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HRSA directive to expand OPTN data collection

Published on: Wednesday, February 7, 2024

Topics include pre-waitlist patient referral and evaluation, referral of potential deceased donors

The Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services has directed the OPTN to begin collecting additional data in the following areas:

  • Information from transplant centers about when individuals are first referred to them for an organ transplant, as well as the results of their transplant evaluation and selection as a transplant candidate.
  • Information from organ procurement organizations on all ventilated patients referred to them from hospitals in their donation service area, regardless of whether such individuals progress to organ donation.

Information regarding patient referral and evaluation prior to acceptance as a transplant candidate may yield valuable insight into clinical factors and patterns of behavior affecting access to transplantation. Likewise, baseline data on people most likely to qualify as organ donors can help better estimate donor potential and conversion.

The directive, dated Feb. 5, 2024, instructs the OPTN Contractor to develop new forms and supporting information by March 22, 2024. The directive recommends the creation of two new forms, one for patient referral and evaluation and one for ventilated patient referral.

The proposed new data collection is intended for inclusion in the 30-day Information Request Package (ICR) for the federal Office of Management and Budget (OMB), and for a Federal Register notice seeking public comment on the package. The public will also have the opportunity to comment during the 60-day ICR period on the Federal Register, which will occur prior to the 30-day being published.