Operations and Safety Committee Update Spring 2018
The Operations and Safety Committee addresses key issues like deceased donor blood subtype determination, extra vessels reporting policies, and proposed solutions for modifying sharing requirements and aligning policies with the Final Rule to streamline organ allocation processes.
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Operations and Safety Committee Update Spring 2018 1
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 2
Extra Vessels: Reducing Reporting Burdens and Clarifying Policies Operations and Safety Committee 3
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 4
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 5
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 6
Supporting Evidence: 1. Change Extra Vessel Sharing Requirements 2016-2017: 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 7
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 8
How will members implement this proposal? OPOs 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 9
Specific Feedback What other infectious disease tests do OPOs perform due to travel history or local protocols that are not required by OPTN policy? 10
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) Proposal Part 1. Modify Extra Vessel Sharing Requirements Anticipated Implementation Date September 1, 2018 Upon programming and member notification (Part 2) 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 September 1, 2018 Programming in DonorNet, TIEDI, and TransNet No additional policy compliance requirements 11
Questions? David Marshman, CPTC Operations and Safety Committee Chair David.Marshman@lifelinkfound.org Susan Tlusty Operations and Safety Committee Liaison Susan.tlusty@unos.org 12
Extra Slides 13
Proposed DRAFT Extra Vessels Polyplastic and TransNet Labels 14
Comparison of Current and Proposed Test Result Options in DonorNet and Extra Vessels Label Test Result Options Positive Negative Pending Not Indeterminate Unknown N/A Done Current Donor Net X X X X X X Extra Vessel Label Proposed X X X X Donor Net X X X X X Extra Vessel Label X X X X X 15
Final Rule: Title 42: Public Health Part 121-Organ Procurement and Transplantation Network 121.2 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. https://www.ecfr.gov/cgi-bin/text- idx?SID=bb60e0a7222f4086a88c31211cac77d1&mc=true&node=pt42.1.121&rgn=div5#se42.1.121_12 16
Final Rule: Title 42: Public Health Part 121-Organ Procurement and Transplantation Network 121.7 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. https://www.ecfr.gov/cgi-bin/text- idx?SID=bb60e0a7222f4086a88c31211cac77d1&mc=true&node=pt42.1.121&rgn=div5#se42.1.121_12 17
