Transcript DTAC - Transplant Pro

Improving Post-Transplant
Communication of New Donor
Information
Ad Hoc Disease Transmission Advisory Committee
Spring 2016
1
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
2
What is the goal of the proposal?

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
3
How does the proposal address the problem
statement?
Type of Results
• All results (including
negatives)
• Pathogens of Special
Interest
• Malignancy or other
findings highly suggestive
of malignancy recognized
after procurement
Who
Where Reported
Reports
OPO
Upload to DonorNet
OPO
• Recipient(s) Transplant
Program Patient Safety
Contact (PSC)
• OPTN Improving Patient
Safety Portal (IPS)
Time
Frame
ASAP but
no later
than 24
hours after
receipt
4
OPOs must report the following positive results:
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:  Deep wound
 Ascites
 Pericardial
 Blood
 Pleural fluid
 Cerebrospinal fluid (CSF)
 Tissue
 Mycobacterial smears and cultures
 Fungal smears and cultures with the exception of Candida species1
 Respiratory samples only to transplant programs receiving lungs*
1
Candida from sterile sites needs to be reported within 24 hours
5
OPOs must report the following positive results:
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
6
How does the proposal address the problem
statement?
Type of Results
All toxoplasmosis results for donor
testing conducted by transplant program
(includes negatives)
Risk of potential transmission of disease
or malignancy discovered in living donor
Who
Reports
Tx
Program
Where
Reported
Host OPOs
Time Frame
Living
donor
recovery
hospital
• Receiving
transplant
program
PSC
• OPTN IPS
ASAP but no
more than
seven days
after receipt
of the new
information
7
Supporting Evidence

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
8
Supporting Evidence: Communication Gaps
Impact Infectious Disease Transmissions
What happened?
What Contributed?

18 of 56 (32%) infectious events
(IE) had communication gap or
delay

Transplant center delayed contacting
the OPO with a suspected donor
derived infection

12 of 18 (67%) IE had adverse
event

Failure of labs to relay donor results to
the OPO and/or transplant center

20 out of 29 recipients
experienced adverse event

OPO delay in contacting DTAC or
transplant centers

6 deaths

Clerical errors

Test results communicated by OPO to
transplant centers was incomplete
R Miller et al, “Communication Gaps Associated with Donor-Derived Infections,” American Journal of Transplantation 15 (2015): 259-264.
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
How will members implement this proposal?

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)
11
How will members implement this proposal?


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
12
How does this proposal support the OPTN
Strategic Plan?

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
13
Summary

Many results will not require urgent communication



Focus on recipient disease rather than donor cultures in reporting to
the OPTN


Routine urine cultures (non-kidney recipient center)
Routine sputum cultures (non-lung recipient center)
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
14
Feedback needed

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
15
Questions?
Daniel Kaul MD
Committee Chair
[email protected]
Susan Tlusty
Committee Liaison
[email protected]
16
Extra Slides
17
Supporting Evidence

FMEA conducted on Post Transplant Results Communication
Process Step/ Failure Mode
Priority
Recommended Action(s)
Score Rank
1d. OPO does not get all of the valid 448
11
● OPOs must develop a protocol for tracking and
information
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
464
10
● See 1d above
labs (e.g. pending cultures)
2a. Incomplete information is
448
11
● Develop decision support tool to triage information
reported
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.
18
Supporting Evidence

FMEA conducted on Post Transplant Results Communication
Process Step/ Failure Mode
Priority
Recommended Action(s)
Score Rank
2b. OPO fails to appropriately identify 296
19
● See 2a above
information to report to patient safety
contact
4a. Delay in information reaching
576
3
● Require OPOs to have a protocol
patient safety contact
4b. Failure to confirm information
432
15
● See 4a above
transfer
504
4
● Ongoing educational effort to optimize reporting and
7b. Failure to
minimize burden to members (reducing potential over
report potential donor-derived
reporting) (Note: Will be done as part of policy
disease transmission event (PDDTE)
implementation)
from transplant hospital
19
Supporting Evidence:
Historical Trends of PDDTE Reporting to the OPTN
Reports made to OPTN
Reports chosen for DTAC review
Reports not reviewed
% Reviewed
2015
406
289
117
71.2%
2014
458
278
180
60.7%
2013
391
284
107
72.6%
2012
235
198
37
84.3%
2011
217
181
36
83.4%
Donors transmitting proven/probable
Intervention without documented transmission (IWDT)
Unlikely/Excluded
Possible
N/A
N/A
N/A
N/A
35
63
166
14
32
73
152
27
33
23
128
14
31
34
98
18
Donors transmitting proven/probable
IWDT
Unlikely/Excluded
Possible
N/A
N/A
N/A
N/A
12.6%
22.7%
59.7%
5.0%
11.3%
25.7%
53.5%
9.5%
16.7%
11.6%
64.6%
7.1%
17.1%
18.8%
54.1%
9.9%
20