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Proposal to Modify Deceased Donor Testing Requirements

Proposal to Modify Deceased Donor Testing Requirements

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Proposal to Modify Deceased Donor Testing Requirements

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  1. Proposal to Modify Deceased Donor Testing Requirements Ad Hoc Disease Transmission Advisory Committee (DTAC) Committee Fall 2013

  2. The Problem • What does “commercially available” really mean? • Current testing requirements do not reflect updates to testing technology

  3. Goal of the Proposal • Enhance patient safety • Eliminate confusing policy language • Re-organize policy to be more clear and concise • Bring testing language in line with current laboratory practices

  4. How the Proposal will Achieve its Goal • Replace general screening test requirements with test-specific requirements • Remove the term “commercially available” • Provide new option for completing deceased donor HIV testing • Simplify requirement for syphilis testing • Add flexible language for Toxoplasma screening testing • Address a request to eliminate urine culture when urinalysis results are negative

  5. Supporting Evidence • HIV antigen/antibody combination testing recommended in 2013 PHS Guideline • not meant to replace NAT • Reduce the window period for recognizing infection • Feedback sought from the FDA • Syphilis test options are equally effective and offer OPOs more flexibility • Toxoplasma screening already requested regularly by heart transplant programs

  6. Table 1: Estimates of window period length for different testing methods1 1 Humar, A., Morris, M., Blumberg, E., Freeman, R., Preiksaitis, J., Kiberd, B., Schweitzer, E., Ganz, S., Caliendo, A., Orlowski, J. P., Wilson, B., Kotton, C., Michaels, M., Kleinman, S., Geier, S., Murphy, B., Green, M., Levi, M., Knoll, G., Segev, D., Brubaker, S., Hasz, R., Lebovitz, D. J., Mulligan, D., O’Connor, K., Pruett, T., Mozes, M., Lee, I., Delmonico, F. and Fischer, S. (2010), Nucleic Acid Testing (NAT) of Organ Donors: Is the ‘Best’ Test the Right Test? A Consensus Conference Report. American Journal of Transplantation, 10: 889–899. doi: 10.1111/j.1600-6143.2009.02992.x

  7. What Members will Need to Do • Familiarize yourself with new testing policies • Work with laboratory provider(s) to ensure that your OPO will remain in compliance with new and modified requirements • Modify internal policies or operating procedures • Update internal forms or data collection tools • Train relevant staff regarding internal and OPTN policy changes (those potentially affected include lab staff, data entry staff, coordinators, etc)

  8. 2013 PHS Guidelines Update • Updates to current policy references for PHS Guidelines use in medical-social evaluation • Joint Subcommittee completing page-by-page review of PHS recommendations • Considering impact on living and deceased donors, and all organ recipients

  9. Questions? • Michael Green, MD, MPH, Committee • Regional Presentername@email • Shandie Covington, Committee