(OSC) – ABO determination

Report
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
Total Overall
Implementation
Hours
2,240/17,885
750
0
0
1000
2000
3000
4000
5000
2240
2000
4000
6000
Public Comment Feedback
Public Comment Response Tally
Type of
Response
No Vote/
In Favor
No
Response
as
In Favor
Opposed Comment/
Total
Amended
Did Not
Consider
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
ABO Testing issues: 9
Communication issues: 8
Near
Misses
1/20126/2014
Labeling errors: 63
Changes to ABO data: 329
2009-2012
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
Rank
Number
Failure Mode
1
1
2
1
2
3
2
4
2
5
3
3
6
7
4
4
8
9
5
5
10
11
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)
Proces
s Step
6
8
2
8
8
1
8
1
4
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


Require protocol to have process when ABO
primary types do not match


Post public comment to align with CMS
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
OPTN
CMS
Before
organ
recovery
Medical
eval prior to
donation
Deceased
Donor
Prior to
Match Run
Prior to
Incision
Living
Donor
Prior to
generate
Donor ID
Before
recovery
Candidate
Prior to
Active OPTN
Wait List
Before on tx
hospital
wait list
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


Includes list of ID elements and acceptable
verification sources


Post public comment for clarity
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:
Donor ID

Organ (and laterality if applicable)


External and internal organ package
labels
Documentation with organ
Organ received
Donor blood type and subtype
(if used for allocation)

Donor blood type and subtype source
documents
Recipient unique identifier

Recipient identification band
Recipient blood type

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

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
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
Deceased
Donor
After organ
arrival, prior
to transplant
Substantive ABO Policy Changes
Requirement
Timing
Changes
Current
Proposed
Align
with
CMS
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

incision
Living donor recovery
verification must be
conducted
Prior to leaving
OR
Prior to general
anesthesia for donor

incision
Current
Deceased donor pre
Practice
recovery verification (time
Expanded to out) must be conducted
All Cases
Living donor recovery
verification (time out) must
be conducted
If organs remain in All cases
same OR suite
New
Organ check-in
Conditional
Actions
Pre-procedure ABO
verification
None
If organ arrives from
different OR suite
no rule
None
If recipient surgery
starts prior to organ
receipt
no rule
If organs remain in All cases
same OR facility
Eliminates
verification when
leaving donor OR

OPO

Programming
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
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
[email protected]
Susan Tlusty, Committee Liaison
[email protected]

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