1. 1 Improving Post-Transplant Communication of New Donor Information Ad Hoc Disease Transmission Advisory Committee Spring 2016

2. 2 What problem will the proposal solve?  Communication delays or failures about new donor information learned post-transplant have led to transplant recipient morbidity and mortality  Policy requirement: must report PDDTE to patient safety contact and OPTN Improving Patient Safety Portal (IPS)  General policy language allows reporting to vary  Over and under reporting exist  Process doesn’t always function as intended

3.  Provide more specific reporting guidelines  What types of results  Who needs to receive report  When do they need to receive it  More standardized and efficient communication  Devote resources and attention to most critical results What is the goal of the proposal? 3

4. Type of ResultsWho Reports Where ReportedTime Frame All results (including negatives) OPOUpload to DonorNet Pathogens of Special Interest Malignancy or other findings highly suggestive of malignancy recognized after procurement OPORecipient(s) Transplant Program Patient Safety Contact (PSC) OPTN Improving Patient Safety Portal (IPS) ASAP but no later than 24 hours after receipt How does the proposal address the problem statement? 4

5. OPOs must report the following positive results: 5 Report ONLY to the receiving transplant program patient safety contact ASAP but no later than 24 hours after receipt  Serologic, NAT, or antigen results indicating presence of parasites, virus, or fungi  Cultures from the following specimens:  Ascites  Blood  Cerebrospinal fluid (CSF)  Deep wound  Pericardial  Pleural fluid  Tissue  Mycobacterial smears and cultures  Fungal smears and cultures with the exception of Candida species 1  Respiratory samples only to transplant programs receiving lungs* 1 Candida from sterile sites needs to be reported within 24 hours

6. OPOs must report the following positive results: 6 Report ONLY to the receiving transplant program patient safety contact ASAP but no later than 24 hours after receipt  Urine cultures only to transplant programs receiving kidneys*  Any histopathology results (including negative results) reported post-procurement  All final culture information for any culture results that were reported according to these requirements  Other psycho-social history, medical history, autopsy, testing, and laboratory findings identifying infectious conditions that may adversely affect a potential transplant recipient *Mycobacterial and fungal (with the exception of Candida species) positive results must be reported to the transplant program’s recipient of any organ

7. Type of ResultsWho Reports Where Reported Time Frame All toxoplasmosis results for donor testing conducted by transplant program (includes negatives) Tx Program Host OPOs Risk of potential transmission of disease or malignancy discovered in living donor Living donor recovery hospital Receiving transplant program PSC OPTN IPS ASAP but no more than seven days after receipt of the new information How does the proposal address the problem statement? 7

8.  Failure Modes and Effects Analysis (FMEA) conducted on Post Transplant Results Communication  8 process steps: 28 potential failure modes  17 recommendations on 16 highest failure modes  Proposal addresses six of the recommendations Supporting Evidence 8

9. Supporting Evidence: Communication Gaps Impact Infectious Disease Transmissions What Contributed?  Transplant center delayed contacting the OPO with a suspected donor derived infection  Failure of labs to relay donor results to the OPO and/or transplant center  OPO delay in contacting DTAC or transplant centers  Clerical errors  Test results communicated by OPO to transplant centers was incomplete What happened?  18 of 56 (32%) infectious events (IE) had communication gap or delay  12 of 18 (67%) IE had adverse event  20 out of 29 recipients experienced adverse event  6 deaths R Miller et al, “Communication Gaps Associated with Donor-Derived Infections,” American Journal of Transplantation 15 (2015): 259-264.

