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

 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 The Problem

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

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

 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 Concerns noted in Public Comment

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

Requirement CurrentProposedAlign CMS Timing Changes Two ABO results must be obtained for deceased and living donors Prior to incision Prior to recovery Prior to match run Prior to generation of donor ID Living donor recovery verification (time out) must be conducted Prior to leaving OR Prior to general anesthesia for donor Current Practice Expanded Deceased donor recovery verification (time out) must be conducted If organs remain in same OR suite Donor and organ info: All cases Recipient info: When intended recipient is known Living donor recovery verification (time out) must be conducted If organs remain in same OR facility All cases Eliminates verification when leaving donor OR New Conditional Actions Organ check-inNoneIf organ arrives from different OR suite no rule Pre-procedure ABO verification NoneIf recipient surgery starts prior to organ receipt no rule Substantive ABO Policy Changes

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

 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 ABO Determination: Changes from current policy

Deceased Donor 2 Blood types on separate occasions Living Donor 2 Blood types on separate occasions Blood type must be done not specific Candidate 2 Blood types on separate occasions Blood type must be done not specific ABO Determination: Alignment with CMS CMS OPTN

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

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

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

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

 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 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 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 ABO Verification (Time Out): Changes from current policy

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

Liver ABOi Registrations Add warning Address FMEA #3 Match Run Add candidate blood type on view Highlight ABO compatibility status with symbol ! ! Human factors tool will assist with verifications Subtype Second User Verification Align programming with current policy Program subtype to verified by second user Same process as is currently done for primary type Programming

 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 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 What Members will Need to Do

 Theresa Daly, MS, FNP Committee Chair  Regional Rep Name Region X Representative address  Susan Tlusty Committee Liaison Questions?

Extras if needed

Death Accidental ABO Transplant Wrong Organ Arrived Wrong Organ/Wrong Patient Not On Match Run Labeling errors ABO Testing issues Communication issues Changes to ABO data Near Misses Never Event

NumberFailure Mode 1 OPO releases organ to recipient not on match run 2 Blood type verification does not occur prior to implantation 3 Candidate erroneously listed as accepting an ABO incompatible (pediatric heart, liver) 4 Wrong organ arrived-not checked at arrival to verify correct organ arrived for the correct potential recipient 5 If intended recipient surgery begins prior to arrival, no requirement for blood source documentation availability to confirm compatibility prior to anesthesia 6 Blood samples are mislabeled (candidate) 7 Verification occurs without both source documents for recipient and donor 8 One blood sample sent and tested twice 9 Only one sample drawn and tested prior to match (no ABO confirmation by second sample) 10 No pre-transfusion specimen is available for testing 11 Blood samples are mislabeled (donor) Top Failure Modes