1. Operations and Safety Committee Spring 2014
Proposal to Modify ABO Determination, Reporting, and Verification Requirements
Operations and Safety Committee
Spring 2014

2. 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
OPTN requirements to prevent accidental ABO incompatible transplants have evolved over the years. These events are rare, but the consequences are severe and devastating.
Our system contains robust checks and balances in UNet and policy, yet we have identified areas where safety gaps and risks present an opportunity to make improvements.
We have also heard from the transplant community that ABO policy can be complex and sometimes confusing. OPTN policies sometimes differ across donation types and between candidates and donors. They do not always align with CMS.
Both the OPTN and CMS have identified ABO verification as an issue for policy compliance.

3. Goal of the Proposal
Reduce risk of accidental ABO incompatible transplants
Increase transplant safety
Improve policy consistency and clarity
Align requirements
This proposal seeks to further reduce accidental ABO incompatible transplant risk, address gaps, and strengthen checks and balances to improve safety.
Our goal is to make policy clearer, more consistent, and align language and requirements where possible within OPTN policy and with CMS.

4. How the Proposal will Achieve its Goal
Area
Proposed Policy
Definitions
Add definition of source document
ABO Determination
Require both deceased donor blood type determinations be completed and reported prior to match run
Align language between donation types and donor/candidate where possible
ABO Reporting
Reports done by a “qualified health care professional”
Match Run
Change “may” to “must” rerun match when organ not allocated on initial match run and transplant hospital updates data/notifies host OPO
This proposal impacts multiple policy sections. I will briefly discuss the highlights. Please see your public comment document for the full details.
Definitions:
A definition for “source document” will be added. Source documents are required to be used when reporting ABO blood type, however, current policy does not contain a definition.
ABO Determination:
Currently the match can be run on one ABO blood type determination with the second one completed prior to incision. In this proposal, both blood type determinations will need to be completed and reported prior to the match run to reduce risk of basing the match on one erroneous result. There is, however, an exception clause for accelerated recoveries to allow completion prior to organ release.
Other changes in both blood type determination and reporting sections will make language and format more consistent between donors and candidates and donation types. Bulleted lists are used where possible.
ABO Reporting:
A “qualified health care professional” will need to report blood type to the OPTN. OPOs and transplant hospitals will define “qualified” within their individual program-specific protocol. Currently there are no requirements and this will help assure some level of training to help reduce reporting errors.
Match Run:
Each year approximately 60 organs are allocated but not from a match run. To increase transplants done with the benefit of an ABO safety check on the match run, policy would change from the current statement that OPOs “may” to OPOs “must” rerun the match when organs are not accepted on an initial match and the transplant hospital updates candidate data and notifies the host OPO.

5. How the Proposal will Achieve its Goal
Area
Proposed Policy
ABO
Verification
Verifications done by a “qualified health care professional”
Specify information to be verified and acceptable sources
Deceased donor organ recovery verification OPO responsibility-all cases
Living donor organ recovery verification done prior to anesthesia-all cases
Organ check-in when arriving from other OR suite
Pre-procedure verification when surgery starts prior to organ arrival
Final verification includes transplanting surgeon with organ and intended recipient present in OR
Labeling
ABO type can be on blood specimen label accompanying organ
ABO Verification:
Policy sections that cover blood type compatibility verification and time outs will be in one location. Verification must be done by a qualified health care professional as defined in the individual program’s protocol.
Proposed policy lists specific information to be verified, how it can be verified, and what are acceptable sources to use for verification. The proposed language allows use of bar code scanning in anticipation of the Electronic Tracking and Transport project application under development.
OPOs are given responsibility to conduct deceased donor organ recovery verification in conjunction with the on-site surgical recovery team prior to organ release. Current policy places the responsibility with the transplant hospital or host OPO. This proposed change better aligns with CMS regulations. CMS removed the requirement for transplant hospitals to conduct verification prior to deceased donor organ recovery but kept the requirement for the OPO. The proposed change would apply to all deceased donor recoveries not just those required when organs remain in the same operating room suite in current OPTN policy.
On the living donor side, recovery hospitals would need to conduct a verification prior to donor anesthesia. This is proposed as safer timing –currently it is required prior to leaving the donor OR. This would more closely align with CMS which requires verification be done before removal of the donor’s organ. The proposed change would apply to all recoveries, not just those for those organs that remain within the same facility in current policy.
An organ check-in is proposed for deceased and living donor organs arriving from a different recovery operating suite to assure that the organ received is the expected one for the correct recipient. This check in can be combined with the final pre-transplant verification when the organ immediately goes into the OR without a break in chain of custody.
When surgery starts prior to organ arrival, an additional pre-procedure verification is proposed prior to anesthesia. This is a patient safety measure and consistent with Joint Commission requirements.
Final pre-transplant verification language would be more specific than current policy. The transplanting surgeon would be required to participate; this is consistent with CMS. Current OPTN policy references only the transplant hospital. Proposed language specifies that the final pre-transplant verification take place in the OR with the organ and recipient present between the time of organ delivery into the OR and before first anastomosis. This seeks to address common questions and compliance issues.
Labeling:
Current policy prohibits the ABO type from being on the label of blood specimens sent with organs. Proposed language would allow ABO type to be on the label. This addresses a policy rewrite parking lot issue and will assist with streamlining ETT development and process.

