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Proposal to Revise OPTN/UNOS Data Release

PoliciesData Advisory Committee

Fall 2015

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What problem will the proposal solve? UNOS must operate the OPTN in accordance with the Final

Rule

Final Rule requires the OPTN to release OPO- and hospital-identified data data needed for bona fide research or analysis purposes data needed to assess performance of the OPTN or SRTR data needed to assess individual transplant programs and OPOs

Current OPTN/UNOS policy prevents release of OPO- and hospital-identified data Therefore, current policy is not consistent with Final Rule

Revise OPTN/UNOS policy to be in accordance with the Final Rule

What is the goal of the proposal?

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After discussion with HRSA, DAC replaced specific data release criteria in Policy 19 with the following: “The OPTN Contractor will release OPTN data according to the

Final Rule and other applicable federal and state laws and regulations. The OPTN Contractor will release all OPTN data requested by the Secretary of the Department of Health and Human Services.”

Created a Standard Operating Procedure for Review of OPTN Data Requests that will be made publicly available

How does the proposal address the problem statement?

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Staying the same: Detailed center-specific data available through PSRs OPO reports available through SRTR OPTN will review requests for reasonableness

HRSA must approve all patient-identified data requests HIPAA and the Privacy Act bind the OPTN’s release of patient-identified data All requestors must submit and abide by a data use agreement

Changed: New policy allows release of de-identified data with institution identifiers

Potential impact: will allow analysis of institution-level data

How will this be different in practice?

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Members do not need to do anything to comply with this policy

Members should review the Standard Operating Procedures for Review of OPTN Data Requests

How will members implement this proposal?

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Strategic Goal: Promote the efficient management of the OPTN This proposal makes OPTN policy consistent with the

requirements of the Final Rule.

How does this proposal support the OPTN Strategic Plan?

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Charlie Alexander, RN, MSN, MBACommittee Chair calexander@thellf.org

Liz Robbins Callahan, Esq.Committee Liaison Liz.robbins@unos.org

Questions?

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Extra Slides: Standard Operating Procedures for

Review of OPTN Data Requests

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The OPTN Contractor reviews all requests for OPTN data according to the Final Rule and other applicable federal and state laws and regulations and, as allowed in the Final Rule, can impose reasonable charges for the separable costs of responding to data requests.

General Statement

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Requests for Person Identified Data

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If the requestor is… Then the OPTN Contractor may release the following person-identified data:

An individual Data pertaining to that individual

Anyone granted authorization to receive information about an individual

Data pertaining to that individual

A member Data previously submitted by that member to the OPTN Contractor Data that are necessary for that member to prepare a report required by the OPTN Contractor Data that enable the OPTN Contractor to fulfill its obligations under the OPTN contract

An OPO Recipient characteristics and outcomes data for each transplanted organ that was recovered by that OPO

A transplant hospital

Recipient characteristics and outcomes for each organ offer received by that transplant program

Whether the transplant program’s candidate is registered on the waiting list at more than one transplant program, according to Policy 3.4.G: Multiple Transplant Program Registrations.

A transplant hospital or its affiliated histocompatibility laboratory

Prior donor’s HLA information for any recipients under that transplant program’s care

A histocompatibility laboratory HLA information of deceased donors and recipients typed by that laboratory when discrepant HLA information is reported to the OPTN Contractor

Anyone authorized to receive data, according to federal laws and regulations

Data approved by the U.S. Department of Health and Human Services (HHS), according to federal laws and regulations

Before receiving person-level de-identified data from the OPTN Contractor, requestors must submit a signed data use agreement (DUA) to the OPTN Contractor. The DUA must contain both of the following agreements: The requestor agrees to neither attempt, nor permit others to attempt, to learn

the identity of any person whose information is contained in the data. The requestor agrees to include the disclaimer in the signed DUA in any

publication using the released data.

Requests for Person-Level De-Identified Data (e.g., STAR files)

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The OPTN Contractor will release confidential information if the following requirements are met:

Requests for Confidential Information

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The requestor is at least one of the following:

And both of the following are true:

• Bound by a fiduciary responsibility to the OPTN Contractor

• Contractually obligated to the OPTN Contractor to maintain the confidentiality of the released information

• Acting on behalf of the OPTN Board of Directors

• Acting on behalf of an OPTN Committee

1. The request is necessary to perform an OPTN function on behalf of the OPTN Board of Directors or an OPTN Committee

2. The OPTN Contractor approves the request

The OPTN Contractor will release contact information for personnel at member institutions only if both of the following requirements are met: The requestor submits a signed data use agreement (DUA) to the OPTN

Contractor The OPTN Contractor approves the request

Requests for Personnel Information at Member Institutions

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