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

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

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

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

 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

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

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

 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

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

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


“Qualified health care professional” must report
 Safer timing
 Exception clause for accelerated deceased donation cases
 Addresses living donor VCA reporting

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

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

 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

 Organ Check In
 New
 Conditional: When organ received from outside OR suite
 Pre-Transplant Verification
 New
 Conditional: When surgery starts before organ arrives

 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

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

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



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

 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

 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

Near
Misses
Never Event
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

Number Failure 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)