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U.S. Department of Health and Human Services Recommendations 19-28

The Committee met on May 22-23, 2003 and unanimously agreed on the following ten consensus recommendations.

Recommendation 19: That the primary principle in organ donation be honoring the donor's wishes and fulfilling the donor's intent. This principle is known as donor designation.

ACOT affirms the right of individuals to donate their organs and tissues at death.

The wishes of the decedent donor should not be overruled when the organs and tissues are medically acceptable.

This donor rights model acknowledges individual self-determination and social responsibility in the exercise of choice to be a donor.

This Recommendation relates to donation only. Procurement, allocation and transplantation are still governed by the rules of the OPTN and medical judgment.

While fulfilling donor wishes, procurement agencies and hospital staff must continue to be sensitive to the needs of, as well as provide active and adequate support and care for, the families involved.

The legal system should provide an ongoing opportunity for persons to make their wishes regarding organ and tissue donation known and should facilitate the implementation of the donor's wishes. The Secretary should continue to use his good offices to encourage states in this regard.

Educational initiatives should provide training to OPO and hospital staff and information to the public about the primacy of donor wishes. Currently, a mixed message is being disseminated, because members of the public are encouraged to sign a donor card, but are also told they may not be donors if they have not shared their wishes with their families.

Donor Designation. We refer above to the approach recommended here as the honoring of the donor's wishes and the fulfilling of the donor's intent. This practice of proceeding with donation based on the pre-death decision of the donor has occasioned multiple descriptions: first person consent, donor designation, and donor authorization are most prominently employed. From a legal perspective, the donation decision more appropriately fits under the context of a "gift" rather than an "informed consent." Moreover, we believe that the donor is making an autonomous decision and not merely permitting or authorizing others to fulfill the donor's wishes. For the sake of consistency and clarity, therefore, we recommend that the term "donor designation" be adopted as the preferred and more accurate description of this practice.

ACOT notes that the approach recommended here has been endorsed by the Association of Organ Procurement Organizations, and received major support at a recent United Network for Organ Sharing consensus conference. Additionally, the National Kidney Foundation, the Coalition on Donation, the American Society of Transplantation, and the American Society of Transplant Surgeons are all actively considering endorsement of this approach.

Recommendation 20: That updated provisions of the Uniform Anatomical Gift Act with respect to donor rights be fully implemented in all states where the UAGA has been adopted, and that those or substantially similar provisions be enacted in all other states.

In 1968, the National Conference on Commissioners for Uniform State Laws promulgated the Uniform Anatomical Gift Act (UAGA) that authorized persons 18 years of age or older to make a gift of any part of their bodies, such gift to take effect upon death. The Act further provided that, this gift could not be rescinded by another party without the donor's consent. Over the next decade, this provision was adopted by the legislatures of all 50 states.

In 1987, the National Conference on Commissioners for Uniform State Laws promulgated amendments to the Uniform Anatomical Gift Act, which had as their expressed purpose the encouragement of organ donations. The specific language employed in the law is: "An anatomical gift that is not revoked by the donor before death is irrevocable and does not require the consent or concurrence of any person after the donor's death." This amendment to the UAGA was endorsed by the American Bar Association and has so far been enacted in the following jurisdictions:

  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Louisiana
  • Minnesota
  • Missouri
  • Montana
  • Nevada
  • New Hampshire
  • New Mexico
  • North Dakota
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Dakota
  • Tennessee
  • Utah
  • U.S. Virgin Islands
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin

Additionally, the following states have retained the 1968 language, but adopted separate provisions that convey the intent of the 1987 language to honor the donor's designation:

  • Kentucky
  • New Jersey
  • North Carolina
  • Ohio
  • South Carolina

Accordingly, it should be noted that 39 of the 50 states effectively have donor designation provisions.

Remaining jurisdictions — ones that only have the 1968 language — are:

  • Alabama
  • District of Columbia
  • Guam
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Mississippi
  • Nebraska
  • New York
  • Oklahoma
  • Texas
  • Wyoming

Many legal scholars would contend that the original 1968 UAGA made clear that a donor's anatomical gift does not require the consent of anyone else. The amended 1987 UAGA removed any doubt about that interpretation. Thus, according to the Act, as amended, an anatomical gift is irrevocable at death.

