The Long and Winding Road

From the Origins of an HIV Policy to the Development of the MELD System

Gloria Taylor, RN, MA, CPTC

United Network for Organ Sharing (UNOS)

National not for profit 501 C

Membership organization

Government contractor

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

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

General Policy Process National committee proposal

Public comment

Regional meetings

Final committee proposal

Board action

UNOS Regional Map

Evolution of HIV Policy

Precipitous Event

August 1986

First report of the transmission of HIV by an organ transplanted from a screened donor

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

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

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

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

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.

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

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

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

Present Policy

At the June 1992 UNOS Board meeting public comment was reviewed and the modified policy accepted

Organ Allocation and Transplant Candidate

Criteria

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

NOTA - 1984

Created a task force

April 1986 reported its recommendations

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

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

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

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

OPTN Policy Development

Allocation policies historically balanced justice and medical utility

Candidate listing criteria continued largely to be a program-specific function

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

Public Discussion Ensued

Resulting in a moratorium in 1999

Commissioned an IOM study

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

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

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

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

Determining Highest Medical Urgency Status

Public forums were held

Liver Disease Severity Scale Committee

Liver Committee

Public comment X 2

Regional Meetings

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

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)

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

Questions, Comments & Concerns

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

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)

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

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