Of tissues, organs,and pathologists
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
- 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
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.