Elizabeth Friddell
Site SurveyorUNOSThe Alliance
Insight Series
The Alliance insight series offers critical resources for stakeholders across the donation and transplantation continuum. For each topic, you can find related action items, tools, and references.
ISSUE 2
The Alliance Insight Series
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A Note About Content
Some legacy resources on this website may refer to UNOS in place of the OPTN, reflecting common usage at the time of publication when the two were often used interchangeably. In recent years, significant work has gone into distinguishing these as separate entities: the OPTN is the nationwide organ transplant network established by federal law, while UNOS is one of several organizations currently under contract to support OPTN operations. We’ve preserved these resources as originally published, but recommend referring to current terminology for the most accurate understanding of each organization’s role.
SEPTEMBER 2024 | ISSUE 1
Background
In March 2021, the OPTN aligned its policies with the U.S. 2020 Public Health Service (PHS) Guideline for assessing solid organ donors and monitoring transplant recipients for HIV, HBV, and HCV infection, as required by the Final Rule.
Education
| POLICY INTERPRETATION | OPTN POLICY 15.2: CANDIDATE PRE-TRANSPLANT TESTING REQUIREMENTS | |||
|---|---|---|---|
| WHAT | WHEN | EXCEPTIONS | CONSIDERATIONS |
Unless testing would violate state or federal laws, all transplant candidates must be tested for:
| For candidates 12 years or older, blood samples must be collected during the hospital transplant admission prior to anastomosis of the first organ. | If candidate is known to be infected with HIV, HBV, or HCV, then testing for the known viral infection(s) is not required. |
|
| For candidates less than 12 years old on the date of transplant, blood samples can be collected/tested any time before transplant, and does not need to be repeated prior to transplant. | |||
| HIV: Human immunodeficiency virus; HBV: Hepatitis B Virus; HCV: Hepatitis C Virus; NAT: nucleic acid test; RNA: ribonucleic acid | |||
| POLICY INTERPRETATION | OPTN POLICY 15.3.C: REQUIRED POST-TRANSPLANT INFECTIOUS DISEASE TESTING | ||
|---|---|---|
| WHAT | WHEN | CONSIDERATIONS |
Transplant programs must test all recipients post-transplant for:
| Blood sample must be collected for all transplant recipients at least 28 days, but no later than 56 days post-transplant. |
|
Transplant programs must test all liver recipients for:
| Blood sample must be collected for liver recipients at least 335 days but no later than 395 days post-transplant. | |
Action
1. Improving Compliance Through Changes in Work Flow Processes
a. Create order sets for pre-transplant testing placed by inpatient transplant team at time of transplant admission
- Pre-check/select labs on admission order sets
- Create lab panel (i.e., Pre-Transplant PHS Labs) that is “locked-down” to ensure that all testing is completed, and end-users are not able to delete any required testing.
b. Opportunities to improve post-transplant testing compliance
- Order Sets: As part of the discharge process, transplant clinician places the post-transplant PHS testing order.
- Create notification process: If the patient is still inpatient during post-transplant testing period. Communication with your inpatient team is key.
- III. Scheduling: Post-transplant team will schedule the patient’s follow-up clinic visits, and one visit to correspond to the closest weekday that is at least 28 and no more than 56 days post-transplant.
2. Improving Compliance Through Monitoring
a. Leverage Epic EMR: Create checklist task to monitor testing completion
- Post-transplant Coordinator to create checklist task as soon as the transplant notification is received.
- The testing order can be linked to the checklist task for auto completion of the task.
b. Create an automated tracking report- can be utilized by coordinators as part of standard work to monitor completion of ordered labs.
C. Creation of a dashboard to monitor compliance by post-transplant team and quality team
- Post-transplant Coordinator to create checklist task as soon as the transplant notification is received.
- Start and end date of testing window and number of days left in testing window are shown.
- Color coding is utilized to mark patients compliant w/ testing requirements (green), within the testing window but testing not complete (yellow), and patients coming into the testing window (gray).
- This report can be filtered by transplant organ, transplant coordinator.
3. Compliance is a team effort: Dissemination to transplant teams
- Maintaining a regular audit schedule that is conducted by the quality team and results are sent out to the transplant center.
- Identified noncompliance and policy education is sent to nurse managers to review with organ specific teams.
Lessons Learning on the Journey Toward Compliance
1. Collaboration and education of all multidisciplinary team members is key
- Several transplant programs have developed “double-checks” throughout the pre-transplant admission process to ensure labs are collected. Some strategies for consideration:
- Fast tracking samples to lab to allow enough time for reminder for collection /re-collection if needed
- Use EMR reports to ensure that all ordered labs have been collected/resulted. If blood sample isn’t collected/resulted, coordinate with lab to have labs re-run on extra blood samples from patient collected prior to transplant.
