1. VCA Data Collection and Submission
Vascularized Composite Allograft
Transplantation Committee
Fall 2014

2. The Problem
No centralized data collection on VCA transplant recipients in the U.S.
The OPTN must:
Collect data on all organ transplant candidates, recipients, and donors in the U.S.
Respond to public data requests
Provide data to OPTN members
To date, there is no systematic, centralized data collection for VCA transplantation in the United States.
The Final Rule requires the OPTN to not only collect and maintain data on all organ transplant candidates, but to respond to all public data requests and provide data back to OPTN members.
Under the Final Rule, the OPTN shall:
Maintain and operate an automated system for managing information about organ transplant candidates, recipients, and donors;
Maintain records of all organ transplant candidates, recipients, and donors;
Operate, maintain, receive, publish, and transmit such records and information electronically; and
Provide manuals, forms, flow charts, operating instructions, or other explanatory materials as necessary to understand, interpret, and use the information accurately and efficiently.
Additionally, the OPTN is required to:
Respond to reasonable requests from the public for data needed for bona fide research or analysis purposes, to the extent that the OPTN's or Scientific Registry's resources permit, or as directed by the Secretary.
Provide data to an OPTN member, that has been assembled, stored, or transformed from data originally supplied by that member.

3. Goals of the Proposal
Centralize data collection on all U.S. VCA organ transplants
Comply with requirements of the OPTN contract
Support the scientific advancement of VCA transplantation in the U.S.
Align VCA data submission requirements with requirements for other, non-VCA organs
Goals of the proposal:
With VCA transplants now under the OPTN umbrella, we need to create a data collection process for all VCA transplants - one that complies with all of the OPTN contract requirements, which have been set forth by the Secretary of HHS, the Final Rule, and NOTA.
We also need to make sure that the VCA data we require members to submit aligns with the data submission requirements of other non-VCA organs.

4. How the Proposal will Achieve its Goal
Transplant Recipient Registration (TRR) and Transplant Recipient Follow-up (TRF) forms to collect:
VCA-specific data elements
Elements to measure VCA organ function
Policy revisions (18.1 and 18.2) to include VCA data submission requirements
Candidate List, Candidate Removal Worksheet, TRR, TRF
In order to properly fulfill the requirements set forth by the Secretary of Health and Human Services, the OPTN Final Rule, and the National Organ Transplant Act (NOTA), the VCA Committee recommended a list of data elements that need to be collected on all VCA transplant recipients.
We will use the Transplant Recipient Registration (TRR) and Transplant Recipient follow-up (TRF) forms to collect VCA-specific data elements as well as the data needed to measure levels of VCA organ function.
Since programming a new organ type into UNOS’ existing electronic infrastructure would require a significant amount of time and resources, we will manage the VCA transplant data collection instead using a Microsoft Access database through a secure SharePoint site.
We will also revise Policy 18.1 and 18.2 to include data submission requirements for VCA organ transplant candidates, recipients, and donors on the following forms:
VCA Candidate List
Candidate Removal Worksheet
TRR
TRF

5. Rationale for Data Collection
Early stage of VCA transplantation
Answer critical questions:
Patient safety and outcomes
Patient and graft survival
Functional restoration in VCA recipients
Data collection for VCA recipients is critical at this early stage of VCA transplantation.
The rationale for collecting data on VCA recipients is to answer critical questions on:
Patient safety and outcomes (such as the use and complications of immunosuppression for life-enhancing, in the case of VCAs, rather than life-saving transplants)
In addition to considerations for patient and graft survival, functional outcomes are an essential measure of success and justifying the risk benefit ratio of the procedure itself.
Justifications for proposed data elements based on OPTN principles of data collection can be found in the public comment document, and they primarily include evaluating outcomes for developing transplant, donation, and allocation policies and ensuring patient safety.

6. Proposed Data Collection
Retain elements collected for other organs that are applicable to VCA
Socio-demographics
Insurance/payment information
Functional status
Diagnosis
Medical condition
Viral detection
Previous malignancy
Acute rejection
Immunosuppression
The proposed data collection consists of elements already collected for other, non-VCA organs, such as:
Socio-demographics
Insurance/payment information
Functional status
Diagnosis
Medical condition
Viral detection
Previous malignancy
Acute rejection
Immunosuppression

7. Proposed Data Collection
VCA organ function
Disability measure, functional and sensibility tests for upper limb transplants (DASH, Carroll Test, Semmes-Weinstein)
Sensory tests (2 point discrimination), motor function, and speech intelligibility for craniofacial transplants
Post-transplant outcomes
Major complications (diabetes, metabolic, infectious)
Graft and patient survival
In addition, proposed VCA-specific data elements include fields related to VCA organ function, such as:
The DASH score as a measure of upper limb disability
Carroll and Semmes-Weinstein tests for measuring function and sensibility of upper limbs
Sensory tests (such as 2 point discrimination and hot/cold testing) for craniofacial recipients
Motor function and speech intelligibility tests for craniofacial recipients
And fields related to post-transplant outcomes, such as:
Major complications, including new diabetes onset, metabolic or infectious complications
Graft and patient survival
Refer to the public comment document for a complete list of proposed data elements.

8. What Members will Need to Do
Transplant Programs must complete TRR and TRF forms for VCA recipients
Submit the following (Policies 18.1 and 18.2):
For OPOs:
VCA Candidate List
For Transplant Programs:
Candidate Removal Worksheet
TRR
TRF
Transplant Programs must complete TRR and TRF forms for all VCA recipients. When the VCA database is functional, you will need to obtain a user ID and password to access the database and submit the TRR and TRF. We expect the database to be functional in the Spring of 2015.
OPOs and Transplant Programs will need to be familiar with Policies 18.1 and and understand the requirements related to submitting information on organ donors from which VCA grafts were recovered. In addition to current requirements, you will also have to submit the following:
For OPOs
VCA Candidate List
For Transplant Programs
Candidate Removal Worksheet within 24 hours of transplant
TRR within 60 days of removal from the Waiting List
TRF within 30 days of the six month or one year anniversary, or within 14 days of graft failure
OPOs will:
Continue to use DonorNet® to register all donors, including those donors from whom only VCA grafts are recovered, and complete Donor Feedback – remember to indicate VCA donor in the donor highlight.
Continue to complete Deceased Donor Registration forms for all donors, including those donors from whom only VCA grafts are recovered which is outlined in Table 18-1.
Continue to submit completed VCA Candidate lists recording VCA organ allocation to the OPTN which is outlined in Table 18-1.
If you recall, specific instructions were sent to all OPO Executive Directors prior to the implementation of VCA policies and bylaws. This document can be found on the TransplantPro website.
Member transplant programs will:
Continue to register and remove VCA candidates by using the standard worksheets provided by the OPTN as outlined in Table 18-1.

9. Questions? Sue V. McDiarmid, M.D. Chair, VCA Committee
Christopher L. Wholley, M.S.A., NRP, CPTC
Committee Liaison