1. Operations and Safety Committee
Spring 2014

2. Ongoing Committee Initiatives
Sharing patient safety data/lessons learned
Analyzing patient safety situation data reports
Working with MPSC to receive routine referrals on safety topics
Educate members through:
Patient Safety Alert
Patient Safety News
Regional meeting updates
Instructional events
The Operations and Safety Committee continues to work on its project to share patient safety situation data and lessons learned.
Every six months the Committee reviews aggregate safety situation reports to look for trends and areas where safety messaging could help members. Highlights from the analysis are published in the Patient Safety News with a link to the report on Transplant Pro. Starting in March, the MPSC will begin routinely referring relevant safety situation topics to our Committee. The Committee’s Patient Safety Advisory Group will evaluate topics and work to develop appropriate educational strategies using safety alerts, patient safety news articles, regional meeting updates, and instructional events.

3. Ongoing Committee Initiatives
Electronic Tracking and Transport Project (ETT)
Complete field testing
Application development
Beta testing
BOD Presentation
Mar 2014
May 2014
Sept 2014
Nov 2014
Work continues on the Electronic Tracking and Transport (ETT) project. Field testing started in Summer 2013 and will finish up in March. Five OPOs who were part of the pilot project participated in. These include LifeNet Health (VA), Life Source (MN), California Transplant Donor Network (CA), LifeLink Foundation (GA), and the Living Legacy Foundation (MD). The application uses a tablet and printer to produce human readable and barcode labels. Over 250 organs have been recovered using the ETT in field testing. After each case, OPOs used a survey tool to give feedback to ETT project staff.
A vendor is being selected to develop Version 4.0. This latest version of the ETT application will incorporate needed improvements that were identified through field testing. The goal is to have this version ready for beta testing in August 2014.
The five OPOs that participated in field testing along with three additional OPOs to be selected will receive train-the-trainer sessions in August.
These trainings will include transplant hospital staff. Beta testing will start in September. The committee will present its progress at the November Board of Directors meeting and request direction for next steps.

4. Living Donor Evaluation Safety
Overlooked test result may lead to:
preventable disease transmission
near-miss disease transmission
Specifies required tests, evaluations, exclusions
Does not address process of reviewing results/determining approvals
HIV, HBV, and HCV testing “as close as possible to the date of the donor operation, but at least within the 28-day time period prior to surgery.”
Issue
Policy
PHS Guideline
As part of our collaboration with UNOS Staff and the MPSC, we want to discuss safety and living donor evaluation today.
The OPTN contractor has been alerted of several instances in which Living Donor Recovery Hospitals inadvertently missed reviewing a clinical element required by policy, such as serological testing results, and experienced a preventable disease transmission or a near-miss of a potential disease transmission. 
During the medical evaluation of living donors, it is possible for programs to overlook the results of a required screening test, or other evaluation requirement, or exclusionary element that can lead to significant and potentially harmful consequences for both the donor and the recipient.  
Current OPTN Living Donor Policy 14.4 specifies requirements for medical evaluations. Section 14.4.A requires that blood typing of each living donor be performed on two separate occasions before the recovery.  Policy 14.4.B specifies requirements for living kidney donors and provides detailed lists for testing, evaluation, and exclusions including: infectious disease testing requirements and exclusionary criteria. Policy 14.4.C addresses living liver donors.
The recently released 2013 PHS Guideline for Reducing HIV, HBV, and HCV Transmission Through Organ Transplantation recommends that all living donors are tested for HIV, HBV, and HCV “as close as possible to the date of the donor operation, but at least within the 28-day time period prior to surgery.”
As you will hear today, several public comment proposals would further modify OPTN policy requirements. Current policy does not specify how close to donation testing must occur, the process by which required elements must be reviewed, or the process by which a program determines final approval for donation.  Transplant programs across the country have devised different processes to evaluate donor suitability.
To minimize human error and the potential for patient harm, Living Donor Recovery Hospitals should establish processes to ensure that donors’ evaluations are thorough, complete, well-documented, meet current OPTN requirements and are reviewed at key points in time prior to the surgery. 

5. Suggestions to minimize risk: Living Donor Evaluation
Create living donor evaluation checklist
Develop selection comm. evaluationprocedure
Implement “final” review before surgery date
Add serologies to hard-stop on surgery day
Conduct double verification when reviewing labs
Document, document, document!
Living Donor Recovery Hospitals should ensure that a final review has occurred before donation and that all required testing and follow-up have been addressed.  Here are some examples of practices that, while not required, may assist Living Donor Recovery Hospitals to ensure that the evaluation of each donor is thorough, consistent, and documented appropriately:
1.) Create a Living Donor Evaluation checklist that is completed before surgery that ensures that all required elements have been completed and the exclusionary criteria have been adequately addressed.
2.) Develop a Selection Committee procedure to evaluate all potential living donors. 
specify which staff are required to determine a denial or final approval of a donor’s suitability.
identify a point-person to ensure that all of the critical data elements have been addressed prior to proceeding to the operating room. 
ensure that meeting minutes are accurately documented.   
include a plan to reevaluate and ensure that follow-up items identified during a donor’s evaluation have been addressed.
3.) Because the evaluation of a living donor often occurs over several months, consider implementing a “final” review of all donor/recipient information close to the scheduled donation date.  This will confirm that all required testing has been completed and results have been reviewed. 
4.) Along with the ABO verification, Living Donor Recovery Hospitals can add serologies and any other critical data elements to the hard-stop verification that occurs on the day of surgery.   
5.) Hospitals can also implement a double-verification process when entering critical lab values into UNetSM or during a review of uploaded labs.
6.) Finally, document, document, document.  Living Donor Recovery Hospitals should ensure that the decisions and rationale for approval are clearly and thoroughly documented in the donor’s medical record. 

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