1. Operations and Safety Committee Update
Hello Everyone, my name is ____________ from [name of organization]. I am a member of the Operations and Safety Committee.
Spring 2018

2. Subtyping
OPTN Policy 2.6.B Deceased Donor Blood Subtype Determination Can only use for allocation when no conflicting subtyping results
Conflicting results include those from transplant hospital or another lab if reported to the OPO prior to or during allocation
Committee is looking into providing clarification for OPOs
We would like to remind OPOs that they are not permitted to allocate based on subtype if they are aware of a conflicting subtype result.
This applies even if they have reason to believe that they have an accurate subtype, and a conflicting subtype is from another lab or a transplant hospital. Our Committee is aware that there may be confusion around what to do in certain situations with regard to subtype, and plans to discuss a path forward at our upcoming in person meeting in April.
If there are certain situations or circumstances that have raised subtyping questions in your program, I would be happy to take those back to the committee to include in those discussions. You can speak with me later today or our Committee chair or liaison.

3. Extra Vessels: Reducing Reporting Burdens and Clarifying Policies
Hello Everyone, my name is ____________ from [name of organization]. Today, I’ll be presenting the “Extra Vessels: Reducing Reporting Burdens and Clarifying Policies” proposal put forward by the Operations and Safety Committee.
Operations and Safety Committee

4. What problem will the proposal solve?
1. Modify Extra Vessel Sharing Requirements
Significant time to submit and review justification without value
2. Change Extra Vessel Label Policy Requirements & Align DonorNet and Label
Not enough room to list all disease results on label
OPOs cannot import results that aren’t in DonorNet
Test names do not align with test result options
3. Align OPTN Extra Vessel Policies with Final Rule
Final Rule states vessels (includes extra vessels) are considered part of organ and subject to organ allocation rules and policies
Many OPTN policy references need edits to meet this logic
This is a three-part proposal. We are addressing three areas:
1.) Extra vessel sharing
2.) Extra vessel labeling requirements, and
3.) How consistent the Extra vessel policy is with the Final Rule
First: The problem with current extra vessel sharing requirements is that policy requires you to submit a justification to the MPSC. This requirement creates unnecessary work with no added value.
Second: Policy requires all infectious diseases to be on the extra vessels label that is attached to the outermost layer of the triple sterile barrier but the system is not set up for this. It is challenging to respond to changes since DonorNet, Transnet and the label itself are all impacted by the change. Additionally, what is in DonorNet and what needs to be on the label are different.
Third: The Final Rule states that vessels, including those not attached to the organ which we call extra vessels, are considered part of the organ with which they are procured and “shall be subject to the allocation requirements and policies pertaining to the organ with which the blood vessel is procured until and unless the transplant center receiving the organ determines that the blood vessel is not needed for the transplantation of that organ.” Some OPTN policies fit within this logic but others need modifying to be consistent with this principle.

5. What are the proposed solutions?
1. Change Extra Vessel Sharing Requirements
Remove MPSC justification requirement
Require TIEDI reporting of sending extra vessels within 7 days
2. Change Extra Vessel Label Policy Requirements and Align DonorNet and Extra Vessels Label
Change label requirements from “all” infectious diseases to HIV, HBV, and HCV
Add TransNet barcode scan to access all DonorNet infectious disease results
Remove “unknown” test result option in DonorNet
Revise physical polyplastic label to have same test result options as DonorNet
We propose the following solutions:
First: We would remove the MPSC justification requirements that currently exist for the receiving transplant hospitals. Instead, we would require that the sending hospital use the existing TIEDI system to report within seven days that they sent the vessels.
Second, we propose these label changes:
Right now we require the OPO to put all infectious diseases on the outer vessel label. Instead we propose that they label only HIV, HBV and HCV results. We would add a bar code scan to the TransNet label that can pull up all infectious disease results in DonorNet.
We would align test result options in DonorNet and the physical label by eliminating “unknown” as an option in DonorNet and eliminating “N/A” but adding “Indeterminate” and “Not Done” to the physical label.

