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

§  UNetsm 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 (TransNetsm)

implementation

§  Concerns about clarity of policy

General Public Comment Themes

Requirement Current Proposed Align 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-in None If organ arrives from different OR suite

no rule

Pre-procedure ABO verification

None If 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

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    Ac7ve  OPTN    Wait  List    

Medical  eval  prior  to  dona7on  

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  

AHer  organ  arrival,  prior  to  transplant  

All:  Before  removal  

donor  organ  

AHer  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 thd9003@nyp.org §  Regional Rep Name

Region X Representative email address

§  Susan Tlusty

Committee Liaison susan.tlusty@unos.org

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

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)

Top Failure Modes