided for brain dead patients and suggested guidelines will be provided
for potential DCD patients.
2. The orders or suggested guidelines will include directives for procedures that are
intended to assist with patient management.
AAA. Complete metabolic panel including coagulation (CMP) will be performed by the donor
hospital and monitored by an OPC.
1. For brain dead patients, cardiac enzyme testing and pulmonary consults and evaluations
will be performed, as needed.
2. The following laboratory tests are required for all patients:
i. CBC, electrolytes, two blood cultures, urine culture, urinalysis within 24 hours of
cross clamp, ABG, chest x-ray, and serum glucose.
3. The following laboratory tests are required for each specific organ that is intended to be
recovered:
i. Kidney: Creatinine and BUN.
ii. Liver: AST, ALT, alkaline phosphatase, direct bilirubin, total bilirubin, INR (or PT if
INR not available), and PTT.
iii. Pancreas: Serum amylase and hemoglobin A1C (HgbA1C).



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 10 of 11
iv. Heart: Echocardiogram and 12 lead ECG.
v. Lung: Sputum gram stain, 12 lead ECG, bronchoscopy, and echocardiogram.
BBB. A chest x-ray will be obtained every 24 hours and reviewed by an OPC.
CCC. Blood, urine, and sputum cultures and a urinalysis will be performed.
1. The OPC will provide donor hospital staff with the appropriate order set or guidelines for
the cultures.
2. The OPC will contact donor hospital staff to verbally review the culture requests
together.
3. The culture samples will be collected by donor hospital staff and sent to the donor
hospital processing lab.
4. After the organ recovery time is scheduled with the operating room at the donor
hospital, the OPC will complete a final check to verify that all required UW OTD cultures
have been ordered.
5. This review will occur electronically or by calling donor hospital staff to verbally discuss.
6. If required cultures have not been ordered, the OPC will request hospital staff collect the
samples before recovery procedures in the operating room begin.
7. Any changes in culture results, including positive results, will be communicated to the
appropriate transplant centers within 24 hours after UW OTD is notified per UW OTD
policy 2.08.
DDD. Additional testing may be completed at the discretion of donor hospital and/or UW OTD staff.
EEE. Donor hospital staff and an OPC will monitor the patient and make every reasonable effort to
maintain and maximize the potential for all suitable organs to be recovered. The following data
will be monitored:
1. Blood pressure (arterial blood pressure preferred)
2. Heart rate
3. Central venous pressure
4. Temperature (core temperature)
5. Ventilator settings
6. Medications including antibiotic therapy
7. Periods of oliguria, anuria, or diabetes insipidus and the applicable treatments
8. Volume intake and output.
i. The volume intake type (crystalloid, colloid, blood, and blood products) and the
amount will be monitored for a minimum of 8 hours prior to recovery, if possible,
and for the duration of the recovery.



POLICY
Established Date: January 2001
Effective Date: 15 December
2016January 2018
Title: Patient Assessment and Management for
Organ Donation
Policy Number: 2.03

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 11 of 11
ii. The urine output will be monitored for a minimum of 8 hours prior to recovery, if
possible, and for the duration of the recovery.
FFF. Tissue typing will be performed by the UWHC HLA Lab. For potential kidney, kidney/pancreas,
or pancreas donation, the UWHC HLA Lab will enter the HLA data into DonorNet.
GGG. OPC staff will complete the match runs and organ allocation procedures for each organ
intended to be recovered per UW OTD policy 2.12.
HHH. If any increased risk for disease transmission criteria is identified, UW OTD policy 2.04 will be
followed.

REFERENCES

UW OTD Policies 1.16, 2.01, 2.02, 2.04, 2.06, 2.07, 2.08, 2.12, and 2.15
UWHC policy 13.04