New rules released this week by federal organ donation regulators will leave many hospitals ill-prepared to handle new patient-tracking and reporting requirements, The New York Times reported.
The board of the United Network for Organ Sharing (UNOS) on Monday voted to create uniform minimum standards, at the urging of the U.S. Department of Health & Human Services, which called on UNOS to make voluntary standards mandatory.
Among the changes, hospitals' transplant programs must report clinical information on at least 80 percent of living kidney donors and kidney function lab results on at least 70 percent on donations after Dec. 31, 2014, according to a UNOS statement Tuesday. Results must be reported at six months, one year and two years, the NYT noted. Before 2015, though, hospitals are required to phase in outcome data reporting.
"Lower, intermediate thresholds for reporting living kidney donor outcome data will apply to living kidney donors who donate after February 1, 2013," UNOS said.
According to UNOS, hospitals only report on 65 percent of donors and lab data for fewer than 40 percent. Stuart M. Flechner of the Cleveland Clinic said 9 out of 10 hospitals would currently not meet the new requirement.
The organ donation network, however, said some hospitals may already be in compliance.
"Some individual transplant programs already meet the requirements we have established," OPTN/UNOS President John Roberts said. "Our goal is to ensure that all programs meet these standards."
UNOS was originally dedicated to donations from deceased donors, but with more donations from living patients, UNOS is now focused on encouraging transplants while offering safeguards for living patients. Out of about 70,000 kidney donations between late 1999 and early 2011, 27 died within two years of medical causes that may or may not have been related to donation, according to the NYT.
Among other policy changes, hospitals must:
- Follow a minimum set of required tests and procedures for medical and psychosocial evaluation of potential living kidney donors
- Follow a minimum set of requirements for informed consent for the donation procedure
- Appoint an independent advocate to counsel and represent donors
For more information:
- read the NYT article
- see the UNOS statement
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