Organ Donor Infectious Disease Testing Process
If you have questions about this change, please contact your designated hospital services specialist or the UW Organ and Tissue Donation office at (608) 265-0356.
Prior to July 1, 2009, all testing was done at UW Hospital in Madison, Wisconsin. Now some testing will be done at UW Hospital and some testing will be done at the Blood Center of Wisconsin (BCW) in Milwaukee, Wisconsin. The reason for the change is to improve the testing methods for infectious disease testing and to meet new regulatory requirements.
Impact on Hospitals
- Two kits will need to be prepared and labeled for testing. (See FAQ below for details.)
- One kit will go to UW Hospital and one kit will go to BCW. UW Organ and Tissue Donation will still arrange transportation and communication for the pickup location at each hospital.
- There will be an estimated one-hour increase in the time it takes UW Organ and Tissue Donation to get infectious disease testing results.
Organ Donor Infectious Disease Testing Frequently Asked Questions
Q: What tests are performed?
A: UW Organ and Tissue Donation performs the following infectious disease testing in compliance with the United Network for Organ Sharing (UNOS) standards for every organ donor:
- HIV I/II
- HTLV I/II
- Anti-HBC (Hepatitis B Core)
- HBS Ag (Hepatitis B Surface Antigen)
- HCV (Hepatitis C Core)
- RPR or VDRL (Syphilis)
- CMV (Cytomegalovirus)
- EBV (Epstein-Barr Virus)
UW Organ and Tissue Donation also collects blood for tissue typing purposes, which helps match potential donors and recipients.
Q: How do the samples get from the donor hospital to the testing facilities?
A: UW Organ and Tissue Donation prepares blood tube kits and stocks them at most donor hospitals for the nursing staff to use upon the UW Organ and Tissue Donation coordinator's verbal order during an organ donation case. UW Organ and Tissue Donation arranges a courier to pick up the blood at the donor hospital and transport it to the lab for infectious disease testing. This transportation process also includes blood samples for tissue typing to be done at UW Hospital and Clinics.
Q: Why will the infectious disease testing now be done at the Blood Center of Wisconsin?
A: There are three main reasons for this change:
- Nucleic Acid Testing (NAT): The industry standard is changing in donor infectious disease testing. NAT 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. NAT shortens the window of detection for HIV and HCV from approximately 22 days to five days and for HBV and WNV to one day. NAT is approved by the FDA for donor screening. Currently 45 out of 58 OPOs are performing NAT. NAT is not currently done at the UW lab but it will be done with this change to the Blood Center of Wisconsin.
- FDA-Approved Testing for Screening: In early 2008 Abbott labs discontinued its FDA approved kit, being used by UW Hospital and Clinics Core Lab for Hepatitis B, Hepatitis C, HIV. In response to this, the UW Hospital and Clinics lab applied for an exemption from UNOS to utilize non-FDA approved testing for screening but approved for diagnostics, Centaur. The exemption was granted by UNOS on March 14, 2008 and current testing for organ donors is being done using this method of testing. However, the pancreatic islet transplant program cannot use these results because they are regulated by the FDA. As a result, testing for potential islet donors has been done at the Blood Center of Wisconsin in Milwaukee, creating two sets of standards for donor testing.
- Anticipated Changes to CMS Regulations: Draft language for the CMS regulations for OPOs is suggestive that CMS will begin requiring OPOs to conduct NAT on high risk donors. Defining a high-risk donor and creating two sets of donor testing standards is a challenge. In an effort to meet industry standards and be prepared for CMS regulatory changes, UW Organ and Tissue Donation has decided to begin NAT on all donors.
Q: Were other implementation options explored?
A: Yes. The option of bringing the testing in-house to UW Hospital and Clinics was, and still is, being considered. The timeframe for this to occur was outside of the timeframe we wanted for implementation of the new testing. Very few labs in the United States perform this testing on a STAT basis. The Blood Center of Wisconsin was the closest location that could accommodate our needs, with a minimal impact on the length of time for results.
Q: What will be the implication for timing during cases?
A: Our current turnaround time is four hours from the time the sample is received at the lab until results are done. If there is a failed test or a positive result, it takes an additional four hours. The new tests run at BCW will take four hours from the time the sample is received until results are done. And again, if there is a failed test or a positive result, it will take an additional five hours. There will be an estimated additional one hour of transportation time.
Q: Does this change impact the tissue or eye donation process?
A: No. This change only applies to potential organ donors.