Aligning OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation
Policy 14: Living Donation
14.4.B Living Kidney Donor Medical Evaluation Requirements
A medical evaluation of the potential living kidney donor must be performed by the recovery
hospital and by a physician or surgeon experienced in living donation. The goals of the medical
evaluation are all of the following:
1. To assess the immunologic compatibility of the living donor to the recipient
2. To assess the general health and surgical risk of donation to the living donor including
screening for conditions that may predict future complications from having only one kidney
3. To determine if there are diseases present that may be transmitted from the living donor to
the recipient
4. To assess the anatomy and function of the living donor’s kidneys
Documentation of the medical evaluation must be maintained in the donor medical record.
The medical evaluation must include all of the components in Table 14-2 below.
Table 14-2: Requirements for Living Kidney Donor Medical Evaluations
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Kidney Paired Donation (KPD) Histocompatibility Testing Requirements
Problem Statement
KPD matches can fail for a variety of reasons, but data show that a significant number of failed matches
in the OPTN KPD program are due to HLA antibody related issues. These changes are designed to
increase efficiency in the OPTN KPD program and prevent future match failures. Some of the changes
below are simply being moved from the OPTN KPD pilot program guidelines into OPTN policy.
Summary of Changes
HLA typing is required for donors and candidates in order to be eligible for match runs in the OPTN
KPD program
The potential donor’s hospital is responsible for all HLA reporting requirements on the donor
The transplant hospital registering the candidate in the OPTN KPD program is responsible for all HLA
reporting requirements on the candidate
HLA typing for donors and candidates must be performed using molecular methods
The following HLA types are required to be reported for potential donors in the OPTN KPD program:
HLA-A, B, Bw4, Bw6, C, DR, DR51, DR52, DR53, DQA, DQB, and DPB
The following types are required to be reported for candidates in the OPTN KPD program: HLA-A, B,
Bw4, Bw6, and DR
If a candidate has unacceptable antigens listed for the following, these additional types are required to
be reported for the candidate: HLA-C, DR51, DR52, DR53, DQA, DQB, and DPB
The candidate’s transplant hospital is responsible for retyping a matched donor to confirm the donor’s
HLA information
The candidate’s transplant hospital is responsible for testing the candidate for antibodies at all of the
following times:
1. every 90 days (+/- 20 days)
2. when a potentially sensitizing event occurs
3. if the candidate has been reactivated after being inactive for more than 90 days
4. if an unacceptable positive crossmatch occurs that precludes transplantation
Candidates must be screened for antibodies using a method at least as sensitive as the crossmatch
method and using a solid phase assay
The candidate’s physician or surgeon (or designee) and the affiliated histocompatibility laboratory
director (or designee) must review and confirm the unacceptable antigens reported for a candidate
before the candidate appears on the first KPD match run
1OPTN/UNOS Policy Notice
The candidate’s transplant hospital is responsible for performing a physical crossmatch before the
donor’s recovery is scheduled and a final crossmatch prior to the transplant. The candidate’s transplant
hospital must report crossmatch results to the matched donor’s hospital and the OPTN Contractor.
If an unacceptable positive crossmatch occurs between a candidate and a matched donor, the OPTN
Contractor will make the candidate ineligible for subsequent match runs until the candidate’s hospital
confirms that the physician or surgeon and the histocompatibility laboratory director have reviewed the
candidate’s unacceptable antigens.
The candidate’s hospital must report to the OPTN Contractor a reason for an unacceptable positive
crossmatch within 7 days of the date that the crossmatch results were received by the candidate’s
transplant hospital.
What Members Need to Do
These new policies apply only to transplant programs participating in the OPTN KPD program.
Once implemented, the KPD donor hospital will be responsible for all HLA typing for donors and for
arranging shipment of the donor blood sample to the candidate’s hospital or lab for the crossmatch.
The KPD candidate hospital will be responsible for:
All HLA typing for candidate and confirming the donor’s HLA type.
Performing and reporting antibody screenings at the required frequency.
Performing crossmatches at the specified times and communicating the results to UNOS and the donor
hospital.
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Requiring the Reporting of Aborted Living Donor Recovery Procedures
Problem Statement
Between 2008 and 2010, a series of aborted living-donor recovery procedures occurred at a member
program, resulting in non-recovery of the organ for transplant. These aborted procedures were reported
to UNOS through the Living Donor Feedback form, but since patient information reported on this form is
not designed to be monitored in real time, UNOS did not immediately identify the situation.
Summary of Changes
In addition to reporting aborted living-donor recovery procedures through the Living Donor Feedback
form, living donor recovery hospitals must also report these events by using the new living donor adverse
event category in the Improving Patient Safety Portal.