- Real-time follow up and education with the team when noncompliance is noted, including any residents, fellows, bedside nurse, etc., depending on the circumstance.
- Some laboratories and payors have testing algorithms and timeframes that prohibit collection and/or coverage for specific tests. These cases may require additional follow-up and education to ensure all testing has been completed.
- TIEDI Reporting Requirements
| REPORTING PRE- AND POST-TRANSPLANT PHS LABS IN TIEDI | |||
|---|---|---|---|
| TIEDI FORM | WHAT TO REPORT | WHERE TO REPORT | CONSIDERATIONS |
| Transplant Recipient Registration (TRR) | Pre-Transplant Testing for All Recipients | Viral Detection:
NAT Results:
| Enter all available pre-transplant testing results. Not all testing on the TRR is required per OPTN policy. If testing is not completed, put NOT DONE. |
| Transplant Recipient Follow-Up (TRF) 6 Month Form | Post-Transplant Testing (28-56 Days) for All Recipients | Viral Detection:
For all recipients, documentation on 6-month TRF should be completed if lab results were within the 28-56 days post-transplant range. Unlike the TRRs, if testing was outside this range or not completed, select NOT DONE. | For results that are originally equivocal (or indeterminate):
|
| Transplant Recipient Follow-Up (TRF) 1 Year Form | Post-Transplant Testing (335-395 Days) for Liver Transplant Recipients | Viral Detection:
If testing of highlighted field is not completed within the 335-395 days post-transplant testing window, select NOT DONE. | |
Additional Resources
How to access risk adjustment factors from the SRTR public website:
- Go to public SRTR website (www.srtr.org)
- Tools ⇨ Risk Adjustment Models ⇨ Waiting List ⇨ Pre-transplant Mortality Rate (previously labeled waitlist mortality rate)
- Choose organ of interest and age group ⇨ click on “Model Coefficients” tab and then download .csv file. This will show you which factors are risk adjusted for the candidate, as well as the impact of each factor.
How to see reported pre-transplant mortality programmatic information on SRTR secure website:
- Go to secure SRTR site (https://securesrtr.transplant.hrsa.gov/home/)
- Reports ⇨ either Current Release or Archives ⇨ Program
- Download Waitlist Expected Worksheet
OPTN Survey Readiness
1. Pre-Transplant Testing: Provide documentation that shows required testing was completed after transplant admission & prior to anastomosis of first organ. Documentation Requirements:
- Admission Date and Time
- Anastomosis time
- Lab Results, including collection time
2. Post-Transplant Testing: Provide documentation that testing was completed within 28-56 days post-transplant for all recipients and 335-395 days post-transplant for liver recipients.
Tools & Resources
- OPTN policies to align with 2020 U.S. Public Health Service Guideline – Toolkit
- CDC PHS Guideline
- CDC Guidelines for Organ Transplants
- OPTN Policies and Evaluation Plan
- Notice of OPTN Policy Changes
- PHS – FAQs
- Lab testing FAQs
- UNOS Connect: search for the PHS Playlist
- CDC Vaccination Schedule 2024
- Hepatitis B Foundation – Vaccination Schedule and Guidelines
A SPECIAL THANKS TO THIS ISSUE’S CONTRIBUTORS
We would like to express our sincerest gratitude for our contributors’ tireless efforts on making Transplant Quality Corner a reality. Their dedication and expertise have been an invaluable contribution to the successful launch of this project. We are incredibly grateful for all their hard work and commitment.
Tamika Watkins
Disease Transmission Advisory CommitteeUNOSA SPECIAL THANKS TO THE TRANSPLANT QUALITY CORNER WORKGROUP
Denisia Chen
RN, CHC, CPCTransplant Regulatory Compliance SpecialistStanford Medicine Children's Health
Abbey Olsen
MSN, RN, CCRNTransplant Quality ManagerUniversity of Utah Hospital
Deepa Kurup
RN, MSN/MBA, LSSBB, CPHQSenior Director, Center for TransplantationUC San Diego Health System
Melissa Robinson
Quality & Safety Director, Transplant Institute Loma Linda University Medical Center
Jenna Lawson
MSProgram Director, Pediatric TransplantVanderbilt University Medical Center
Hellen Oduor
Quality DirectorMethodist Dallas Medical Center
Lindsay Smith
RN, MSNTransplant Quality DirectorVanderbilt University Medical CenterFEEDBACK
If there is content you feel that should be added or was lacking, we would like to hear from you. Positive feedback on what is working for you, is also welcomed. Thank you for taking the time to provide us with your feedback.