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Proposal to Modify Deceased Donor Testing Requirements

Proposal to Modify Deceased Donor Testing Requirements. Ad Hoc Disease Transmission Advisory Committee (DTAC) Committee Fall 2013. The Problem. What does “commercially available” really mean? Current testing requirements do not reflect updates to testing technology. Goal of the Proposal.

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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 ChairMichael.Green@chp.edu • Regional Presentername@email • Shandie Covington, Committee Liaisonshandie.covington@unos.org

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