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Frequently asked questions about PDDTE policy changes

General

Effective Date

What is the effective date for these changes?

The policy changes are effective as of September 1, 2016, except for the changes to toxoplasmosis testing and sending a red top tube with the heart. Those changes are effective April 6, 2017.

OPOs

Autopsy

Is it an expectation to upload all donor Autopsy results to DonorNet?

Yes. If the autopsy results contain relevant information that could impact a recipient, then those results must be reported to the receiving transplant hospital’s patient safety contact within 24 hours of receipt of the new information. These results only need to be reported through the Improving Safety Portal as a PDDTE if they indicate malignancy, findings highly suggestive of malignancy, or a “Pathogen of Special Interest”.

Cultures

As an OPO, do I still need to report positive blood cultures?

As of September 1, 2016, OPOs are required to do the following for positive blood cultures:

  1. Post results to DonorNet

  2. Contact all organ recipient transplant hospital patient safety contacts within 24 hours to report the results

  3. Only report the results to the OPTN Improving Patient Safety Portal (IPS) if the results indicate a disease included on the pathogens of special interest list. Routine positive blood cultures do not need to be reported through the IPS they only need to be posted on DonorNet.

As an OPO, what should I do with urine culture results?

OPOs are required to do the following for urine culture results:

  1. Post results to DonorNet

  2. If the results are negative, then posting to DonorNet meets the policy requirements.

  3. If the results are positive, then report positive results (e.g. bacteria or Candida species) to transplant program patient safety contacts that received kidneys or genitourinary VCAs from the donor within 24 hours

  4. Only report the results to the OPTN Improving Patient Safety Portal if the results indicate a disease included on the pathogens of special interest list.

In the section reporting "Positive Results", it reads that "Fungal smears and cultures with the exception of Candida species" must be reported. What should I do in the rare event that blood cultures are positive for Candida?

All positive blood cultures must be reported to the transplant hospital patient safety contact ASAP but no later than 24 hours of receiving the results. Table 15-1: Host OPO Reporting Requirements for Positive Post-Procurement Donor Results and Discovery of Potential Disease Transmissions in Policy 15.4.A Host OPO Requirements for Reporting Post-Procurement Donor Results and Discovery of Potential Disease Transmissions is sequential. The second item on the table includes positive blood cultures without any exceptions and this requirement because it is higher in the list would take precedence over the fourth item fungal cultures.

As an OPO, when do I need to report sputum results?

OPOs are required to do the following for sputum results:

  1. Post results to DonorNet

  2. If the results are negative, then posting to DonorNet meets the policy requirements.

  3. If the results are positive, then report positive results (e.g. bacteria or Candida species) to transplant program patient safety contacts that received lungs or head and neck VCAs from the donor within 24 hours

  4. Only report the results to the OPTN Improving Patient Safety Portal if the results indicate a disease included on the pathogens of special interest list.

Histopathology

Would relevant histopathology results reported post-procurement include sclerosing glomeruli?

No.

    Other Psycho-Social

    What would be an example of “Other psycho-social history, medical history, autopsy, testing, and laboratory findings identifying infectious conditions that may adversely affect a potential transplant recipient” that needs to be reported?

    An example might be: No increased risk behaviors were described during the donor assessment, but then a month later a close friend reported that the donor was engaging in unprotected male-to-male sex with intravenous drug users.

    Pathogens of Special Interest

    Where can I find the list of special pathogens? How will I know if it has changed?

    Here is the pathogens of special interest list. A link to the list is available on the Improving Patient Safety reporting page in UNet.

    Patient Safety Contact

    When a Patient Safety Contact listed for a transplant program has no response to your notification, do you have a recommendation of what next step an OPO should do?

    Transplant programs are required to post contact information for a patient safety contact, many programs do provide alternative contact information on the patient safety contact list that is available on the home page of UNet Secure Enterprise.

    Reporting

    Can you give me a summary of all of the OPO reporting changes?

    The policy changes provide specifics on what OPOs must report only to transplant hospital patient safety contacts versus reporting both to the OPTN Improving Patient Safety Portal and transplant hospital patient safety contacts. For details, please see the policy notice. Go to UNOS Connect to access a webinar that explains the 2016 changes.

    As an OPO, what should I do if I am uncertain if I need to report?

    First follow your OPO’s protocol and that should include instructions on what to do when having a question about reporting. Some OPOs direct staff to consult their administrator on call or the medical director.

    What does it mean to obtain and report all deceased donor tests to the OPTN Contractor in Policy 2.13?

