January 2000

Informational Bulletin 00-1

Hospital Conditions Of Participation For Organ, Tissue And Eye Procurement


The purpose of this Information Bulletin is to relay information regarding a new Condition of Participation for Organ, Tissue and Eye Procurement for hospitals participating in the Medicare and/or Medicaid Programs. The Condition of Participation for Organ, Tissue and Eye Procurement imposes several requirements a hospital must meet that are designed to increase organ donation. One of these requirements is that a hospital must have an agreement with the Organ Procurement Organization (OPO) designated by the Secretary, under which the hospital will contact the OPO in a timely manner about individuals who die or whose death is imminent in the hospital. The OPO will then determine the individual's medical suitability for donation. As well, the hospital must have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes, as long as the agreement does not interfere with organ donation. The final rule requires a hospital to ensure, in collaboration, with the OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement or organs and tissues take place. In addition, transplant hospitals must provide organ-transplant-related data, as requested by the Organ Procurement and Transplantation Network (OPTN), the Scientific Registry, and the OPO's. The hospital must also provide, if requested, such data directly to the Department of Health and Human Services. The regulation is the centerpiece of the National Organ and Tissue Donation Initiative, which has as its goal a 20 percent increase in organ donation in the first two years of the regulation.

Health Care Financing Administration (HCFA) published the final rule June 22, 1998. A complete version of the Federal Register notice including comments.

The Interpretive Guidelines for the Condition of Participation for Organ, Tissue and Eye Procurement may be found online.

This is the site for the State Operations Manual. The Interpretive Guidelines for Hospitals is in Appendix A. The table of contents for Appendix A does not include a listing for Condition of Participation for Organ, Tissue and Eye Procurement, but it is included within the body of the Appendix.

If you have any questions regarding this information bulletin, please contact in writing:

Minnesota Department of Health
Health Regulation Division
Licensing and Certification Program
85 East Seventh Place, Suite 300
PO Box 64900
St. Paul, MN 55164-0900

Wednesday, February 04, 2015 at 03:22PM