6. What are the proposed solutions?
3. Align OPTN Extra Vessel Policies with Final Rule
Add extra vessels exceptions or modifications where needed
Remove extra vessels citation where already covered-requirement still applies!
Examples of substantive areas:
PHS increased risk informed consent required in secondary recipient but can inform after surgery in emergent situations
Change verification requirements (secondary recipient or modification) to verify HIV, HBV, and HCV instead of “all”
Extra vessels can be used in emergencies without HIV screening but must complete testing before storage or other actions
To make OPTN policy consistent with the Final Rule we propose a number of language changes. They look like a lot of changes but for the most part they are not substantive. We add the word the word “extra” in front of vessels in all applicable places. We do have a definition for extra vessel in OPTN policy. We also eliminate the words “vessel” or “extra vessels” where they are not needed.
This is going to be a very important education point because if the policy applies to the organ it will still apply to the extra vessel.
There are some areas where clarification, exceptions, or changes are proposed.
For example, the policy that requires documentation of an organ abnormality would not apply to an extra vessels abnormality.
I am highlighting some of the changes that are substantive.
For consent of PHS increased risk organs-when a PHS increased risk extra vessel is stored and subsequently used, then the informed consent rule would apply. The Committee recognizes that might not always be possible in emergent situations so an exception is proposed to allow informing the recipient after use and then performing post-transplant testing as you would on a recipient of an increased risk donor.
Verification policy of vessels already exists. We are not proposing any changes except that verification would be only for HIV, HBV, and HCV instead of the current requirement for “all infectious diseases”
You can use extra vessels in emergency transplantation (excluding kidneys) before you screen for HIV like in current policy however you cannot store them or use them in another recipient unless you complete the screening and then regular policy rules would apply.
We don’t have time to go over every change but a table in Appendix A outlines all proposed changes.

7. Supporting Evidence: 1. Change Extra Vessel Sharing Requirements
: 157 justifications submitted and reviewed with no policy violations
98% of extra vessels dispositions already reported in TIEDI
2. Change Extra Vessel Label Policy Requirements and Align DonorNet and Extra Vessels Label
HIV, HBV, and HCV impact extra vessels storage
11% of EBV and 7-15% of Other results pending at labeling
Unknown only used in 10 cases-can be removed. N/A on label confusing
Allows flexibility for future changes and barcode scanning for most UTD results
3. Align OPTN Extra Vessel Policies with Final Rule
Staff found that half of policies analyzed need some change
These reasons support our proposed solutions:
First, for extra vessel sharing requirements-the MPSC is now reviewing over 50 per year. During 2016 and 2017, they reviewed 157 justifications and found no policy violations. Many transplant hospitals are already reporting sending extra vessels through TIEDI (34 did in 2016) as the capability exists now but is not required. Requiring to report sending extra vessels within seven days is consistent with all other reporting and will assure that tracking for infectious disease purposes can be done in a timely fashion.
Second, we are proposing to change the label policy requirements to HIV, HBV, and HCV only because these are the results that impact vessel use and storage. We will provide the bar code scan for all DonorNet results that will be a better solution to access the most-up to date results. Data shows that 11% of EBV and 7-15% of all “other” results are not completed at the time of TransNet data validation. By aligning DonorNet and physical label test result options we will eliminate confusion or decision making about what result to check when results must be hand written. The solution will also help us not become misaligned if new infectious diseases are added to policy.
Third, the supporting evidence for aligning policies with the Final Rule comes from a staff analysis of all OPTN policy references that might need changing. Staff identified 99 potential areas and found that 50 of them needed some edits or change to be consistent. Where there was any question the Committee was consulted and they came up with the solutions based on practicality as well as safety protection.

8. How will members implement this proposal?
Transplant Hospitals
Will have overall reduced burden
Receivers of extra vessels no longer submit justification
Senders of extra vessels must report in TIEDI within seven days
Educate staff that organ policies apply to extra vessels
Train extra vessels users how to read new extra vessels label and scan for additional results
To implement this proposal, we will need to educate the transplant community.
First-transplant hospitals will need to change their methods of how they report shared extra vessels to the OPTN. Sending extra vessels to other hospitals will need to be reported within seven days in the same way that destruction and transplant must be reported now.
For the second part of the proposal, transplant hospitals will need to become familiar with the new label and what it contains. If transplant hospitals plan to access the other infectious disease results using the bar code, then they will have to train staff on how to do this. They can do this using a mobile phone without a specific log in but they will have to go to the TransNet website. If transplant hospitals repackage extra vessels and make a new label, then they would need to purchase the new labels.
For the third part, transplant hospitals will need to educate staff. The most important part will be that the organ requirements, such as those for infectious disease reporting, apply to extra vessels even if the word vessels is no longer in policy.
Other changes such as clarifying that informed consent is needed when using PHS increased risk extra vessels in a secondary recipient might need staff education depending on what the transplant hospital currently does.

