Enhancing ABO Determination and Reporting in Transplant Safety

Modify ABO Determination, Reporting, and Verification Requirements (Resolution 14) Operations and Safety Committee Ms. Theresa Daly

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

Strategic Plan #4- Promote Transplant Patient Safety Strengthen policy to reduce risk for unintended ABO incompatible transplant #5- Promote Living Donor Safety Strengthen policy to reduce risk for unintended ABO incompatible transplant #6-Promote Efficient Management of OPTN Provide clarity to requirements and promote electronic solutions to support policies

Goal of the Proposal Reduce risk of accidental ABO incompatible transplants Increase transplant safety Improve policy consistency and clarity Align requirements

How the Proposal will Achieve its Goal Align policies with CMS where possible Address safety gaps with policy changes identified by FMEA Consistent requirements and language between: Donors and candidates Deceased and living donation Develop educational tools including proficiency testing Programming enhancements

Overall Project Impact Product Policy Programming Professional Education Target Population Impact: All donors and candidates Total IT Implementation Hours 750/10,680 750 0 1000 2000 3000 4000 5000 Total Overall Implementation Hours 2,240/17,885 2240 0 2000 4000 6000

Public Comment Feedback Public Comment Response Tally No Vote/ No Comment/ Did Not Consider In Favor as Amended Type of Response Response Total In Favor Opposed Individual 24 16 (67%) 0 3 (13%) 5 (20%) Regional 11 7 (64%) 0 4 (36%) 0 Committee 19 1 (5%) 1 (5%) 1 (5%) 16 (85%)

Comment Themes Concerns related to OPO requirements o Ability to conduct verification at recovery when the intended recipient is not known o Requirement to have on-site surgical team participate in verification Concerns that the proposed policy was too prescriptive Concerns that additional requirements were not needed given the infrequency of accidental ABO incompatible transplants

Never Event Death Accidental ABO Transplant: 5 Since 2006 Wrong Organ Arrived Wrong Organ/Wrong Patient: 9 2009-2012 Not On Match Run: 240 Data entry issues: 9 1/2012- 6/2014 ABO Testing issues: 9 Communication issues: 8 Labeling errors: 63 Near Misses 2009-2012 Changes to ABO data: 329

Comment Themes Request for updated templates and electronic solutions Desire to postpone policy requirements until after ETT implementation Concerns that the entire process has been redesigned Desire to have no differences from CMS requirements

ABO Process Steps

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

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 (FMEA #9) 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 (FMEA # 6,8, and 11)

ABO Determination: Changes from current policy Remove OPO option to have one blood draw sent to two labs Post public comment to align with CMS Require protocol to have process when ABO primary types do not match Post public comment Exception clause for accelerated deceased donation cases

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

ABO Reporting: Core Principles Reports based on two results Source documents used for reports Reports entered independently by two different users Reports completed prior to becoming active in OPTN system Address FMEA #1 and #9

ABO Reporting: Changes from current policy Must be done by qualified health care professional as defined in member s protocol Exception clause for accelerated deceased donation cases Timing is made safer for deceased and living donors Address living donor VCA reporting Post public comment

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

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

ABO Verification (Time Out): Changes from current policy Deceased donor when the intended recipient is known Post public comment to align with CMS Living donor all cases prior to general anesthesia Timing and scope is made safer for deceased and living donors

ABO Verification (Time Out): Changes from current policy Organ Check In New-Conditional when organ received from outside OR suite Addresses FMEA #4 Pre-Transplant Verification New-Conditional when surgery starts prior to organ arrival Addresses FMEA # 5, # 2

ABO Verification (Time Out): Changes from current policy All verification requirements now listed in responsible party policy Post public comment for clarity Includes list of ID elements and acceptable verification sources Post public comment more detailed for clarity Transplant surgeon and licensed health care professional included in pre-transplant verification Post public comment to align with CMS

Sample Table of Verification Requirements Information to Verify: Acceptable Verification Sources: External and internal organ package labels Documentation with organ Organ received Donor ID Organ (and laterality if applicable) Donor blood type and subtype source documents Donor blood type and subtype (if used for allocation) Recipient identification band Recipient unique identifier Recipient blood type source documents Recipient medical record OPTN computer system Recipient medical record Attestation following verification of donor and recipient blood types Recipient medical record OPTN computer system Recipient blood type Donor and recipient are blood type compatible (or intended incompatible) Correct donor organ has been identified for the correct recipient

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

Substantive ABO Policy Changes Requirement Current Proposed Align with CMS incision Timing Changes Two ABO results must be obtained for deceased and living donors Living donor recovery verification must be conducted Deceased donor pre recovery verification (time out) must be conducted Living donor recovery verification (time out) must be conducted Prior to incision Prior to recovery Prior to match run Prior to generation of donor ID Prior to general anesthesia for donor Prior to leaving OR incision Current Practice Expanded to All Cases If organs remain in same OR suite All cases OPO If organs remain in same OR facility All cases Eliminates verification when leaving donor OR If organ arrives from different OR suite If recipient surgery starts prior to organ receipt New Conditional Actions Organ check-in None no rule Pre-procedure ABO verification None no rule

Programming Liver ABOi Registrations Match Run Add warning Address FMEA #3 Add candidate blood type on view Highlight ABO compatibility status with symbol ! ! Human factors tool will assist with verifications

Resolution 14 (page 31) RESOLVED, that additions and modifications to Policies 1.2 (Definitions), 2.6 (Deceased Donor Blood Type Determination and Reporting), 2.15.B (Organ Procurement Procedures) 3.3 (Candidate Blood Type Determination and Reporting before Waiting List Registration), 5.4.B (Order of Allocation), 5.5.A (Receiving and Reviewing Organ Offers), 5.6 (Blood Type Verification Upon Receipt), 5.7 (Released Organs), 13.6.A (Requirements for Match Run Eligibility for Candidates), 13.6.B (Requirements for Match Run Eligibility for Potential KPD Donors), 14.4.A (Medical Evaluations for Living Donors), 14.6 (Registration and Blood Type Verification of Living Donors before Donation), 16.1 (Organs Not Requiring Transport), and 16.4.C (Internal Labeling of Blood and Tissue Typing Materials) as set forth below, effective May 1, 2015. and

Resolution 14 (page 31) FURTHER RESOLVED, that programming modifications to ABO incompatible liver registrations and match run displays for candidate blood type and compatibility status as set forth in Exhibit B are hereby approved, effective pending programming and notice to the OPTN membership.

Questions? Thank you! Theresa Daly, Committee Chair thd9003@nyp.org Susan Tlusty, Committee Liaison susan.tlusty@unos.org