1. Organ Donor Infectious Disease Testing Education UW Health OPO July 2009

2. UW health OPO performs the following infectious disease testing in compliance with the United Network for Organ Sharing (UNOS) standards for every donor: HIV I/IIHIV I/II HTLV I/IIHTLV I/II Anti-HBc (Hepatitis B Core)Anti-HBc (Hepatitis B Core) HBsAg (Hepatitis B surface antigen)HBsAg (Hepatitis B surface antigen) HCV (Hepatitis C)HCV (Hepatitis C) VDRL/RPR (Syphilis)VDRL/RPR (Syphilis) CMV (Cytomegalovirus)CMV (Cytomegalovirus) EBV (Epstein-Barr Virus)EBV (Epstein-Barr Virus)

3. Current Challenges Early 2008 – Abbott labs discontinued FDA approved kit used by UWHC for Hepatitis B, Hepatitis C & HIVEarly 2008 – Abbott labs discontinued FDA approved kit used by UWHC for Hepatitis B, Hepatitis C & HIV UW Health OPO given exemption by UNOS to perform diagnostic testing, CentaurUW Health OPO given exemption by UNOS to perform diagnostic testing, Centaur

4. Current Status Donor serological testing is generally done at UW via diagnostic method.Donor serological testing is generally done at UW via diagnostic method. Only exception is in the case of a potential islet donor. These panels are sent to BCW (BloodCenter of Wisconsin) for FDA approved serologies.Only exception is in the case of a potential islet donor. These panels are sent to BCW (BloodCenter of Wisconsin) for FDA approved serologies. July 1, 2009 – All donor serological testing will be done at BCW, including NAT and WNV.July 1, 2009 – All donor serological testing will be done at BCW, including NAT and WNV. The only blood testing done at UW will be ABO verification, EBV (send out) and HLA.The only blood testing done at UW will be ABO verification, EBV (send out) and HLA.

5. BloodCenter of Wisconsin Open since 1947 and located in Milwaukee, WIOpen since 1947 and located in Milwaukee, WI On call staff enables donor testing 24 hrs a day 365 days a yearOn call staff enables donor testing 24 hrs a day 365 days a year Approved for NAT testing on all donorsApproved for NAT testing on all donors

6. NAT Testing The industry standard is changing with regard to infectious disease testing.The industry standard is changing with regard to infectious disease testing. NAT (Nucleic Acid Testing) detects the genetic sequence of the virus, bacterium or parasite that is present in the host as a result of the infection.NAT (Nucleic Acid Testing) detects the genetic sequence of the virus, bacterium or parasite that is present in the host as a result of the infection. It is used for HIV, HCV, HBV and West Nile Virus.It is used for HIV, HCV, HBV and West Nile Virus. NAT shortens the window of detection for HIV & HCV from approximately 22 days to 5 days and for HBV and WNV to 1 day.NAT shortens the window of detection for HIV & HCV from approximately 22 days to 5 days and for HBV and WNV to 1 day. Currently 45 out of the 58 OPOs are performing NAT.Currently 45 out of the 58 OPOs are performing NAT.

7. New Process Initial donor blood draw will now need to be shipped in 2 packagesInitial donor blood draw will now need to be shipped in 2 packages Package 1—sent to BloodCenter of WI Package 1—sent to BloodCenter of WI 3 7 ml EDTA (lavender) tubes 2 10 ml serum sample (red top—NOT serum separator) tubes Package 2—sent to UW Package 2—sent to UW 4 10 ml ACD (yellow top) tubes4 10 ml ACD (yellow top) tubes 1 5 or 7 ml lavender tubes1 5 or 7 ml lavender tubes

8. New Process For each bagFor each bag Affix a label including patient’s first and last name, date of birth, date and time of draw and initials of person drawing Affix a label including patient’s first and last name, date of birth, date and time of draw and initials of person drawing Place the tubes in a biohazard bag and then package in a small box or envelope Place the tubes in a biohazard bag and then package in a small box or envelope Write: To BloodCenter of WI on package 1 Write: To BloodCenter of WI on package 1 To UW Hospital ER on package 2 To UW Hospital ER on package 2

9. New Process Take samples to your ER triageTake samples to your ER triage A courier will be arranged to transport the samples from your ER to their destinationA courier will be arranged to transport the samples from your ER to their destination Please call organ procurement coordinator on call with any questions: 608-262-2122Please call organ procurement coordinator on call with any questions: 608-262-2122

10. New Timeline Once blood arrives to BCW serology testing takes 4-6 hrs to complete; if any results are positive the test needs to be re- run and take an additional 4-6 hrsOnce blood arrives to BCW serology testing takes 4-6 hrs to complete; if any results are positive the test needs to be re- run and take an additional 4-6 hrs Once blood arrives to UW EROnce blood arrives to UW ER ABO takes under an hour ABO takes under an hour EBV needs to be sent out and results arrive in 5 to 7 days EBV needs to be sent out and results arrive in 5 to 7 days HLA (tissue typing) takes about 4 hours HLA (tissue typing) takes about 4 hours

11. Thanks for your assistance!!