Despite the law, however, a telephone poll of OPOs indicated that a majority would refuse an anatomical gift if the donor's family objects, although it is not clear why. This practice could be based on a concern about potentially adverse publicity and the effect that might have on the overall rate of donation. Alternatively, this practice might be based on a natural tendency to exhibit greater respect for the wishes of living persons present than for those of the decedent. OPOs may also feel free to refuse an anatomical gift because the law imposes no penalty for failing to comply with the donor's wishes. Another possible reason could be an unfounded fear of legal liability if the OPO acts on the donor's designation against the wishes of the family.

ACOT specifically recommends that every OPO and hospital in a state that has enacted the UAGA, as amended, should be educated in the implications and enforcement of the UAGA. ACOT further recommends that OPOs and hospitals in states that have not adopted the amendments to the UAGA, or substantially similar provisions, should work with their state legislatures to enact laws that enforce the donor designation model.

Attached to this Recommendation is Appendix 6 — Donor Designation: State Law and OPO Practice, which details, state by state, the current law and OPO policy position in every state (and three other U.S. jurisdictions) where such information could be ascertained. The OPO policy position reflected in Appendix 6 is based only on a telephone poll, and thus might not reflect recent changes in practice. ACOT is aware of and encouraged that the National Conference on Commissioners for Uniform State Laws will this summer be considering yet another revision to the UAGA, so as to bring those provisions up to date with the many changes in practice since 1987, including the 1998 Medicare Conditions of Participation, which effectively superceded the 1987 language defining the obligations of hospitals to ask families about donation.

Thus, ACOT recommends that a comprehensive review and updating of the laws governing anatomical gifts take place in each state and that all states be encouraged to adopt laws intended to uphold the intent of donors. The very most recent state reforms in Virginia and Florida provide good models for other states. The Virginia code, for example, declares: "An anatomical gift, regardless of the document making such gift or donation, that is not revoked by the donor before death is irrevocable and does not require the consent or concurrence of any person after the donor's death."

Finally, as the Virginia code provision implicitly recognizes, individuals have a right to authorize or to decline donation. A donor may revoke an authorization, or decide to donate, at any time before death. Any revised law should also address how a donation can be revoked. A recently enacted Florida provision, for example, allows a person to change or revoke plans to donate organs by telling at least two people, one of whom must not be a relative. It should be clear, therefore, that the primary purpose of Recommendations 19 and 20 is to honor and support the intent of the donor, whatever that intent may be.

Recommendation 21: That HHS direct the OPTN and SRTR to rename and broaden the scope of the present cadaver donor registration form to meaningfully capture whether donor wishes are expressed prior to the time of death, to determine whether donor wishes are being honored, and, if not, to ascertain what conditions prevented the fulfillment of the donor's wishes.

The current reporting of information on an individual potential donor's decisions regarding donation is confusing and of limited value for any analysis. For each organ donor, two questions address a donor's wishes, but, because of the wording of the questions and the limited rigorousness of the reporting, any analysis of the reported data is necessarily inconclusive. The OPTN form must be revised to completely capture necessary information. For example, as the practice of honoring donor wishes has been endorsed by ACOT, AOPO and other organizations, it is critical to ascertain whether OPOs comply with this practice. The high incidence of "Unknown" responses likely reflects the current practice in many OPOs of not actively seeking this information as part of the family consent discussion, but this must also be investigated.

ACOT recommends that the confusing and sometimes inappropriate terminology used in this area needs to be brought up to date and applied consistently. In this regard, we have made two specific recommendations. The first was with respect to the phrase "Donor Designation," and we described our position in this regard in Recommendation 19. The second concerns the overbroad use of the term "cadaver."

Deceased Donor. The current OPTN reporting form gathering information on the donor is titled the "Cadaver Donor Registration Form." Many in the donation and transplantation community regard the term "cadaveric" as unduly harsh and disrespectful to the families of donors. They have requested that professionals use the term "deceased donor" wherever practicable. We support this change in the OPTN form, and in all donation and transplantation nomenclature, to "deceased donor."

