Advisory Committee on Organ Transplantation

Advisory Committee on Organ Transplantation (ACOT)
Fall Meeting
November 2–3, 2006

Doubletree Hotel
Bethesda, Maryland

Thursday, November 2

Welcome and Introductions

Gail Agrawal, Chair of ACOT
Remy Aronoff, Executive Secretary of ACOT

Mr. Aronoff welcomed the new Advisory Committee on Organ Transplantation (ACOT) members, and Ms. Agrawal led participants in a round of introductions.

Working Group Recommendations on Centers for Medicare and Medicaid Services (CMS) Reimbursement

Suzanne Conrad, Iowa Donor Network

Ms. Conrad reported for the work group on CMS reimbursement of organ procurement organizations (OPOs) for donation after cardiac death (DCD) and insurance coverage for living donors and presented the group's recommendations:

• Recommendation 1: When the next of kin has made the decision to pursue organ DCD, the CMS-designated OPO is responsible for expenses related to donation. ACOT recommends to the Secretary that the Medicare program allow these direct organ acquisition expenses to be reimbursable to the OPO under the Federal program. It would thereby remove a financial barrier to donation. Reimbursement to the OPO would begin at the time donation consent is given and continue until the time organs are recovered or the time a patient is returned to palliative care. At that time, responsibility for expenses would revert to the patient or the patient's insurance carrier.

Dr. Solomon asked if the reason the patient might be returned to palliative care would be because it was discovered that the operation could not proceed and, in this case, if it is fair to give the patient the expenses? The group discussed the fact that this is typical and that families are aware there is a chance that this will happen.

• The motion to adopt the recommendation was seconded; there was no further discussion on the recommendation. The vote was held and was unanimous.

Ms. Conrad read the second and third recommendations, which relate to coverage of those who are living donors:

• Recommendation 2: ACOT recommends to the Secretary that he promote collaboration between the transplant community and the insurance industry to adopt standards of coverage for living organ donors specifically relating to future adverse events (e.g., hernia repair, biliary tract reconstruction) resulting from the donation. The future coverage period would be limited to 10 years.
• Recommendation 3: ACOT recommends to the Secretary that he take action intended to provide Medicare eligibility for any living donor who loses insurability as a result of disability on the basis of previous organ donation.

Dr. Lorber asked about insurance portability and instances in which the complication occurs after the donor has changed insurance companies. Dr. Migliori stated that these liabilities go to the new carrier and, if the donor has problems getting insurance (or becomes unemployed or their employer goes out of business), the third recommendation would apply. He noted that it is rare for individuals to be denied insurance coverage because of their past donation. If all other commercial opportunities for coverage are denied, CMS would become the backup.

Dr. Vega asked if the work group considered a recommendation for instances in which living donors do not have insurance to cover pain medications postoperatively. Ms. Conrad responded that the work group did not address this situation; it appears that some centers pay and others do not. Dr. Migliori noted that the organ recipient's insurance is responsible for this and that at the time of discharge, the transplant center becomes responsible for this.

Mr. Hagman asked why the second recommendation contains the coverage limitation of 10 years, when donors are likely to need more coverage and have more problems as they age. Dr. Migliori noted that the work group had considered this limit for practical rather than other reasons. It was thought that the complications would primarily occur in the first year, but he conceded that the point is well taken. Mrs. Boone commented that she had also missed noticing the 10-year limit; she inquired about what would happen after that period was over. Dr. Migliori suggested that the recommendation be changed to recommend coverage be perpetual and remove the 10-year limitation.

Ms. Principe noted that the group appeared to be in agreement to take out the 10-year limitation. She asked about the awkwardness of potential donors having to submit a letter of denial from their insurance company. Dr. Migliori responded that such requirements would be developed under the standards created by the insurance company industry and associations such as the Health Insurers' Association of America, etc.

Ms. Agrawal accepted a motion to accept the recommendations, with an amendment to remove the 10-year limitation; the motion was seconded. There was no further discussion and the motion was unanimously accepted.

• FINAL RECOMMENDATIONS FOR RECOMMENDATIONS 2 and 3:
  
  Recommendation 2: ACOT recommends to the Secretary that he promote collaboration between the transplant community and the insurance industry to adopt standards of coverage for living organ donors specifically relating to future adverse events (e.g., hernia repair, biliary tract reconstruction) resulting from the donation.
  
  Recommendation 3: ACOT recommends to the Secretary that he take action intended to provide Medicare eligibility for any living donor who loses insurability as a result of disability on the basis of previous organ donation.