6. How the Proposal will Achieve its Goal
Area
Proposed Programming
Liver ABOi Registrations
Add warning
Match Run
Add candidate blood type on view and highlight ABO compatibility status
The Committee is proposing two UNet enhancements that are independent of policy language changes.
The first would add a warning when registering liver candidates willing to accept ABO incompatible organs. Only one person is needed to make this listing and there are no current checks and balances such as titer requirements in pediatric heart listings.
The second enhancement would display all candidate blood types on the match run. Compatibility will be graphically clear. ABO incompatible matches allowed by policy (including those that are subtype dependent such as blood type O and A, non-A1) would have a warning type symbol such as a red exclamation mark. This enhancement may also be used to help with verification purposes.

7. Additional Background
Failure Modes and Effects Analysis (FMEA):
Policy recommendations
Competency training and education
Electronic solutions: UNet and Electronic Tracking and Transport Project
Further aligns some requirements with CMS:
OPO deceased donor organ recovery verification
Living donor organ recovery verification scope and timing
Transplant surgeon in final pre-transplant verification
The Committee work group started formally in 2012 and had representatives from the Transplant Administrators and Coordinators Committees. The group conducted a Failure Modes and Effects Analysis (FMEA) with assistance from patient safety consultants. Over 60 potential fail points were identified and prioritized. The Committee developed recommendations to reduce identified risks for the top 11 fail points.
Our Committee wants to stress that this policy proposal covers some but not all strategies planned to improve ABO safety. Future work based on FMEA recommendations includes developing competency training, providing more educational materials, as well as considering a separate ABO tab and collaborating with the ETT (Electronic Tracking and Transport Project) to improve labeling and verification tools.
This proposal will better align some OPTN requirements with CMS, including OPO responsibility for deceased donor organ recovery. It will move up the timing of the living donor organ recovery verification to be safer and more consistent with CMS. Having the transplanting surgeon be part of the final pre-transplant verification will be consistent with CMS as well.

8. Supporting Evidence Failure Modes and Effects Analysis (FMEA)
Data analysis:
ABO policy compliance
Cases not on match run
Changes to ABO listings
Patient safety situation reporting
Literature Review
The FMEA included a comprehensive examination of all ABO processes currently conducted and was used to identify the most concerning areas of risk.
Several data analyses were used to guide recommendations such including ABO policy compliance, analysis of transplants not on the match run, changes to ABO blood type reports, patient safety situation reports, and an overall literature review.

9. What Members will Need to Do
OPOs and Transplant Hospitals will need to:
Define “qualified health care professional” in protocols
Be familiar with required verification information and acceptable sources
OPOs will need to:
Assure two blood type determination and reports completed prior to match run
Conduct deceased donor organ recovery verification
Rerun match if organ not allocated on initial run if data are updated/reported
OPOs and Transplant Hospitals will need to familiarize themselves with changes in policy. This would include defining a “qualified health care professional” in their protocols and being familiar with the list of required verification information and what sources can be used.
OPOs will need to assure that two ABO blood type determination and reports are completed prior to the match run, which may require changes from current process, and be responsible for conducting deceased donor organ recovery verification in conjunction with the on-site surgical recovery team. The match run will need to be rerun in cases where the organ is not allocated on the first match run and a transplant hospital updates candidate data and notifies the host OPO.

10. What Members will Need to Do
Transplant hospitals will need to:
Conduct living donor organ recovery verification prior to anesthesia
Conduct organ check in when organs arrive from different OR suite
Conduct pre-procedure verification when surgery starts prior to organ arrival
Transplant hospitals will need to conduct living donor organ recovery verification prior to anesthesia, conduct organ check in when organs arrive from a different OR suite, and conduct additional pre-procedure verification when surgery starts prior to organ arrival in addition to the final pre-transplant verification.

11. Questions? Jean Davis Committee Chair jean.davis@lifelinkfound.org
Name Region # Representative
Susan Tlusty Committee Liaison