Proposal to Modify ABO Determination, Reporting, and Verification Requirements

1. Proposal to Modify ABO Determination, Reporting, and Verification Requirements Operations and Safety Committee Spring 2015

2. The Problem • Accidental ABO incompatible transplants – rare but devastating • Safety gaps and risk • Varying requirements and complex language: • Deceased and living donation • Candidate and donor • OPTN and CMS • Compliance issues

3. Goal of the Proposal • Reduce risk of accidental ABO incompatible transplants • Increase transplant safety • Improve policy consistency and clarity • Further align requirements with CMS

4. How the Proposal will Achieve its Goal • Address safety gaps • Provide clarity and consistency in policy • Further align policies with CMS • UNetsm changes enhance system safeguards for intentional ABOi transplants

5. Concerns noted in Public Comment • OPOs conducting verification at recovery when the intended recipient is not known • Requiring on-site recovering surgeon to participate in verification • Additional requirements not needed given infrequency of unintended ABOi transplants • Proposed policy too prescriptive • Entire process was redesigned

6. General Public Comment Themes • Requests for the following: • no differences from CMS requirements • updated templates and electronic solutions • postpone policy requirements until after ETT (TransNetsm) implementation • Concerns about clarity of policy

7. Substantive ABO Policy Changes

8. ABO Determination: Core Principles Blood type and subtype results based on two laboratory tests • Reduce chance of allocation being done on one erroneous lab result Samples drawn on different occasions. With each collection, a separate patient identification and labeling procedure conducted prior to the blood draw • Reduce chance of “wrong blood in tube” due to misidentification or label error

9. ABO Determination: Changes from current policy • Remove OPO option to have one blood draw sent to two labs • Require protocol to have process when ABO primary types do not match • Exception clause for accelerated deceased donation cases

10. ABO Determination: Alignment with CMS OPTN CMS

11. ABO Reporting: Core Principles • Base reports on two lab results • Use source documents • Enter reports independently by two different users • Complete reports before becoming active in OPTN system

12. ABO Reporting: Changes from current policy • “Qualified health care professional” must report • Safer timing • Exception clause for accelerated deceased donation cases • Addresses living donor VCA reporting

13. ABO Reporting: Timing Changes CMS OPTN Prior to Match Run Prior to Incision Before organ recovery Prior to generate Donor ID Medical eval prior to donation Before recovery Prior to Active OPTN Wait List Before on tx hospital wait list

14. ABO Verification (Time Out): Core Principles Confirmation of critical information includes surgeon • Reduce chance of delayed or missed communication Confirmation done at critical points of hand-off or introduction of risk • Reduce chance of “wrong patient/wrong organ” and chance for accidental ABOi transplant Changes will address FMEA 1, 2, 4, 5, and 7

15. ABO Verification (Time Out): Changes from current policy • Deceased donor: Donor and organ info (All cases) Recipient info (When the intended recipient is known) • Living donor: All cases prior to general anesthesia • Timing and scope safer for all

16. ABO Verification (Time Out): Changes from current policy • Organ Check In • New • Conditional: When organ received from outside OR suite • Pre-Transplant Verification • New • Conditional: When surgery starts before organ arrives

17. ABO Verification (Time Out): Changes from current policy • All verification requirements now listed in responsible party policy • What must verified and what can be used as a verification source put in table format • Transplant surgeon and licensed health care professional included in pre-transplant verification

18. ABO Verification: Alignment with CMS OPTN CMS Intended Recipient is Known: Prior to recovery If organ in same suite: Before leave room and whenenter recipient room Intended Recipient is Known: Prior to recovery All: Prior to general anesthesia If organ in same facility; Before leave room and when enter recipient room All: Before removal donor organ After organ arrival, prior to transplant After organ arrival, prior to transplant

19. Programming

20. What Members will Need to Do • OPOs and Transplant Hospitals : • Define “qualified health care professional” in protocols and process for resolving primary blood type conflicts • Be familiar with required verification information and acceptable sources • OPOs : • Assure two blood type determination and reports completed before match run • Conduct deceased donor organ recovery verification • Rerun match if organ not allocated on initial run or if data are updated/reported

21. What Members will Need to Do • Transplant hospitals : • Conduct living donor organ recovery verification before anesthesia • Conduct organ check-in when organs arrive from different OR suite • Conduct pre-procedure verification when surgery starts before organ arrives

22. Questions? • Theresa Daly, MS, FNP Committee Chair thd9003@nyp.org • Regional Rep Name Region X Representative email address • Susan Tlusty Committee Liaison susan.tlusty@unos.org

23. Extras if needed

24. Never Event Near Misses

25. Top Failure Modes