What Members Need to Do
Living donor recovery hospitals must report aborted living donor recovery procedures through the
Improving Patient Safety Portal within 72 hours of the event.
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Modifying or Establishing New Requirements for the Informed Consent of Living Donors
Problem Statement
In 2006, the Health Resources and Services Administration (HRSA) directed the OPTN to develop living
donor policies. New policies for the informed consent of living kidney donors went into effect on February
1, 2013. We still need related policies for the informed consent of other categories of living donors (liver,
pancreas, intestine, and lung).
Summary of Changes
Before these new policies were approved, living liver donor recovery programs were required to develop
and follow their own center-specific protocols related to the duties and responsibilities of their
Independent Living Donor Advocates (ILDAs) and the informed consent of their living liver donors. Living
donor (liver, pancreas, intestine, and lung) recovery hospitals will now follow new standardized
requirements for the informed consent of their living donors.
What Members Need to Do
Beginning Feb. 1, 2015, living donor (liver, pancreas, intestine, and lung) recovery hospitals must follow
new policy requirements for their ILDAs and for the informed consent of their living donors.
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Modify or Establish New Requirements for the Psychosocial and Medical Evaluation of Living Donors
Problem Statement
In 2006, the Health Resources and Services Administration (HRSA) directed the OPTN to develop living
donor policies. New policies for the psychosocial and medical evaluation of living kidney donors went into
effect on February 1, 2013. Related policies for the psychosocial and medical evaluation of other
categories of living donors (liver, pancreas, intestine, and lung) are needed.
Summary of Changes
Before these new policies were approved, living liver donor recovery programs were required to develop
and follow their own center-specific protocols for the psychosocial and medical evaluation of their living
liver donors. Living donor (liver, pancreas, intestine, and lung) recovery hospitals will now follow new
standardized requirements for the psychosocial and medical evaluation of their living donors.
What Members Need to Do
Before approval of these new policies, living liver donor recovery programs were required to develop and
comply with center-specific protocols for psychosocial and medical evaluation of their living donors.
Living donor (liver, pancreas, intestine, and lung) recovery hospitals will now follow new standardized
requirements for the psychosocial and medical evaluation of their living donors.
...
Proposed ABO Subtyping Consistency Policy Modifications
Problem Statement
In multiple sections of OPTN policy, different references are used for subtyping result categories that are
intended to mean the same thing. Use of the term “A2” is not technically correct because routine
subtyping technology only tests for the presence or absence of A1 antigens.
Summary of Changes
We will update all policies to use the same language when referring to subtyping result categories. All
applicable subtyping references will be updated to either:
Blood type A, non-A1
Blood type AB, non-A1B
What Members Need to Do
By May 1, 2015, you should familiaProblem Statement
In multiple sections of OPTN policy, different references are used for subtyping result categories that are
intended to mean the same thing. Use of the term “A2” is not technically correct because routine
subtyping technology only tests for the presence or absence of A1 antigens.
Summary of Changes
We will update all policies to use the same language when referring to subtyping result categories. All
applicable subtyping references will be updated to either:
Blood type A, non-A1
Blood type AB, non-A1B
What Members Need to Do
By May 1, 2015, you should familiaProblem Statement
In multiple sections of OPTN policy, different references are used for subtyping result categories that are
intended to mean the same thing. Use of the term “A2” is not technically correct because routine
subtyping technology only tests for the presence or absence of A1 antigens.
Summary of Changes
We will update all policies to use the same language when referring to subtyping result categories. All
applicable subtyping references will be updated to either:
Blood type A, non-A1
Blood type AB, non-A1B
What Members Need to Do
By May 1, 2015, you should familiaProblem Statement
In multiple sections of OPTN policy, different references are used for subtyping result categories that are
intended to mean the same thing. Use of the term “A2” is not technically correct because routine
subtyping technology only tests for the presence or absence of A1 antigens.
Summary of Changes
We will update all policies to use the same language when referring to subtyping result categories. All
applicable subtyping references will be updated to either:
Blood type A, non-A1
Blood type AB, non-A1B
What Members Need to Do
By May 1, 2015, you should familiarProblem Statement
In multiple sections of OPTN policy, different references are used for subtyping result categories that are
intended to mean the same thing. Use of the term “A2” is not technically correct because routine
subtyping technology only tests for the presence or absence of A1 antigens.
Summary of Changes
We will update all policies to use the same language when referring to subtyping result categories. All
applicable subtyping references will be updated to either:
Blood type A, non-A1
Blood type AB, non-A1B
...
Topic: Learn about policy changes approved at the November 2014 OPTN/UNOS board meeting (Read 3473 times)