President’s Desk Column

Of tissues, organs,and pathologists

February 2002
Paul A. Raslavicus, MD

We all recognize transfusion medicine and blood banking as an integral part of clinical pathology. What is surprising is that despite our stewardship of laboratories and tissue storage facilities, only a minority of pathologists is involved with tissue banking or organ procurement organizations (OPOs). It is a professional activity that involves patient care through laboratory means and an opportunity for pathologists to expand their patient care horizons.

In contrast to the extensive government regulation of OPOs and the peer accreditation programs for clinical laboratories, tissue banking has had minimal government oversight and less than universal private-sector accreditation. A report from the Office of Inspector General a year ago said there is no required registration of tissue banks, and New York and Florida are the only states that require registration and inspection. In the voluntary accreditation program of the American Association of Tissue Banks, only 58 of 148 banks that the IOG could identify participate. The Food and Drug Administration’s scope of oversight was described as limited to donor screening for HIV and hepatitis. The Office of Inspector General called for more government regulatory oversight.

Prompted by these quality issues and concerned about adverse publicity with respect to informed consent and the service charges for procured tissue, the College created an Ad Hoc Committee on Tissue and Organ Procurement, chaired by CAP governor Gene Herbek, MD. The Board of Governors has accepted a number of the committee’s recommendations for College action. They are as follows:

• Review CAP policies on the sale of organs and tissues and the use of human tissue in research, education, and quality control.
• Review the autopsy authorization form to ensure appropriate disclosure and informed consent for the retention of tissues.
• Cooperate with the American Association of Tissue Banks and other organizations to promote appropriate disclosures to potential donors or families, to endorse appropriate current AATB standards, and to evaluate the need for further uniform standards associated with the practice of tissue banking.
• Support the development of a database on the demand and availability of tissue and organ resources.
• Work with the National Association of Medical Examiners and American Society of Forensic Sciences to encourage coroners and medical examiners to report appropriate cadavers to tissue and organ banks.
• Develop a communications plan to disseminate CAP policies on tissue procurement and distribution and collaborate with other organizations on public education about tissue donation.
• Monitor existing and proposed FDA regulations, as well as activities of the National Institutes of Health and the Centers for Disease Control and Prevention, related to tissue banking and informed consent for tissue donation.
• Serve as a resource to the FDA, NIH, and CDC to help ensure the safety of imported and domestic harvested tissue.

The Board also acted on a House of Delegates resolution with respect to tissue banking training for pathologists. It referred this matter to the Council on Practice and Education for further discussion on the development of educational tools in this field of medical practice.

In contrast to tissue banking where quality has been a chief concern, within the organ transplantation field all physicians have been concerned about the costs of procuring a donated organ and organ availability for a specific patient. The National Organ Transplant Act of 1984 espoused voluntary organ donation based on the principle of munificence, which the College has endorsed. The College has also this year joined the Workplace Partnership for Life program, an initiative of the secretary of Health and Human Services, which makes donation information available to our employees. Yet, despite vigorous efforts to promote altruistic donations, the shortage of cadaveric organs has not diminished; rather, it has increased dramatically. In the four years 1998 through 2001, 21,530 patients died waiting for a transplant—that’s 15 deaths each day. The United Network for Organ Sharing is faced daily with the need to allocate this scarce and desirable resource. The ethical decisions as to who receives a lifesaving transplant and who does not are difficult. Should the sickest be transplanted first, or should we favor a triage system looking toward the number of additional life-years? Should we look for the best biologic match nationwide or simply within a region? Should we favor those who have been alloimmunized when we know the transplant success rate is lower?

As responsible professionals, we must participate in a reasoned debate on the best way to increase the availability of cadaveric organs. It is not too surprising that ethicists, economists, libertarians, and the American Medical Association are all reexamining donor motivation. The questions of directed donation (Sade RM. Arch Intern Med. 1999;159: 438-442) and financial incentives for cadaveric donation are front and center. Ethical principles of physicians’ paramount obligation to their patients and their support of access to care require that alternatives be examined. While legislation has been passed in Pennsylvania permitting subsidy of funeral expenses of those whose organs are donated at death, this statute cannot be implemented because the 1984 Transplant Act prohibits such payment. In response, bills are being introduced in Congress that would permit financial return through tax credits for the donation of cadaveric organs. The AMA’s Council on Ethical and Judicial Affairs has recommended that the role of financial incentives to encourage cadaveric donation be studied using the principles of scientific research. The AMA House of Delegates, demonstrating the extensive divisions within the medical profession on this question, did not adopt this suggestion.

We physicians know that the answers to life and death questions are never simple. We must all participate in formulating the policies for these critical patient care activities. And, whenever the need arises, we, as practitioners, need to lend a hand in our own hospitals, medical centers, or wherever we practice, in matters of tissue banking and organ procurement.