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The Long and Winding Road
From the Origins of an HIV Policy to the Development of the MELD System
Gloria Taylor, RN, MA, CPTC
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United Network for Organ Sharing (UNOS)
National not for profit 501 C
Membership organization
Government contractor
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Organ Procurement and Transplantation Network
(OPTN) Elect board & set
committees
Create membership criteria & policies
Collect & report data
Provide secure computer system
Maintain waiting list & match run system
Assist with organ placement
Conduct professional education
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OPTN Committees
Communications Ethics Finance Histocompatibility International
Relations Membership &
Professional Standards
Minority Affairs OPO Organ Availability Organ Specific (K/P,
Liver & Intestine, etc.) Patient Affairs Pediatrics Transplant
Administrators
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General Policy Process National committee proposal
Public comment
Regional meetings
Final committee proposal
Board action
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UNOS Regional Map
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Evolution of HIV Policy
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Precipitous Event
August 1986
First report of the transmission of HIV by an organ transplanted from a screened donor
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Original Policy - May 31, 1988 Potential Donor
Test all potential donors with an FDA licensed screening test
Perform a donor history to determine if the potential donor is in a “high risk” group
UNOS would not share organs or tissues that repeatedly tested positive
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Original Policy - May 31, 1988 Potential Donor (continued)
An exception existed for extra renal organs in extreme medical emergencies, & the transplant surgeons had to notify the recipient or next of kin
Donor consent forms were encouraged to include language stating potential donors would be screened for medical acceptability and these tests could prevent donation
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Original Policy - May 31, 1988Potential Recipient
HIV-Ab testing should be a condition for candidacy
An asympotomatic HIV-Ab sero-positive recipient, should not be excluded from transplant candidacy
An HIV-Ab sero-positive with AIDS or AIDS-related complex should be excluded from candidacy
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Original Policy - May 31, 1988Additional Issues
Healthcare personnel caring for an AIDS antibody positive patient should be informed
Treatment of AIDS antibody positive patients should not be optional or discretionary
Disclosure of information comply with statutes
UNOS members were requested to adopt an overall policy to address special HIV-related problems
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Policy Amended - June 20, 1989
4.1.2 UNOS members shall not knowingly participate in the transplantation or sharing of organs from donors who are confirmed reactive for HIV-Ab by an FDA licensed screening test.
4.2 Testing for HIV-Ab shall be a condition of candidacy… Patients confirmed positive should undergo appropriate counseling.
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Policy Amended - June 20, 1989
(continued)
4.2.1 (added) ...but should be advised that they may be at increased risk because of immunosuppressive therapy. The last sentence was deleted.
4.6 (added) HTLV-I Screening
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Next AmendmentsDecember 1, 1991
Brought to the UNOS Board by the Ad Hoc Committee on Donor Testing at the November 6-7, 1991 meeting
Policy proposal 4.7 was recommended for distribution for public comment
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Next AmendmentsDecember 1, 1991
(continued) 4.7 Transplant Recipient HIV Reporting was
implemented December 1, 1991 concurrent with public comment submission
Transplant centers shall immediately notify the procuring OPO and UNOS when recipients test positive for HIV or die from HIV-related causes
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Present Policy
At the June 1992 UNOS Board meeting public comment was reviewed and the modified policy accepted
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Organ Allocation and Transplant Candidate
Criteria
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A long, long time ago… B.U. Allocation & transplant
candidate listing criteria were handled by the programs
Allocation progressed to a network-type mechanism
Candidate criteria remained the purview of transplant programs
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NOTA - 1984
Created a task force
April 1986 reported its recommendations
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Task Force Recommendations
Establish a single national network for organ sharing
Participants will agree on & adopt uniform policies and standards
Each donated organ is a national resource to be used for public good
Public must participate in the decisions of how this resource can be used to best serve the public interest
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Task Force Recommendations
(Continued) Selection of patients for waiting lists and
allocation of organs be based on publicly stated medical criteria and be fairly applied
Develop criteria for prioritization through a broadly representative group taking into account both need & probability of success
Selection of patients otherwise equally medically qualified should be based on length of time on the waiting list
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Task Force Recommendations
(Continued) Selection of patients for transplant not be subject to favoritism, discrimination on the basis of race, gender, or ability to pay
Organ sharing concepts that are designed to improve the probability of success be implemented in the interests of justice and effective use of organs
Ongoing assessment of mandated organ sharing to identify & rectify imbalances that may reduce access by any group
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Creation of the OPTN
1986 - UNOS was awarded a contract to establish the OPTN
1987 - UNOS was awarded a contract to operate the OPTN
1988 - Reauthorization of NOTA• OPTN shall establish membership criteria
& medical criteria for organ allocation
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OPTN Policy Development
Allocation policies historically balanced justice and medical utility
Candidate listing criteria continued largely to be a program-specific function
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A Bump in the Road April 2, 1998
Department of Health and Human Services (HHS)
Organ Procurement and Transplantation Network; Final Rule
60-day public comment
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Public Discussion Ensued
Resulting in a moratorium in 1999
Commissioned an IOM study
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Results of the OPTN Final Rule
The OPTN will develop:
Criteria aimed at allocating organs first to those in the highest medical urgency status, with reduced reliance on geographical factors
This should reduce disparities in waiting times
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Results of the OPTN Final Rule
(Continued) Criteria to be followed in
deciding when to place patients on the waiting list
Medically objective criteria to be used by all transplant centers
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Results of the OPTN Final Rule
(Continued) Criteria for determining the
status of patients who are listed
Medically objective, uniform criteria would help ensure a “level playing field” in selecting patients & determining greatest medical need
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Organ Specific Criteria
Minimum listing criteria were already being developed
Pediatric and adult liver criteria are policy
Heart, Lung & Heart-Lung criteria are presently guidelines
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Determining Highest Medical Urgency Status
Public forums were held
Liver Disease Severity Scale Committee
Liver Committee
Public comment X 2
Regional Meetings
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Result: MELD System Model for End Stage Liver Disease
Based on short term risk of death without a liver transplant (3 months)
Formula that is calculated based on medically objective, uniform criteria
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Suggested Elements of the Liver Disease Severity
Score Bilirubin cholestatic, INR , Albumin, &
Creatinine Hepatocellular Carcinoma Spontaneous Bacterial Peritonitis TIPS (contraindications were noted) Intubated Chronic bleeding ( 3 days over 7 days)
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Additional Suggestions The scale be tested & refined
Other predictors of mortality (i.e., cholangitis, hepatopulmonary syndrome, and non-liver comorbidities) eventually be included in the scale to improve its predictive accuracy
There should be an inclusive national forum held
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Questions, Comments & Concerns
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OPTN/UNOS Ethics Committee
Supports the basic concept demonstrated by the MELD ideology
Believes identifying patients at greatest risk of dying is well founded in the ethical principle of justice
However, the use of organs for critically ill patients for transplant may not demonstrate the ethical principle of medical utility
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OPTN/UNOS Ethics Committee (Continued)
Recommends continued evaluation in the realm of medical utility
Recommends periodic reviews of the outcomes to ensure that no specific group is disadvantaged (i.e., the use of serum creatine vs. creatine clearance as an element of the MELD system may disadvantage women)
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Next Steps Liver Disease Severity
Scale Committee met July 25, 2001
Liver Committee met July 26, 2001
HIV+ candidate concerns were on the agenda
Modifications are still occurring
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Concluding Remarks
Policy-making regarding organ transplantation has never suffered from inertia
Use the existing mechanisms to allow your voice to be heard
Offer to present to the appropriate committees