9. How will members implement this proposal?
Train staff on how to complete and place TransNet labels on revised extra vessels labels
Purchase and use the revised extra vessels labels
Educate staff organ policies apply to extra vessels
To implement this proposal, we will need to educate OPOs.
For the second part of the proposal, OPOs will need to purchase and use the new extra vessel labels. OPOs will need to become familiar with the new label and what it contains. They will need to train staff on printing two versus three TransNet labels and the placement on the new polyplastic label.
Data vendors might need to adjust their data files when the unknown option is eliminated as a test result option.
For the third part, OPOs will need to educate staff. The most important part will be that the organ requirements, such as those for infectious disease reporting, apply to extra vessels even if the word vessels is no longer in policy. OPOs will be given read access for vessels in TIEDI that they recovered to help comply.

10. Specific Feedback
What other infectious disease tests do OPOs perform due to travel history or local protocols that are not required by OPTN policy?
The Committee is going to consider adding other infectious disease tests to the DonorNet screening page to capture tests that are performed based on donor travel history or local protocols. We have seen an increase in OPOs conducting tests such as Strongyloides even though this is not required by OPTN policy. Based on the responses we receive during public comment, the Committee might propose programming additional tests in DonorNet so that they can be accessed through a TransNet scan or by viewing DonorNet without searching through the narrative.

11. How will the OPTN implement this proposal?
Anticipated Board Review date: June 11-12, 2018
Anticipated Implementation dates:
September 1, 2018 (Parts 1 and 3)
Upon programming and member notification (Part 2)
Programming in DonorNet, TIEDI, and TransNet
No additional policy compliance requirements
Proposal Part
Anticipated Implementation Date
1. Modify Extra Vessel Sharing Requirements
September 1, 2018
2. Change Extra Vessel Label Policy Requirements and Align DonorNet and Extra Vessels Label
Upon programming and member notification
3. Align OPTN Extra Vessel Policies with Final Rule
The Committee hopes to send the proposal to the OPTN/UNOS Board of Directors for June 2018 consideration. This policy would be a split implementation.
Parts 1 (Sharing requirement changes) and 3 (Alignment with Final Rule) would go into effect on the standard date of September 1, 2018 as no programming would be required.
Part 2 will require programming in DonorNet, TIEDI and TransNet as well as changing the physical extra vessels polyplastic label and therefore that part of the policy would not go into effect until programming/label change and member notification.

12. Questions? David Marshman, CPTC Operations and Safety Committee Chair
Susan Tlusty
Operations and Safety Committee Liaison

13. Extra Slides

14. Proposed DRAFT Extra Vessels Polyplastic and TransNet Labels

15. Comparison of Current and Proposed Test Result Options in DonorNet and Extra Vessels Label
Positive
Negative
Pending
Not Done
Indeterminate
Unknown
N/A
Current
Donor Net X
Extra Vessel Label
Proposed

16. Final Rule: Title 42: Public Health Part 121-Organ Procurement and Transplantation Network
§ Definitions.
Organ means a human kidney, liver, heart, lung, pancreas, intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract) or vascularized composite allograft (defined in this section). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled “For use in organ transplantation only.”

17. Final Rule: Title 42: Public Health Part 121-Organ Procurement and Transplantation Network
§ Identification of organ recipient.
(e) Blood vessels considered part of an organ. A blood vessel that is considered part of an organ under this part shall be subject to the allocation requirements and policies pertaining to the organ with which the blood vessel is procured until and unless the transplant center receiving the organ determines that the blood vessel is not needed for the transplantation of that organ.