Recommendation 22: That the use of split livers be encouraged as a matter of national policy.

When evaluating split liver transplantation as an option, the parameters that should be considered include wait list mortality and survival after split liver transplantation. On a national policy basis, and based on the available outcomes data, ACOT believes that, for adult/pediatric splitting, whenever it is technically feasible to do so, splitting should be encouraged. Specifically, ACOT encourages the OPTN Liver Committee to develop policy changes that would maximize the use of split livers. Such a maximization of utility would further respect the kindness of the donor or donor family who generously provided the organ.

Everything else being equal, the plain facts appear to be that a split liver will not be as good for a patient as a whole liver, but that a split liver is better than no liver at all. The overall goal is to increase the number of donors and transplants so that fewer people are forced to remain on the waiting list. The best way to determine the relative risk of using split livers is to compare survival after transplant with a split liver with mortality on the waiting list. SRTR produced tentative yet impressive data showing that, of 162 patients with a split liver, survival at 2 years was actually 20 percent higher than had they remained on the waiting list, which is comparable to the rate for whole organ transplantation. Therefore, for centers with the ability to split livers and pediatric recipients, splitting should be encouraged.

Under the present practice, if an organ can be split, but there is no pediatric recipient in that region, it is not likely that a center, in another region with a pediatric candidate for that small segment, will be called. This is as opposed to the practice in Europe, where good organs are considered two listed livers, and two patient names are automatically issued. ACOT encourages the OPTN Liver Committee to develop a change in policy to maximize the use of splits, as many current policies do not achieve this result. Rather than a separate list for patients willing to accept a split liver, ACOT suggests that the OPTN develop a list of patients who could benefit from such an organ and an allocation scheme for distributing such organs among patients.

Recommendation 23: HHS should convene a consensus conference, involving key members of the transplant community and insurance industry representatives, with the goal of identifying a single reporting mechanism for clinical outcomes data.

There is a clear need to establish one standardized request for information (RFI). Currently, transplant centers must fill out many forms for insurance companies. UNOS developed a standardized form for insurance companies at one point, but many insurance companies have continued to request additional information. A standardized RFI is presently available on the secure web site hosted by the SRTR, and is available to each transplant center. This form is updated on a regular basis, but not all insurance companies have accepted it.

The transplant community reports that completing these forms is time consuming and costly, and that insurance companies often ask for data that transplant centers have already submitted. Completing many often duplicative forms slows the process and diminishes the capacity of centers promptly and efficiently to transplant organs into patients. As a result of these information demands, patients are not receiving transplants or are added to the list too slowly.

On the other hand, some insurance carriers argue that no existing RFI collects sufficient information to satisfy their needs. Part of the purpose of the proposed consensus conference would be an attempt to identify which elements are missing from the standardized RFI, so as to reduce the gap between what has been produced and what is required by insurance carriers.

Many large payers in California have adopted the UNOS RFI and collect other information from the SRTR data. Therefore, a survey sent to the major payers might obviate the need for a costly consensus conference. Most payers with transplant program benefits have a medical director who reviews the completed RFIs. These insurance company medical directors could be asked about additional information needed beyond what is available through the standardized UNOS RFI or SRTR data.

ACOT believes that HHS should review all options and, if necessary, convene a consensus conference, possibly held under the specific auspices of the OPTN, to resolve these issues.

Recommendation 24: That HHS issue a request for proposals for research to define and collect from OPOs and transplant centers those donor and recipient factors in extra-renal organ transplantation that would better explain relative risk of graft loss after transplant.

ACOT has determined that there is a need to better define, at an earlier stage, those organs that have been variously categorized as "marginal," "expanded," or "extended criteria donation (ECD)." (We believe this latter term best describes the organs that are being used with greater frequency today, and will refer to them accordingly.) In particular, potential recipients need to be informed of the risks and benefits of transplant from such ECD donors at the time of listing, and not just when the extended criteria organ becomes available. There is a need to collect such data both to better inform patients about the risks of accepting a particular organ, and to encourage facilities to consider certain organs that they otherwise might not use. This kind of information would inform everyone in the transplant community and be used to inform the patient more fully.

