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About 50 people a day receive organ transplants in the U.S., but another 10 die each day waiting for a donor. A new regulation by the Department of Health and Human Services (DHHS) calls for revised organ allocation policies that are based on need, rather than geography of the donor. The rule also requires uniform criteria to determine patients' medical status for placement on a waiting list for transplant. There is a 60 day comment period on the new rule, which is scheudled to be effective in 90 days. A hypertext version of the new rule (42 CFR Part 121), and press releases are available from DHHS.

GAO recently tried to assess the performance of Organ Procurement Organizations (OPOs), but found HCFA's methodolgy to be so lacking as to make the assessment impossible.

Organ Procurement Organizations: Alternatives Being Developed To More Accurately Assess Performance. HEHS-98-26. 33 pp. plus 3 appendices (8 pp.) November 26, 1997. Reviews whether the Health Care Financing Administration's (HCFA) population-based standard appropriately measures the extent to which organ procurement organizations (OPO) are maximizing their ability to identify, procure, and transplant organs and tissue.

U.S. Code

Code of Federal Regulations

Legislation/Testimony

Blood Bills (105th Congress)
1997 Congressional Record: "Organ Transplant"
Search "Organ Transplant"

News & Reports

Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain (12/05/97, HEHS-98-25) Evaluating the Food and Drug Administration's oversight of transplanted human tissue as well as potential safety problems, focusing on: (1) gaps in the current regulation; and (2) whether and how FDA plans to address them in the approach it has proposed for regulating tissue banking.
HHS: Recall Of Blood Products In Six States Due To Risk Of Tick-Borne Illnesses
HHS: Reinventing the Regulation of Human Tissue
Health Insurance: Coverage of Autologous Bone Marrow Transplantation for Breast Cancer (Letter Report, 04/24/96, GAO/HEHS-96-83). Although many insurers now cover the cost of autologous bone marrow transplantation, a new and expensive treatment for breast cancer, issues surrounding the procedure have put several goals of the U.S. health care systems in conflict: access to the best, most advanced care; cost containment; and research adequate to assess the value of new treatments.
Blood Supply: Transfusion-Associated Risks (Letter Report, 02/25/97, GAO/PEMD-97-2). The U.S. blood supply is safer today than at any time in recent history, with risks from blood transfusions quite small compared with the benefits of transfusion in saving lives.
Bone Marrow Transplantation: International Comparisons of Availability and Appropriateness of Use (Chapter Report, 03/07/94, GAO/PEMD-94-10). The U.S. health care system has been criticized for encouraging the "overuse" of the newest and most costly medical treatments.
Blood Safety: Enhancing Safeguards Would Strengthen the Nation's Blood Supply (Testimony, 06/05/97, GAO/T-HEHS-97-143). GAO discussed its two reports on the safety of the nation's blood supply, focusing on: (1) the current risks of blood transfusion; (2) the content and quality of data collected to assess these risks; and (3) the Food and Drug Administration's (FDA) layers of safety and their ability to ensure the safety of the nation's blood supply.
Organ Procurement Organizations: Alternatives Being Developed To More Accurately Assess Performance. HEHS-98-26. 33 pp. plus 3 appendices (8 pp.) November 26, 1997. NIH-Funded Research: Therapeutic Human Fetal Tissue Transplantation Projects Meet Federal Requirements (Letter Report, 03/10/97, GAO/HEHS-97-61). Pursuant to a legislative requirement, GAO reviewed the fetal tissue transplantation research funded by the National Institutex of Health (NIH) under the NIH Revitalization Act, focusing on: (1) compliance with informed consent and other documentation; and (2) any violations occurring in the acquisition of human fetal tissue for use in transplantation.
Blood Supply: FDA Oversight and Remaining Issues of Safety (Chapter Report, 02/25/97, GAO/PEMD-97-1). Pursuant to a congressional request, GAO evaluated the Food and Drug Administration's (FDA) "layers of safety" that provide the framework for regulating and monitoring the U.S. blood industry, focusing on the actual and potential vulnerabilities in the layers of safety that may present a threat to the public health.
Blood Supply: Transfusion-Associated Risks (Letter Report, 02/25/97, GAO/PEMD-97-2). The U.S. blood supply is safer today than at any time in recent history, with risks from blood transfusions quite small compared with the benefits of transfusion in saving lives.
About Organ and Tissue Donation and Transplantation In 1993 in the United States there were more than 18,000 organ transplants.
Approved Blood Lead Laboratories Provided on WWW and Gopher by USDOL OSHA - OCIS.
FAQ on Organ Donation Commonly Asked Questions on Organ Donation.
FDA News Recent news from the Food and Drug Administration.
HIV Blood Money When I was 5 years old I was diagnosed as having severe hemophilia. In 1986 I was diagnosed as HIV+.
hong_kong_red_cross_bans_gays_ The Red Cross yesterday stood firmly by its policy to ban homosexuals and bisexuals from donationg blood despite strong opposition from local gay groups.
How to use this card Both steps are required for organ donation to take place after death, because doctors will ask your family for permission to use your organs even if you sign a donor card.
Human Blood Types Reference Blood is grouped into four types: A, B, AB, and O. Each Type is also classified by an Rh factor - either positive (+) or negative (-).
LEGAL RESTRICTIONS ON THE ADVERTISING AND PROMOTION OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS ON THE INTERNET There is thus little to guide companies who are contemplating marketing over the INTERNET and other new methods of electronic communication except current laws, regulations, and regulatory guidance.
Making Your Voice Heard at FDA As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation- emitting electronic products, and medical devices-- commodities close to the daily lives of all Americans.
Options for Increasing Organ Donation: The Potential Role of Financial Incentives Required request laws that mandate hospital personnel to request organ donations have not substantially increased the supply of organs for transplantation.