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Adverse Occurrence type:
All reported potential donor-derived transmission events are reviewed by the Organ Procurement and Transplantation Network (OPTN) Ad Hoc Disease Transmission Advisory Committee (DTAC). Reports from January 2008 to June 2010 were retrospectively evaluated for communication gaps between the donor center, OPO, and transplant centers. Fifty-six infection events (IEs; involving 168 recipients) were evaluated. Eighteen IEs (48 recipients) were associated with communication gaps, of which 12 resulted in adverse effects in 69% of recipients (20/29), including six deaths. Total number of transplant events (# of organs transplanted, # of recipients) was not reported. For recipients with and without communication gaps, IEs involving bacterial pathogens were the most common (61% and 47%, respectively), followed by fungal pathogens (17% and 32%, respectively), viruses (17% and 13%, respectively) and parasites (6% and 8%, respectively).
Time to detection:
Recipients with donor-derived bacterial infections became symptomatic in the range of 6–43 days after transplant. In five IEs, the transplant center delayed contacting the OPO or the OPTN with a suspected donor-derived infection (range 22–56 days). In four IEs, the laboratory failed to relay donor results (including autopsy results) to the OPO and/or transplant center. Other communication gaps included an OPO delay in contacting the OPTN or transplant centers (three IEs), clerical errors in the reporting donor viral serologies (three IEs), and incomplete communication of test results by the OPO to transplant centers (three IEs). OPTN policy requires information surrounding possible transmission events to be communicated within 24h, however, this report defined a delay in communication as >3 days. This time frame was chosen as the longest reasonable time frame for reporting (based on multiple influences).
Alerting signals, symptoms, evidence of occurrence:
Symptoms related to diagnosis of the infections were not reported.
Demonstration of imputability or root cause:
Included only infection events (IEs) classified as proven, probable, or intervention without documented transmission (IWDT) per standard DTAC case classification. Donor-derived transmission classifications were defined as follows: (1) proven: proven disease in the donor and at least one recipient; (2) probable: disease in one or more recipients with suggestive data that the donor was the source of the disease; (3) IWDT: no transmission occurred due to the administration of antimicrobials to one or more of the recipients. Case classification and recipient outcomes were based on follow-up at 45 days per OPTN policy.
Miller R et al. Am J Transplant. 2015 Jan;15(1):259-64
This is an aggregate report covering over two years. Thus, "Type not specified" was selected for "Infection" and for "Organs". Additionally, although proven, probable, and possible selections would all fit for the "Imputability grade", only probable was selected since only one grade can be selected--> imputability set to "none" (EP)
Expert comments for publication:
When IEs and test results were reported without delay, appropriate interventions were taken, subsequently minimizing or averting recipient infection (23 IEs, 72 recipients). Communication gaps in reported IEs are frequent, occur at multiple levels in the communication process, and contribute to adverse outcomes among affected transplant recipients. Conversely, effective communication minimized or averted infection in transplant recipients.