These recommendations focus on extra-renal organs, as specific criteria have already been established for kidneys. The genesis of this recommendation is that the Committee requested data on relative risk, and learned that such data are not presently available.

More data are needed on the recipient data pool and donor data pool to better define relative risk ratios from the point of transplant and, especially, from the time of listing. However, ACOT did not believe it appropriate or desirable simply to add questions to the OPTN forms, which are already too long and cumbersome. Instead, ACOT recommends that the Secretary issue a request for proposals (RFP) for the larger centers to collaborate on collecting data. This RFP could be issued by that the National Institute of Allergy and Infectious Diseases (NIAID). Centers could be chosen for these awards based on consistency in their pre-operative evaluation and post-operative care to ensure that the resulting information is robust. Kidney information from the OPTN is so clear because of the large number of kidney transplants. In other organs, where the numbers of cases of each type of procedure are much more limited, standardization is needed in the way patients are cared for so that other factors can be isolated and identified within the database.

Another rationale for this research is that of utility. At present, we know recipients are better off with an ECD kidney than if they remain on dialysis. For other organs, limited comparable information is available. Organs that do not meet a specific degree of quality are not being used, or are assigned on a delayed basis, so that they are, in effect, being wasted at a high rate. The driving force for the use of such extended criteria organs is to enlarge the pool of available organs so as to benefit more people, i.e., to use organs that would otherwise be wasted, and thus to save people who would die while waiting for an organ. The overall goal of ACOT in this regard is to maximize resources. If a center is willing to use ECD organs, and patients properly understand the risks involved, these centers can be contacted immediately and cold ischemic time can be reduced.

Once the relative risk factors have been developed, the patients' expected survival, using ECD organs, would be calculated based on the risk factors developed. Thus, one end result of this research may be the establishment of a separate list of patients willing to accept such ECD organs, as determined by pre-set criteria.

This is a scientific issue that will require additional resources to address. This recommendation supports the need for better defining the factors that define long-term outcomes, which will require additional study and thus additional funding. HHS could issue an RFP for further studies in these areas.

As a part of this research, ACOT believes that, for every organ, the risk ratio increase for adverse outcomes needs to be defined. The SRTR should continue to study those statistical factors that increase this risk and put it into the perspective of the end-stage renal disease (ESRD) natural history on an ongoing basis. It is apparent that the ECD definition is a fluid one. As other aspects of transplantation medicine improve, overall outcomes should improve as well.

Recommendation 25: That a minimum listing criterion, called the MELD score critical level, should be established by the OPTN/UNOS liver committee based on the MELD score that provides no significant addition of life following transplantation relative to life on the wait list. The MELD score critical level should be reevaluated on a continuing basis, and changes made when appropriate.

Data provided by the SRTR demonstrated that wait list mortality is lower than post-transplant mortality for patients with low MELD scores (mid teens down to 1). Accordingly, patients with low MELD scores, who account for as many as one-third of the patients presently receiving liver transplants, have an improved chance of staying alive if they are not transplanted. This is an important finding and the transplant community must pay a great deal of attention to these data.

On the basis of currently available data, ACOT concurs with the recent recommendation of the OPTN liver committee that the OPTN establish a MELD score of 10 as a lower limit for performing transplantation. This lower limit should be referred to as the MELD score critical level. Patients with such scores (i.e., below the MELD score critical level) have a good chance of doing well while on the wait list and should not undergo transplantation. Exceptions should be permitted, on an individual case-by-case basis, when clinically indicated.

To date, however, the length of follow-up for MELD is limited; the conclusions about patients who receive no benefit from transplant are based on about six months of follow-up. It is possible that, in the longer term, these patients may experience some benefit, although such data are not yet available, and present evidence indicates otherwise. Therefore, further data collection and analyses are essential. Even if patients with lower MELD scores eventually prove to experience some benefit over time, the benefits to patients with higher MELD scores are clearly much greater, and, given the continuing organ shortage, transplantation should be an option primarily for those with higher MELD scores.