Working Group Recommendations on Public Solicitation of Donors

Dr. David Conti, Albany Medical Center

Dr. Conti presented the work group's recommendation:

• ACOT recommends that the Secretary of the Department of Health and Human Services (HHS) develop guidelines that intend to protect the ability of the Organ Procurement and Transplantation Network (OPTN) to continue to equitably allocate donor organs within a single national network and potential individual recipients from risks that can arise from public appeals (e.g., Internet Web sites, media campaigns, and billboard advertisements) for organ donors. These guidelines would serve as a resource for transplant centers, OPOs, and potential donors and recipients. ACOT further recommends that the guidelines take into account: (a) The distinction between deceased and living donors; (b) the necessity to ensure that money is not exchanged between donors and recipients; and (c) psychological motivations of donors resulting from public solicitation.

These recommendations grew out of the extensive discussions generated by the presentations at the last ACOT meeting in May and were conceived by the work group as guidelines, rather than as requirements. The goal is to help the public be aware of the risks and how to approach these risks, not to ban directed donations.

Ms. Agrawal suggested changing the word "money" to the phrase "valuable consideration" which is a phrase with legal meaning. Dr. Lorber asked if there is a common definition of "valuable consideration" and Ms. Agrawal reported that ACOT had discussed this question and made suggestions to the Secretary about clarifying the term. To date, ACOT's suggestions have not prompted action. Ms. Levine reminded the group that the Secretary is not authorized to issue his own definition but, to the extent that it is hard to develop this area without a definition, the Secretary can seek help from the Justice Department and/or Congress. She commented that ACOT can reiterate that this lack of a definition continues to cause problems, which might be helpful.

The work group was asked to clarify the phrase "public appeal for live organ donors." Dr. Conti said that a lot of work has been done over the last 20 years to develop equitable and fair methods of allocating deceased donations. The appeal of public calls for organs has the potential to destroy this system and result in allocation of organs to patients who may not benefit the most from the particular organ, in both directed deceased and live donor situations. The bottom line is that public solicitation is dangerous to the allocation system, especially since it fosters public mistrust of the existing system. Dr. Solomon noted, on the other hand, that no one wants to hamper creative public education efforts about donation-education of doctors, patients, and the public is extremely important. Ms. Principe suggested adding language to stress the need for educational campaigns. Ms. Agrawal suggested adding language to ACOT's recommendation that the Secretary promote an educational campaign to inform the public of the risks of circumventing the existing allocation system.

The group discussed the fact that ACOT would not make a recommendation that would prohibit speech or impinge upon the First Amendment. The Secretary cannot either violate the First Amendment by prohibiting speech or various State and Federal laws that permit designation of organ recipients by donors. Ms. Agrawal commented that it is allowable to have reasonable restrictions on misleading speech.

The group debated sound versus unsound public appeals and mechanisms for protecting the integrity of the existing allocation system rather than restricting directed donation. Mrs. Boone said that it's hard to distinguish between good and bad solicitation and that asking friends and family members to give an organ is also solicitation. She reminded the group that, when it comes to living donor solicitation, centers and surgeons are not providing long-term followup for the donors to help gather data that might inform a person's decision to donate.

Dr. Vega said that the present allocation system is designed to allow the equitable distribution of organs from deceased donors. For living donors, there is no system that protects equity in allocation. In fact, centers tell patients to seek a living donor, which complicates the situation. People need to understand the difference between public solicitation for live donation versus solicitation of deceased donors. Dr. Conti agreed, stating that many centers and patients are looking for guidelines for what to do in these instances, so that it would be good for the Secretary to develop such guidelines.

Ms. Agrawal summarized the discussion by stating that the group as a whole is not ready to act on the recommendation yet. The issues behind this single recommendation might be clearer if it were to be split into a series of recommendations arising from ACOT's concerns. She asked the work group to continue working on this issue and to bring it back at the May 2007 meeting. Dr. Burdick added that it would be helpful to have more information about how the transplant program should clearly address the situation. Committee members agreed to do so, and ACOT members with specific concerns were asked to provide them in writing to the work group members. Ms. Levine will assist the work group with legal issues.

Work Group on Medicare Part D

Kris Robinson, American Association of Kidney Patients

Ms. Robinson reported that the work group has no recommendations to present; members will monitor both Plan D and Plan B over the next few months to see what problems occur with implementation. The workgroup has talked with CMS about its concerns about organ recipients who are covered by these programs. A lot of the challenges are coming at the pharmacy level. The work group wants to aggregate the information that is available to assess the situation. The OPTN Transplant Administrators will be contacted to learn more from them about specific transplant patient and transplant program concerns regarding Medicare Part B and Part D.

Living Donor Bill of Rights

New business

Mrs. Boone informed the group about a new living donor Bill of Rights, of which she has copies for ACOT members. Ms. Donna Luebke, of Cleveland's Metro Health Medical Center, spoke to the group. She said that live donors are finding that insurers have a 7- or a 30-day benefit, after which time coverage ceases. For example, her group has a donor member who was told that complications were covered by the organ recipient's insurance only for 15 days. There are many cases in which the organ recipient's insurance policy refuses to pay for the donor's health care. A self-employed donor recently lost her company because she cannot get insurance coverage. With respect to the discussion about public solicitation, there is a very real fear that this situation will undermine both the living and deceased donor systems. The living donor Bill of Rights addresses actual issues that donors face.

Ms. Agrawal thanked Ms. Luebke for her remarks but said that this subject fits more appropriately under the "Public Comment" portion of the agenda. ACOT publishes its agenda publicly prior to its meetings and must be attentive to that written record so that members of the public can attend and hear what is on the agenda at any particular point. She promised that the group would return to this topic at the end of the day during the Public Comment period. Several ACOT members asked to see a copy of the document so they can discuss it after they have read it, and it was distributed to the group.

Issues Related to Tissue Regulation

Tracy Schmidt, Association of Organ Procurement Organizations (AOPO)
Patricia Aiken-O'Neill, Eye Bank Association of America (EBAA)
P. Robert Rigney, American Association of Tissue Banks (AATB)
William Zaloga, New York State Department of Health
Celia Witten, Food and Drug Administration (FDA)

Mr. Holtzman introduced the speakers to present on tissue regulation and gave an overview on the subject. He said that there is a connection between organ and tissue donation: When something untoward occurs concerning tissue in the United States, it affects organ donation rates as well. Negative publicity affects both areas. Many OPOs are also tissue recovery organizations and a large percentage of tissues recovered come from OPOs. There is, however, a lack of information about tissue and recovery in the United States. It is not clear what organizations are doing recovery, and it is relatively easy to enter the field, which is not well regulated (e.g., there are no mandatory guidelines). There appears to be a need to learn what entities are engaged in recovering tissues for transplantation and/or research. Ms. Agrawal stated that tissue banking and its regulation have been brought to ACOT's attention several times. While ACOT is specifically concerned with solid organs for transplantation, the public sees it all as the same field and area.

• Mr. Tracy Schmidt, President, AOPO

There are 58 OPOs in the United States. OPOs are interested in tissue recovery because these organizations are the gatekeepers for referrals for donations, and they also work on recovery as well, as the majority of tissues are recovered by OPOs. There is no centralized process or place for collecting data on this, however. Other than eyes, it appears that most tissue comes from OPOs. As noted, public trust issues affect both areas (organ and tissue); therefore, OPOs conduct much public and provider education on these issues. The AOPO had four recommendations for ACOT:

1. ACOT should encourage the establishment of an independent expert inquiry (e.g., by the Institute of Medicine) to assess the regulatory framework for both tissue and whole body donation. Such an inquiry would examine certification, accreditation, and what entities are currently in the field. The public is looking for organizations to protect them. Further, AOPO feels there is a need to limit recovery organizations to community-based organizations with nonprofit status, legally structured in such a way to support public trust. There is also a need to improve data collection on the national level, as there is currently no single source for data.
2. The FDA should have the role of requiring annual reporting of recovery activity (this could be Web-based reporting), and the establishment of industry-wide definitions—Mr. Schmidt noted that the definition of "tissue donor" is currently unclear and varies by location, which affects data collection. The goal would be to continue to improve the system to track the end-use of tissues.
3. CMS should use Hospital Medicare Conditions of Participation to ensure that hospitals and other OPOs are serving the public interest.
4. ACOT should seek public input on whole body donation programs for consideration by the whole committee. Some areas are having more problems than others and this feedback should be collected and considered.

Finally, Mr. Schmidt reported that AOPO is holding a summit meeting to include tissue processors, recovery agencies, AATB, AOPO, EBAA, and others. This meeting will be held on November 28, 2006, with the goal of improving public trust as an industry.

Questions and Discussion

Dr. Migliori asked, What proportion of tissue donations are managed by OPOs? Mr. Schmidt responded that about 80 percent of OPOs are doing tissue recovery work, although that is an estimate. Around 60–80 percent of all tissue recovered comes from OPOs. In terms of whether OPOs could do all of the tissue work and whether there is enough capacity, the answer is probably yes, although that would vary by locale.

Dr. Solomon asked what the actual and potential risks are that are important to prevent. Mr. Schmidt answered that public trust and public safety need to be enhanced. In terms of public perception about donation as a whole—either whole body or tissue—30 to 40 percent of the U.S. public has concerns and is not fully committed to the idea of donation. Mistrust is a problem. Fraud and abuse are additional problems. Consent used to be a problem, but that has gotten better.

• Patricia Aiken-O'Neill, President, EBAA

The EBAA was founded in 1961 and currently has 83 member banks. EBAA members provide 97 percent of all corneal tissue used in transplantation. Members conduct 46,000 sight-restoring transplants annually and assist with significant medical research advances. There has been no transmission of systemic infection through transplanted eye tissue since 1987.

The EBAA was the first transplant association to establish medical standards, in 1980. EBAA's accreditation program includes a comprehensive education and technical certification program (which is voluntary, but all eye banks comply). In terms of data collection, eye banks are required to conduct tissue tracking as part of their accreditation requirements. Both the FDA and EBAA require banks to report adverse reactions in eye banking through an online system. The last phase of the comprehensive regulatory system was put into place by the FDA in 2005. It includes registration requirements, donor eligibility regulations (this concerns screening and testing), good tissue practice (GTP), and inspection and enforcement procedures.

To ensure the protective effect of FDA regulation across organ, eye, and tissue communities, EBAA seeks regulatory harmony between CMS and FDA when donors are shared. Specifically, EBAA recommends regulations to:

1. Modify Medicare Conditions for Coverage for OPOs relative to data retention requirements;
2. Modify the standard on adverse event reporting as part of an OPO written policy; and
3. Include an eye bank and a tissue bank representative on an OPO's advisory board (currently there is just a tissue bank representative).

EBAA also recommends that:

1. The Government allow sufficient time for the FDA's recently implemented regulatory structure (last published in June 2005) to work and to be appropriately evaluated; and
2. The Secretary write to State Governors to consider the adoption of Section 17 of the Revised Uniform Anatomical Gift Act (UAGA) of 2006.

Finally, EBAA's message is that, as partners in this process, our responsibility is to protect the donation process, to be accountable to the public, and to celebrate the miracle of transplantation.

• P. Robert Rigney, Chief Executive Officer, AATB

AATB welcomes the opportunity to present to ACOT and would also welcome an opportunity to meet with the ACOT tissue regulation work group.

United Network for Organ Sharing (UNOS) data from 2005 indicate that there were about 14,500 organ donors, and about 25,000–30,000 tissue donors that year; 5,000 (or 20 percent) are both organ and tissue donors. There were 28,108 organs transplanted in 2005; over 1 million tissue transplants occur in the United States each year and more than 1.5 million allografts distributed. In the last 20 years, there have been 10 million tissue transplants, while the last case of a viral transmission—of hepatitis C virus (HCV)—was in 2002, during the window period. The only other cases of HCV transmission were in the 1990s; tuberculosis has not been transmitted in 50 years; the last HIV transmission was 20 years ago, also during a window period.

In March 2005, AATB began to require nucleic acid testing for both HIV and HCV. There have been instances of bacterial contamination, of clostridium, in 2001, in which one person died. From 1998–2004, 14 cases of clostridium occurred, all from the same bank. They have massively changed processes since then. One case of fungal contamination occurred, in 1997. There has never been a case of cancer transmission.

The AATB believes the field is heavily regulated. Federal statutes that apply include the National Organ Transplant Act and the Public Health Service Act; regulations include those promulgated by the FDA, which has regulated tissue banks since 1993. State regulations also apply to tissue banks: Every State has some form of regulation under the UAGA. Also, private accreditation occurs through AATB; AATB member banks provide the overwhelming majority of tissues (95 percent) used for transplantation.

AATB's mission is to facilitate the provision of safe transplantable tissues of uniform high quality in quantities sufficient to meet the national need. The organization has established universally accepted standards to prevent disease transmission and to ensure optimal clinical performance of transplanted tissues and cells. AATB also accredits tissue banks and trains and certifies tissue banking staff. Six States require all of their tissue banks to be AATB accredited.

AATB standards were first published in 1984 and are now in their 11th edition. These standards address all aspects of tissue banking, including records, informed consent, containers, standards of practice, recalls, etc. These standards are references in more than 20 State statutes or regulations. AATB's Standards Committee regularly liaisons with other agencies including the FDA, EBAA, Centers for Disease Control and Prevention (CDC), and many others. The American Academy of Orthopaedic Surgeons has as a policy to use only tissue from AATB-accredited banks. AATB standards have served as a model for the FDA's current GTP regulations, New York Department of Health's tissue and cell standards, the European Union's Commission Directives, and many others.

AATB has also issued guidances (and are developing new guidance documents) to help the field. Guidances are in development on subjects that include donor family services, tissue donor screening, communicating with medical examiners, and other topics. AATB has also engaged in several important collaborations including projects with CDC, the World Health Organization, the Canadian Standards Association, and the Canadian Council for Donation and Transplantation, etc.

Mr. Rigney discussed cases involving tissues and tissue regulations. There was a clostridium death in 2001 (the Lykins case). In this case, AATB's time limits on retrieval were not followed and the AATB-accredited tissue bank refused the donor tissue. A nonaccredited agency took the donor and used a nonaccredited processor. In a second case, that of Biomedical Tissue Service, medical records were falsified, and consent forged by a nonaccredited organization. An AATB-accredited bank discovered these problems and brought in the FDA. In the third case, Donor Referral Services, a nonaccredited company, falsified medical records. This was discovered by an AATB-accredited processing company.

The AATB responds quickly and effectively when these cases come up. The organization's view is that AATB accreditation and standards are critical to preventing problems. The cases concerned nonaccredited tissue banks that violated AATB standards. Changes are needed to prevent such problems from occurring again.

At the ACOT May meeting, Mike Seely presented to the group on oversight issues for tissue banks; Mr. Rigney disagrees with the material that was presented by Mr. Seely at that session. We concur that safety is paramount and AATB requires an enormous amount of screening and testing. Any problems in tissue banking have to be addressed by the entire transplant community, however, not solely the tissue community.

AATB makes the following recommendations to ACOT:

1. First, do no harm (we advise that ACOT spend more time gathering information before acting);
2. Enact Federal criminal sanctions that would make it a crime to falsify donor consents or to intentionally falsify donor records;
3. Urge the enactment of the 2006 UAGA;
4. Require AATB/EBAA accreditation of tissue banks (use Joint Commission on Accreditation of Healthcare Organizations [JCAHO] or deemed status models);
5. Explore data collection requirements such as annual reporting by registered facilities; and
6. Investigate oversight and regulation of whole body donation for medical education and research.

Questions

Mr. Holtzman asked how many agencies are recovering tissue, how many are accredited, and what barriers exist to entering the business. The response was that AATB accredits 97 percent of tissue banks, some of which are located in Canada. The FDA could probably give more information on this subject as well. Several OPOs are accredited: 19 OPOs are accredited to do tissue recovery, and several also are accredited for processing. There is no barrier to opening a tissue bank, except that the operator has to meet many significant requirements. The inspectors appear at the facility pretty quickly, and it is hard to find processors to work with if they are not in compliance with regulations and standards. There are multiple levels of controls: By the FDA and by State and private accreditation agencies. TBAA is not averse to Federal regulations.

Mr. Holtzman asked if an organization went into business and was approved whether the FDA becomes concerned about issues such as falsification if the bank is not accredited by AATB. Mr. Rigney responded that the FDA can probably answer this better; FDA does not have the authority to regulate consent: This is regulated at the State level under the UAGA in each State. However, AATB has extensive consent requirements and documentation requirements. Mr. Rigney clarified that TBAA has fewer standards on tissues for use in research settings, although they are trying to get more deeply involved with this subject. Most controversies have to do with nontransplantation uses.

Dr. Conti asked why there are any nonaccredited tissue banks in the first place. Mr. Rigney replied that TBAA cannot figure out why banks don't get accredited, but their best guess is that this is due to the amount of time it takes (about 9 months) and the number of inspections required. Some of the banks that only do one type of work with tissues (e.g., they just store or they just process) may not think it's worth it to go through the work required to be accredited. Banks must be reaccredited after 3 years.

• William Zaloga, Blood and Tissue Resources, New York Department of Health

Dr. Zaloga presented on New York State regulation of tissue banks. In 1990, the State amended its public health law to incorporate organs, tissues, and body parts. The State has broad authority to regulate any tissue from recovery to final use. A State Transplant Council exists, as well as technical advisory committees.

New York has a long regulatory history with respect to tissues, including the following regulations: Clinical Laboratory and Blood Banks (1965); Hematopoietic Progenitor Cell Banks (1988); Semen Banks (1989); Human Milk Banks (1990); Article 43-B, "Organ, Tissue and Body Parts Procurement and Storage" (1990); General Tissue Banking Standards (1991); Tissue-specific Technical Standards (1993); and Guidelines for Collection, Processing, and Storage of Cord Blood Stem Cells (1997).

There are significant challenges to regulations. There are multiple parties involved in a very complex process. There are issues of consent, donor qualification, recovery, processing, and transplantation. One donor may provide organs and tissues for multiple recipients. The technologies are dynamic. Finally, there is intense media scrutiny of issues not well understood by the public. Problems with regulation of facilities include inadequate consent process; processing deficiencies; failures to perform required testing; and unlicensed operation (rogue facilities).

New York State regulation requirements address licensing, director and medical director requirements, medical advisory committees, general technical standards, tissue-specific standards, and nontransplant tissue standards. Standards focus on donor selection and testing; donor and recipient consent; record keeping; labeling; processing; distribution; and quality improvement. New York has cradle-to-grave tracking of tissues. Technical standards address many tissues including cardiovascular, musculoskeletal, eye, skin, etc. They are very detailed and consistent with professional standards such as those of AATB. New York State employs surveyors who are technical experts in the field, who review the banks' applications, and who conduct onsite inspection for quality assurance processes.

New York has established administrative requirements for tissue banks, including the educational level and experience of the tissue bank director; that the medical director must be licensed in their State of practice; and that there be a medical advisory committee consisting of five members with expertise in the field, including infectious disease (and, for reproductive tissue banks, genetics). Tissue banks may apply for a special exemption from a specific standard in cases of medical emergency or special medical condition, or for a methodology unique to the processor.

To maintain the license, the bank must maintain compliance with applicable sections of Part 52 and Subpart 58-5, as determined by periodic onsite surveys; report errors and accidents to New York State Department of Health; submit annual activities reports; provide denominator data; file an annual application renewal; and report changes in its director, medical director and/or owner and followup with new application.

In terms of addressing the significant challenges associated with tissue banks, New York adopts the following solutions. Because multiple parties are involved, the State requires strict oversight through licensure. To address the dynamic nature of this technology, the State maintains an active role in revising its standards. To meet the wide media scrutiny of this field, the State works closely on public education efforts with the public affairs office. In order to ensure an adequate consent process, New York requires the processor to specify the types of tissue to be used, and for what purpose. In order to ensure there are no processing deficiencies, the State focuses on contamination testing, validating methods, quality assurance, etc. In terms of the role of the funeral home directors, New York is considering restrictions to their ability to recover tissues. To ensure that banks do not fail to provide required tests, New York's surveyors (who are experts in the field) consult with the banks. To prevent unlicensed operations, the State follows up to ensure compliance.

Questions

Ms. Conrad asked if the New York banks are inspected by both the FDA and the State. Mr. Zaloga responded that FDA regulations supplement, rather than inhibit, State regulations. Tissue banks have to comply with both sets of regulations. Mr. Frieson asked if the tissue banks are AATB certified. Some are; the ones that are not sometimes have deficiencies and need more help from the State to be in compliance. Ms. Conrad asked what the impact would be on State licensing and regulatory functions if AATB-certification was required for all tissue banks. Dr. Zaloga felt that New York's regulations parallel the AATB's and that the standards are very similar and complementary.

• Dr. Celia Witten, FDA; Office of Cellular, Tissue and Gene Therapies; Center for Biologics Evaluation and Research

Dr. Witten spoke about the FDA's regulation of human cells and tissues and cellular or tissue-based products (HCT/Ps). Centers with an interest in this field include: The Center for Biologics Evaluation and Research (vaccines, blood and blood products, human tissue/tissue products for transplantation, cells, and gene therapy); the Center for Drug Evaluation and Research (drugs, some biological); the Center for Devices and Radiological Health (devices for treatment, implants, and diagnostic devices); the Center for Veterinary Medicine; the Center for Food Safety and Applied Nutrition; and the National Center for Toxicological Research.

The history of the FDA's engagement is one focused on infectious disease prevention. In 1993, the FDA regulated human tissue intended for transplantation (interim final rule: 21 CFR part 1270; final rule published in 1997). In 1997, the FDA announced a proposed, risk-based approach to all HCT/Ps. From 1997–2004, the FDA published three proposed rules; all final rules became effective May 25, 2005 and codified as 21 CFR part 1271.

21 CFR Part 1271 is a platform for regulation of all human cell and tissue products, defined as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer to a human recipient. (Tissues for educational and nonclinical research are not covered by the regulations.) For certain HCT/Ps ("361 HCT/Ps"), part 1271 is the sole regulatory requirement. For HCT/Ps also regulated as drugs, devices, and/or biological products, part 1271 supplements other existing requirements.

Included are reproductive cells and tissue (e.g., semen, oocytes, and embryos); hematopoietic stem cells from peripheral blood and cord blood; cellular therapies (e.g., chondrocytes and islet cells); musculoskeletal tissue (e.g., bone, ligament, and tendon); skin; ocular tissue (e.g., cornea and sclera); human heart valves; and human dura mater. Not included are: Tissue/device and other combination therapies; vascularized organs (Health Resources and Services Administration [HRSA] has oversight); minimally manipulated bone marrow (HRSA has oversight); tissues intended for educational or nonclinical research use (not intended for transplantation); xenografts; blood products; secreted or extracted products (e.g., human milk, collagen, and cell factors); ancillary products used in manufacture; and in vitro diagnostic products.

Dr. Witten described the FDA provisions and regulations and the content of specific subparts. Subpart A explains what is regulated and what needs premarket review. Subpart B describes who needs to register, how to do that, and what information has to be provided. Subpart C describes donor eligibility, screening, testing, and exceptions, as well as relevant communicable disease agents and criteria for adding new ones. Subpart D describes current GTP—methods, facilities, and manufacturing controls to prevent communicable disease transmission—and lists many topics in GTP of the rule such as procedures, records, and tracking. Subpart E gives additional requirements reporting and labeling. Subpart F describes the FDA authority for inspection and enforcement. In addition, guidances are available from the FDA to aid in implementation of these regulations.

Questions

Ms. Agrawal asked if the FDA has any regulations on patient consent, and the answer was no. Dr. Migliori asked if people must use FDA-approved centers, in other words, if there was any way to avoid FDA oversight. Dr. Witten replied that you cannot distribute anything that's not approved. Mr. Holtzman asked if the FDA has a good handle on everyone who is recovering tissues in the United States. The response was that if someone is recovering tissue for something other than transplantation, they are not covered by the FDA. Second, in terms of the universe of facilities that are recovering tissues, the FDA only knows who reports to it and is on the FDA list; there may be entities that are not on the list. Third, in terms of whether the FDA knows about their operations, they are looking at this on both the recovery side and also with respect to implementation of the recent rules.

Dr. Vega asked why the FDA cannot require that any company involved in tissue for transplantation must be certified by AATB or another such body. Dr. Witten commented that this concept comes up often. The answer is that there is an issue of outside influence and conflict of interest. There is a legal line, which has to do with a group such as AATB being or not being an outside group, and how independent the groups are. Dr. Conti asked about a recent case in which tissue was processed by a facility that was not accredited by AATB and asked if the facility had been approved by the FDA. Dr. Witten said that she cannot comment on a situation that is under investigation.

Ms. Conrad said that it's encouraging to hear that there are questions about implementation of the rule. One needed change is to address the case of facilities that have two locations that are under two different FDA offices—they are subject to two inspections at any time and this is very burdensome.

Entertainment (Mis)education: Findings From a 2-Year Media Monitoring Study

Dr. Susan Morgan, Purdue University

Dr. Morgan noted that ACOT's mission is to increase public confidence and assure the public that the system is equitable. One barrier to these goals is the media: Negative portrayals of organ donations affect the public's willingness to donate. To understand the role of the media, the Division of Organ Transplantation (DOT) provided funding to monitor the major networks and news channels for coverage of organ donation and the allocation system. The subject comes up quite frequently; on average, it appeared every 8 days just on the four major channels examined in 2004–2005. Thirty entertainment shows included story lines or subplots about organ transplantation, not including news programming, late-night television, or cable.

In a prior research study, family members who oppose donation cited the entertainment media (not the news) as the source of their negative views. Some nondonors use the negative media content to justify their not donating. They feel that the media fiction (such as the existence of a black market for organs) must be based on some kernel of truth; entertainment media thus reflects the public's worst fears about organ donation. This happens because the shows use accurate medical terminology, so viewers believe that everything else is accurate too. Many entertainment shows are based on real stories drawn from the news media, which also leads viewers to assume that all of the content is based on fact. In addition, there are few other sources for information about organ donation to counteract these views that, because of syndication and repetition, are seen over and over again by the viewing public.

It's important to remember how people cognitively process stories (including entertainment media stories). Magnetic resonance imaging demonstrates several facts: That stories are easy to remember; viewers suspend disbelief while hearing them; and that people forget the source of the stories (they can't remember that they learned something from a fictional show rather than the news). Also, when people watch television, they have the feeling they have seen it for themselves, and lived it vicariously; the more "into" a story someone is, the more factual the information seems to them. Specific myths often have to do with the black market, misperceptions about brain death, and fears about the inequality of the allocation system.

Public opinion studies reveal that 50–80 percent of people surveyed believe that there is a black market for organs in the United States. In fact, there are so many story lines about black markets, some of which last for a long time, that it's hard to set limits on which ones to look at. Dr. Morgan showed clips on this subject from One Life to Live, Crossing Jordan, and Boston Legal.

Fifty percent of people believe that one can recover from brain death, so why donate the organs if you might wake up otherwise. Dr. Morgan showed clips from Grey's Anatomy in which someone who has been declared brain dead later woke up.