10. Supporting Evidence: Percent of Deceased Donors Recovered 2013-2014 with Case Reported and Proven/Probable Case through 8/21/2015 by Region of Recovery 10

11.  OPOs and transplant hospitals need to familiarize staff responsible for PDDTE reporting with the new policy  OPOs need to develop a reporting protocol that includes:  Obtaining all results for any deceased donor testing conducted  Uploading all deceased donor testing results to DonorNet  Sharing relevant deceased donor test results with tissue banks  Reporting specified positive test results to the transplant hospital patient safety contact (as soon as possible but no later than 24 hours of receipt)  Reporting specified positive test results to the OPTN (as soon as possible but no later than 24 hours of receipt) How will members implement this proposal? 11

12.  Transplant hospitals need to:  Report to the host OPO all toxoplasmosis results (including negative results) conducted on deceased donor samples  Continue to report suspected cases of donor-derived transmissions  Living donor recovery hospitals need to:  Report all risk of potential transmission of disease or malignancy as soon as possible but no more than seven days after receipt of the new information  Continue to report suspected cases of donor-derived transmissions How will members implement this proposal? 12

13.  Promote living donor and transplant recipient safety: This proposal will :  1. Clarify expectations regarding how OPOs report new donor information learned post-transplant  2. Triage direction on how this information is shared to reduce:  Burdens of both sharing and receiving  Perceived desensitization within the community due to the "noise" currently flooding the current reporting system and allow more focus on critical results How does this proposal support the OPTN Strategic Plan? 13

14.  Many results will not require urgent communication  Routine urine cultures (non-kidney recipient center)  Routine sputum cultures (non-lung recipient center)  Focus on recipient disease rather than donor cultures in reporting to the OPTN  Exception for pathogens where CDC investigation may be able to assist transplant centers  Sharing toxoplasmosis results with all recipient centers  Difficulties with communicating and performing donor testing when done at heart center  Recent recognition that these results are relevant to non-heart recipients Summary 14

15.  What are both the OPO and transplant hospital experiences in this region with toxoplasmosis testing?  DTAC is considering requiring all OPOs to conduct toxoplasmosis testing to:  Overcome logistical challenges for transplant hospitals to complete the testing  Assure that disease in non-cardiac recipients is not missed  Seeking VCA specific feedback Feedback needed 15

16. Daniel Kaul MD Committee Chair kauld@med.umich.edu Susan Tlusty Committee Liaison susan.tlusty@unos.org Questions? 16

17. Extra Slides 17

18.  FMEA conducted on Post Transplant Results Communication Supporting Evidence 18 Process Step/ Failure Mode Priority Recommended Action(s) Score Rank 1d. OPO does not get all of the valid information 44811 ●OPOs must develop a protocol for tracking and collecting all pending results ●OPOs must post information to DonorNet for transplant center review ●Conduct review of best practices and disseminate 1e. OPO does not follow up on all labs (e.g. pending cultures) 46410●See 1d above 2a. Incomplete information is reported 44811●Develop decision support tool to triage information reporting ●Ensure staff making decisions to send information have adequate expertise and training. ●Post negatives to DonorNet and then call positives using “on call” features within DonorNet. Features allow for email or text rather than phone.

19.  FMEA conducted on Post Transplant Results Communication Supporting Evidence 19 Process Step/ Failure Mode Priority Recommended Action(s) Score Rank 2b. OPO fails to appropriately identify information to report to patient safety contact 29619●See 2a above 4a. Delay in information reaching patient safety contact 5763●Require OPOs to have a protocol 4b. Failure to confirm information transfer 43215●See 4a above 7b. Failure to report potential donor-derived disease transmission event (PDDTE) from transplant hospital 5044●Ongoing educational effort to optimize reporting and minimize burden to members (reducing potential over reporting) (Note: Will be done as part of policy implementation)

20. Supporting Evidence: Historical Trends of PDDTE Reporting to the OPTN 20 20152014201320122011 Reports made to OPTN406458391235217 Reports chosen for DTAC review289278284198181 Reports not reviewed1171801073736 % Reviewed71.2%60.7%72.6%84.3%83.4% Donors transmitting proven/probableN/A35323331 Intervention without documented transmission (IWDT)N/A63732334 Unlikely/ExcludedN/A16615212898 PossibleN/A14271418 Donors transmitting proven/probableN/A12.6%11.3%16.7%17.1% IWDTN/A22.7%25.7%11.6%18.8% Unlikely/ExcludedN/A59.7%53.5%64.6%54.1% PossibleN/A5.0%9.5%7.1%9.9%