A scarce national resource should be allocated only to people who would benefit from it. Some people are too well to benefit, while others are too sick. In the future, it is likely that the upper limits of MELD will also be more clearly defined, i.e., the point where the severity of illness is so great that transplantation would be futile, yielding poor outcomes. ACOT therefore encourages the OPTN liver committee continually to reassess the MELD score critical level, always balancing and considering the potential benefit to individual patients and the appropriate use of a scarce national resource.

Recommendation 26: That Section 105 of Senator Frist's bill (S. 573 ) be endorsed, so as to make clear that the term "valuable consideration," in the National Organ Transplant Act of 1984, does not include familial, emotional, psychological, or physical benefit to an organ donor or recipient.

The National Organ Transplant Act of 1984 (NOTA) [Pub. L. 98-507, 98 Stat. 2344 (1984), 42 U.S.C. Sections 273-274], contains a specific criminal prohibition [NOTA Section 301] against any person receiving "valuable consideration" in exchange for a human organ [42 U.S.C. Section 274e]. Section 301 of the National Organ Transplant Act (NOTA), as amended, reads as follows:

Prohibition of organ purchases

(a) Prohibition

It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.

(b) Penalties

Any person who violates subsection (a) of this section shall be fined not more than $50,000 or imprisoned not more than five years, or both.

(c) Definitions

For purposes of subsection (a) of this section:

(1) The term "human organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.

(2) The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.

(3) The term "interstate commerce" has the meaning prescribed for it by section 321(b) of Title 21.

42 U.S.C. § 274e (emphasis supplied).

Over the years, questions have arisen over the scope and intent of the phrase "valuable consideration," and, given that this is a criminal prohibition, ACOT deems it important to clarify that neither the intent of the drafters nor the present use of this term applies to other than financial exchanges. On March 7, 2003, Malcolm E. Ritsch, Jr., acting as General Counsel to the United Network for Organ Sharing (UNOS), drafted an opinion letter which persuasively argued that NOTA Section 301 did not apply, for example, to such beneficial arrangements as intended recipient exchanges or paired exchanges.

Given the growth of this field, however, and the desirability of such continued innovations as paired exchanges, as well as the fact that no private legal opinion can bind the government or substitute for legislative clarification, ACOT strongly supports the efforts of Senate Majority Leader William Frist as expressed in the legislation which he has introduced in the United States Senate. Specifically, ACOT endorses Section 105 of proposed S. 573:

Sec. 105. Technical Amendment Concerning Organ Purchases.

Section 301(c)(2) of the National Organ Transplant Act (42 U.S.C. 274e(c)(2)) is amended by adding at the end the following: "Such term does not include familial, emotional, psychological, or physical benefit to an organ donor, recipient, or any other party to an organ donation event."

Recommendation 27: That HHS support legislation providing for elimination of the current three-year time limit on Medicare coverage for immunosuppressive drugs for the ESRD population.

Although Medicare does not generally pay for self-administered outpatient prescription drugs, Congress has specifically mandated that the program cover "prescription drugs used in immunosuppressive therapy" furnished to an individual who received an organ transplant eligible for coverage by the Medicare program. Historically, the Medicare immunosuppressive drug benefit was limited first to a one-year period, but legislation enacted in 1993 expanded the benefit to 30 months of coverage from 1995 to 1997, and then to 36 months of coverage beginning in 1998.

In the Medicare, Medicaid, and CHIP Benefits Improvement and Protection Act of 2000 ("BIPA"), Congress eliminated the 36-month limitation for Medicare aged and disabled transplant recipients who were Medicare-eligible at the time of transplant and received a transplant in a Medicare-approved facility. However, some gaps in coverage remain:

  • ESRD Beneficiaries: If Medicare eligibility is based solely on the recipient's end-stage renal disease (ESRD) status, coverage of immunosuppressive drugs ends three years after the transplant, when the recipient's overall Medicare entitlement ends.
  • Aged and Disabled Beneficiaries: Many transplant recipients, particularly non-kidney recipients, were not Medicare-eligible when they received their transplant. When they later become Medicare-eligible, through age or disability, they do not receive the benefit because the statute requires them to be Medicare-eligible at the time of transplant.
  • Medicare Beneficiaries Previously Transplanted in Non-Medicare Approved Facilities: Transplant recipients covered by private or other non-Medicare insurance are not necessarily transplanted in Medicare-approved facilities. When they later qualify for Medicare, through age or disability, they also do not receive the immunosuppressive benefit because the statute covers only those transplanted in a Medicare-approved facility.