    This means that the OPO must have a protocol to obtain all results. This would include a mechanism to follow up and get results on all testing performed. OPOs must ensure that outstanding results are obtained. Reporting tests to the OPTN Contractor is done by uploading the results to DonorNet. All results, whether positive or negative, must be available in DonorNet. OPOs should upload these as soon as they are received.

    Who is responsible for putting the results in Donor Net; the OPO or the receiving transplant facility?

    The OPO.

    If serology results positive for hepatitis C are known at time of recovery and acceptance by the transplant program, then do they still need to be reported to the OPTN and the patient safety contact (PSC)?

    No. The policy applies to results received post-procurement. If a program knows ahead of time that the donor is HCV positive, then the risk is discussed with the recipient ahead of time. If transmission were to occur, it would not be unexpected.

    OPOs frequently receive calls from transplant programs who want to see how other recipients from the same donor are doing when their recipient may have unexpected delayed graft function. They want to see if anyone else who received organs is having an issue. At this point, disease is not confirmed or suspected. The transplant hospital is starting to investigate and not ready to report to the OPTN. Should the OPO submit a PDDTE report to the OPTN (DTAC) even if the transplant program has stated they are not yet ready to report?

    The policy requires reporting when “an organ recipient is suspected to have, is confirmed positive for, or dies from a potential transmissible disease, infection, or malignancy and there is substantial concern that it could be from the transplanted organ.” The scenario described above at that point in time does not fit within the requirement to report.

    How can required negatives be added to DonorNet by the OPO after feedback is closed? Some results may come back after the OPO is no longer able to add attachments.

    The timeframe that OPOs have to upload results to DonorNet will be extended to 180 days. After 180 days, then the OPO can work with the Organ Center to upload results.

    Tissue

    For organ cases that are also tissue recoveries and the processor reports a post implant infection, does this need to be reported or only if a specific reporting disease/pathogen is identified?

    The OPO would handle the test results the same as any result received post-procurement. The result would need to be uploaded to DonorNet and then reporting would be done according to the new policy requirements.

    Toxoplasmosis

    When will testing all donors for toxoplasmosis start? What tests will be acceptable?

    The requirement to test all donors for toxoplasmosis begins April 6, 2017. The requirement is to test for toxoplasma IgG. There are no FDA approved donor screening tests but you can use a test from the list of FDA-cleared assays for use in determining the immune status or the diagnosis of toxoplasmosis, including trade names, specimen collection information, and manufacturer.

    Will the toxoplasma IgG testing be required to be uploaded to DonorNet to run a heart match or can it be reported after the case within 24 hours of obtaining results?

    No the toxoplasmosis results will not be required to run a heart match. The results will not impact the heart match run.

    Is toxoplasma IgM required or can we just run toxoplasma IgG?

    Only toxoplasma IgG is required by OPTN policy.

    Transplant Hospitals

    Cultures

    Will a kidney-only program still get sputum culture results?

    The patient safety contact (PSC) at a kidney-only program will not receive the 24 hour required notification, as positive respiratory samples (bacterial or Candida species) will be reported to transplant programs receiving lungs or head and neck VCAs. The results, however, will be posted to Donor Net.

    Patient Safety Contact

    Will there be a mechanism for patient safety contacts (PSCs) to obtain positive culture results, etc. solely via UNet? The current system of needing a login for each OPO's secure email system is excessively complicated and a burden to the center's PSC.

    All results will be required to be uploaded to DonorNet. The results can be accessed in that manner. The OPO, however, is still required to notify the PSC as soon as possible but no later than 24 hours. OPTN policy does not specify the mechanism of that notification. A pilot is also being developed to allow PSC notification through UNet but this is not yet tested nor ready for general release.

    Requirements

    How have the requirements for transplant hospitals changed?

    Requirements for transplant hospitals have not changed. Transplant hospitals must continue to report suspected cases of donor-derived transmissions.

    Living donor recovery hospitals

    Cultures

    How would a positive urine culture (resulted after recovery) on a living kidney donor need to be reported?

    The positive urine culture should be reported to the recipient center as soon as possible but within seven days of receipt of the results.

    Requirements

    What are the new requirements for living donor recovery hospitals?

    One new clarification in living donor recovery hospital policy is that they must report as soon as possible but “no more than seven days after receiving the new information” for risk of potential disease transmission of disease or malignancy. Other than this timeframe clarification, living donor recovery hospitals should continue to report suspected cases of donor-derived transmissions to recipient transplant hospital safety contacts and the OPTN Improving Patient Safety Portal.

    Access resources for transplant professionals:
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