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Lab

Policy changes affecting labs

The OPTN/UNOS Board of Directors approved a number of policy changes in the last year that specifically affect histocompatibility laboratories. Many of these changes will take effect by the beginning of 2016 and we want to make sure you and your staff are prepared.

This table gives you a snapshot of the changes and points you to relevant policy language and related notices you should have previously received.

What’s different What does this mean for you? Links to more information Effective date
Deadlines for reporting resolution of data discrepancies We have always required that  HLA discrepancies in UNet℠ be resolved, however, now these must be resolved within 30 days of the time the discrepancy appears in UNet See July 2014 policy notice for more information.

Reference the June 24 system notice in UNet (login required) by searching the archive. Policy 4.2 contains language about resolving discrepant donor and recipient HLA typing results.

June 24, 2015
DQA1 and DPB1 will be required fields in DonorNet. This typing will be required before OPOs can offer an organ from a  kidney or pancreas/kidney-pancreas match. Work with your affiliated OPOs to ensure that this is included in the typing you perform on their behalf. If you do not report values for DQA1 and DPB1, they will be unable to make organ offers for kidney, kidney-pancreas, pancreas and/or pancreas islets. See Nov. 2014 policy notice. January 2016
Bylaws Rewrite Part 2—Reporting Key Personnel to the OPTN In addition to the other key personnel positions you already report to us, you need to now include your General Supervisor. See July 2015 policy notice. 2nd quarter of 2016
Monitoring labs in terms of OPTN compliance ASHI and CAP surveyors will begin to monitor your organization for compliance with  OPTN/UNOS  policies and bylaws. If you are audited by both ASHI and CAP surveyors, you will tell us which one you want reviewing the OPTN/UNOS policies. Additionally, if there are specific concerns, ASHI or CAP may return for off-schedule reviews and report those findings to the MPSC. We will update the Evaluation plan to reflect the policies and bylaws that either your ASHI or CAP surveyor will review. 4th quarter of 2016

If you have any questions or concerns about any of the above changes, please contact UNOS at 804-782-4800 and ask to speak with your regional administrator.

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