Given the life-saving nature of transplantation and the immunosuppressive regime that follows transplantation, there is widespread agreement that the present practice of cutting off payments for such necessary medications for the ESRD population after three years causes great harm, and often results in the waste of scarce organs and mortality for persons otherwise saved through transplantation.

Several bills pending in Congress would rectify this problem by amending Title XVIII of the Social Security Act to eliminate the three-year time limit on immunosuppressive drug coverage for individuals who are eligible for Medicare solely due to their ESRD status. These include: S.178, the Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003, introduced by Senators Durbin and DeWine; S. 191, the Immunosuppressive Drug Coverage Act of 2003, introduced by Senator DeWine; and H.R. 2223, the House companion to the Durbin/DeWine bill, introduced by Representative Camp.

The principles enunciated in these legislative proposals have been discussed for years within the transplant community. Lack of coverage for immunosuppressive medications (which cost up to $25,000 annually) may force transplant recipients to ration their supply, greatly increasing the chance of organ rejection. A 2001 study published in the American Journal of Transplantation found that low-income kidney recipients had significantly greater graft loss after Medicare coverage of immunosuppressive medications ended. This finding was especially significant to poor and minority populations, because 75 percent of the approximately 13,000 individuals who receive kidney transplants each year fall into the low-income category, defined in the study as those making less than $36,000 annually.

Such a graft loss will lead to either death or re-transplantation. Re-transplantation is almost as bad since it prevents an organ from being used by somebody else on the waiting list. Further, many kidney patients do not even consider the possibility of going through transplantation (including the possibility of using a living donor) because of the lack of coverage for anti-rejection drugs. Instead, they opt to remain on kidney dialysis (which Medicare pays for indefinitely, regardless of age, at a cost of approximately $50,000 per year). There is substantial economic evidence, therefore, that providing continuing Medicare coverage for immunosuppressive drugs will actually save costs in the long run for CMS and funding agencies as a whole.

In addition, supporting patient and graft survival through continuing Medicare coverage for immunosuppressive drugs respects the kindness of the donor or donor family who generously provided the organ. With more than 80,000 Americans on transplant waiting lists, it is senseless to risk a successful transplant and donor's gift because of Medicare limitations on immunosuppressive drug coverage.

Recommendation 28: That HHS support legislation providing for elimination of the current requirement that recipients must have been Medicare eligible when they underwent organ transplantation, in a Medicare approved facility, to later receive the immunosuppressive drug benefit when they become Medicare eligible through age or disability.

This feature is contained in some of the legislative proposals enumerated above in Recommendation 27, as well as in separate bills introduced by Representative LaTourette (H.R. 588, the Medicare Fairness for Organ Transplant Recipients Act of 2003) and Representative Cardin (H.R. 26, the Medicare Payment Restoration and Benefits Improvement Act of 2003).

An example will clarify the intent of this proposal. This recommendation refers to the patient who receives a liver at age 58, or a heart at age 23, and has insurance other than Medicare. Often, such recipients are able to return to work as a result of transplantation, and will then receive medical and prescription coverage through their employers. If a patient has other coverage for immunosuppressive medication, then that coverage should remain primary and Medicare coverage should be secondary, so that the burden on Medicare is not increased too greatly. This would follow the traditional pattern for coordination of benefits. During their years of employment, they will pay federal taxes and contribute to FICA. If, however, upon retirement or disability, Medicare becomes their primary insurer, then they may lose the ability to pay for transplant-related medications. As was stated above with respect to Recommendation 27, this could result in untoward harm to individuals, as well as a waste of donor organs.

Date Last Reviewed: