1. Proposal to Modify Sterile Internal Vessels Label
Operations and Safety Committee
Spring 2015

2. The Problem Sterile internal vessels label prone to error
Packaging and labeling of vessels #2 failure mode
Increase risk of accidental infectious disease transmission
Over 20 data fields marked using sterile pen in sterile field
Difficult to complete and read
Infectious disease results may not match hangtag label
Good day,
My name is X and I am the regional representative from the Operations and Safety Committee. Thank you for the opportunity to present our proposal to modify the sterile internal vessels label.
This project started when we received a recommendation from the Ad Hoc Organ Tracking Committee in June 2013 to eliminate or modify the sterile internal vessels label. That committee spearheaded the initial development of the Electronic Tracking and Transport (ETT) Project that is producing the TransNet application. During on-site discovery and field observations, project members saw first hand the difficulties in completing the current sterile internal vessels label and the subsequent errors involved. In addition, Northwestern University conducted a Failure Modes Effects and Criticality Analysis which identified packaging and labeling of vessels as the 2nd highest ranked failure mode.
Errors with this label can increase risk for accidental infectious disease transmission because of illegible or erroneous results.
Currently OPOs must complete a label that is only 2 by 4 or 2 by 5 inches using a sterile pen and mark 20 data fields while maintaining a sterile field. Sometimes the label gets wet and the ink runs. Sometimes, because of these issues, professionals have to redo the label and this adds time and effort to the packaging and labeling process.
If pending results are later updated on the hangtag poly-plastic label, there may be discordant results between the two labels since you can’t update the internal sterile label without disrupting the sterile field.

3. Extra Vessels Labels Sterile internal label Hangtag poly-plastic label
Before we go any further, I want to make sure that everyone knows exactly which labels we are talking about.
The sterile internal label is the one affixed to the rigid container holding the vessels which is the first layer of the required triple sterile barrier.
The hangtag poly-plastic label is the label that is attached to the outermost or third layer of the triple sterile barrier.
We are ONLY proposing changes to the sterile internal label. We will not change the hangtag poly-plastic label, which will continue to have all the same information it does today.
Sterile internal label
Hangtag poly-plastic label

4. Goal of the Proposal
Modify Policy 16.4.D (Internal Labeling of Vessels)
Reduce total data fields
Keep PHS Increased Risk field
Keep one critical and condensed data field for infectious disease results:
These vessels are from a donor positive for HIV, HBV, or HCV:  YES  NO  PENDING
The proposed changes will amend Policy 16.4.D (Internal Labeling of Vessels). The proposal contains a table that shows the required data fields for the sterile rigid container internal label and the hangtag poly-plastic outermost label.
We will keep the donor ID, ABO, and recovery date on the sterile internal vessels label. We will also keep the field that indicates whether the vessels are from a PHS Increased Risk Donor. What will change on the internal sterile vessels label is the section about infectious disease results. There will be one data field that will indicate whether the vessels are from a donor positive for HIV, HBV, or HCV.
This field will be marked yes if any test result (screening or NAT) is positive for any of these diseases. It will only be marked as “NO” if all results are back for all three diseases and all results are negative. If only some results are back and negative but others are still pending, then you would check the “PENDING” box.

5. Picture of Proposed Modified Label
Here is a picture of what the revised sterile internal label would look like. It is the label attached to the sterile rigid container. The hangtag poly-plastic label that goes on the outermost layer of the triple sterile barrier will NOT change.

6. How the Proposal will Achieve its Goal
Reduce chances for error by reducing data fields
Keep most critical information
Direct back to source documents
Education on vessels repackaging for transplant hospitals and OR staff
The proposal will achieve its goal by modifying policy and the label for the internal sterile vessels label. We will reduce the infectious disease fields on the internal sterile label to one question containing critical information. The label will contain a message to consult source documents.
In addition, the Committee is preparing some educational materials for hospitals that do repackage vessels and use them in secondary recipients. These materials will help them with maintaining sterility, proper labeling and repackaging, which will help improve compliance and storage in a triple sterile barrier. The educational materials will also offer best practices to reduce risk of erroneous information and accidental infectious disease transmission. This is especially important when vessels must be used in emergent situations in secondary recipients.

7. Supporting Evidence
Labeling and packaging of vessels: 2nd highest failure mode
Nearly 75% of deceased donors include vessels recovery
Vessels from HCV positive donors increased from 2.6% to 3.9%
Vessels from at-risk donors rose from 7.9% (“high risk”) to 19.5% (”increased risk”)
Data periods: Totals: 2008-first half 2014
Era comparison to first half 2014
I have covered some of these points in previous slides but I want to quickly review the supporting evidence.
Northwestern University identified labeling and packaging of vessels as the 2nd highest failure mode. They conducted a Failure Modes Effects and Criticality Analysis (FMECA) as part of the Electronic Tracking and Transport project in 2013.
Our data is from 2008 through the first half of In addition for the data used to identify increases we are comparing the cohort from to the cohort during the first six months of 2014.
Nearly 75% of deceased donor recoveries include vessels recovered and sent with at least one organ. This means that there is a high occurrence of OPOs having to complete vessels labeling and packaging.
Our proposal does not change the outermost hangtag poly-plastic label which should always be present even with stored vessels. Our proposal reduces but keeps the most critical information on the sterile internal vessels label based on trend data.
We have one data field for when vessels are from a donor positive for HIV (which will happen with the HOPE Act), HBV, or HCV. Vessels from HCV positive donors have significantly increased from 2.6% to 3.9%.
Vessels from at-risk donors significantly rose from 7.9% considered to be “high risk” donors to 19.5% considered to be ”increased risk” donors. The term we use to indicate at-risk changed from “high risk” for HIV to “increased risk” for HIV, HBV, or HCV with the 2013 amended guidelines issued by the US Public Health Service. The increase we have observed may be due to the 2013 change in the definition, an actual increase in “increased-risk” donors, or both.

8. Supporting Evidence
Of 46,857 vessels recovered, 816 (1.7%) used in secondary recipients
Of these, 63 (7.7%) were from high/increased risk
88 transplant hospitals used vessels in secondary recipients and 25 did more than 10 cases
See proposal for safety situation reports, audit details, disease transmissions
Data periods: Totals: 2008-first half 2014
Era comparison to first half 2014
Of 46,857 vessels recovered, however, only 816 or 1.7% of the total were reported as being used in secondary recipients. This percentage has remained stable over time even as overall reporting has increased. Of these 816 vessels, only 63 or 7.7% of those used in secondary recipients were from at-risk donors. The number and percentage of extra vessels being stored and used in secondary recipients is relatively small. These are the cases that pose the most risk if the vessels are not stored properly and are used in emergent situations without much time to consult source documents in DonorNet for results.
In addition, storage and use of extra vessels in secondary recipients is not uniform across the transplant community. Less than 40% or 88 transplant hospitals have reported using any extra vessels in secondary recipients. Only 25 transplant hospitals had more than 10 instances over a 6.5 year period. This means that the number of places and frequency of occurrence is relatively limited.
Our proposal also contains information on patient safety situation reports, audit details, and disease transmission of which there have only been two unintended cases since 2008.

9. What Members will Need to Do
OPOs will need to:
Train staff to properly complete label
Use revised sterile internal label starting September 1, 2015
Transplant hospitals will need to:
Familiarize staff to understand the new look and results on revised sterile internal label
What members will need to do:
OPOs will need to become familiar with the revised sterile internal label and train staff to properly complete label . They would need to start using the revised sterile internal label starting September 1, 2015.
Transplant hospitals will need to familiarize transplant and OR staff to understand the look and results on revised sterile internal label.
We are also developing educational materials on packaging, labelling, repackaging, and storage of vessels that we will encourage everyone to use.

10. Specific Requests for Comment
Should the positive indication for HBV be for:
1. Any positive HBV testing result OR
2. Solely for HBsAg positive results since storage of these vessels is prohibited by policy
We are seeking feedback on whether the positive indication sentence that contains HBV should be for any positive HBV testing result
or just limited to HBsAg positive results since storage of these vessels is prohibited by policy.

11. Questions? Theresa Daly, MS, FNP Committee Chair thd9003@nyp.org
Regional Rep Name Region X Representative address
Susan Tlusty Committee Liaison