Seventy-five percent of people believe that the medical/organ allocation is untrustworthy and unfair. Dr. Morgan showed clips on this subject from The Simpsons, Grey's Anatomy, and The Unit. Fourteen percent of people from one survey reported that they fear doctors will take their organs before they are dead. Dr. Morgan showed a clip from Grey's Anatomy on someone waking. People are also worried about being "cut up," which might reflect concerns about bodily integrity and the coldness of the medical system. Dr. Morgan showed a clip from Grey's Anatomy.

There are accurate portrayals in the entertainment media, also, although not many. Through the nonprofit contractor Hollywood, Health & Society, transplantation professionals, and the media work together to try to ensure more accurate portrayals. Examples of shows with more accurate and/or positive portrayals include Num3ers and Scrubs. (Clips were shown from these shows with more realistic portrayals of the organ transplantation process.) Such efforts to work with scriptwriters are important to improve what the public sees on this subject. This can help counteract the connection between messages and stories from television and people's preexisting fears about organ donations.

The way that the media presents organ donation has an impact on public attitudes about organ donation. It's important to remember that viewers suspend their critical thinking when they are engaged in the story-telling process so, if no counterarguments are seen by them in other places, damage can be done. People need to know that brain death is different from being in a coma; they need to know that the allocation system does not give preference to one group of people over another.

Recommendations:

• Advocacy: Through a contract award, DOT has funded Hollywood, Health & Society to educate writers and producers on this issue.
• Activism: There is a huge group of professionals and recipients who care about this issue (including the 93,000 people on the list) who can be mobilized to speak out against inaccurate depictions. We should use the experience of the AIDS and breast cancer activists who waged efforts against inaccurate stories.
• Attention: We need to pay attention to this issue and reach out to shows and writers who need more education on this subject.

Questions

Dr. Conti remarked that the findings are stunning, especially with the shortage of organs that is occurring. He asked about specifics on how the HIV/AIDS and breast cancer communities' activism worked. Dr. Morgan said that it was basically a lot of angry people speaking out. Gay activists particularly used their unofficial contacts inside the industry to influence the stories and generate opposition against feeding public fears about HIV/AIDS. The bottom line is that writers don't want to generate a huge, angry response because it hurts them in the long run and brings the producers' and executives' attention to a particular show.

Dr. Scantlebury asked about the percentage of writers who are interested in being educated. HRSA staff noted that more and more groups are calling for help on this issue. For example, ER is talking with staff today. Screenwriters call Hollywood, Health & Society, which then calls a participating entity responsible for providing more information, which could be an organization like CDC, HRSA, the National Cancer Institute, or someone from an individual transplant program.

Dr. Morgan commented that stories about problems connected to tissue transplant seem to be driving an increase in entertainment coverage of transplantation as a whole.

Recently story lines have appeared on Nip, Tuck; Boston Legal; The Simpsons; Veronica Mars; and others. It has spread to being included in shows other than crime and medical shows. Because no one is objecting, the stories are getting worse.

Larry Hagman described his experience being on Nip, Tuck and the plot of the current storyline. He said that his character dies, and his wife comes and takes the character's kidney.

Dr. Morgan added that viewers' responses about organ donations tracked with the content of the episodes that were being tested: The viewers report back as fact what was included in the show (that the allocation system is broken, that there is a black market or, more positively, that more people need to sign up as donors).

Dr. Solomon said, in thinking about how we can use activism to change this situation, we should consider how to capitalize on those who are on the list or have received a transplant or are families of recipients. We are organized as a system, but not as advocates. Dr. Morgan said that the first step is to educate and inform the providers and the professional community: People do not know that this is a problem. She is also working with Transplant Recipients International and other groups, and people seem interested in getting involved. It would be beneficial if OPOs and coordinators were to get involved in this and disseminate information to people on the list.

Dr. Scantlebury commented that DOT should look at this issue and put some funding behind it. We need to get the correct information back onto television and look at having spokespersons and public relations outreach. It was noted, however, that studies on coverage of mental health issues have found that a public relation or public education message inserted into a show with that content does not make much of a difference in perception. The way the brain interprets stories makes it important to insert the messages into the story line itself. Until the media is motivated to not ignore the accurate information, they will do so in favor of an exciting storyline. This is a business, but we should be clear that they should not make a profit at the expense of people's lives. We can be more proactive about this.

UNOS Department of Evaluation and Quality Activities Update

Deanna Sampson, Department of Evaluation and Quality, UNOS
Walter Graham, Executive Director, UNOS

Ms. Sampson spoke about OPTN membership standards, policy compliance, and enforcement. As everyone knows, there are not enough organs, so UNOS ensures that patients are appropriately listed and that organs are appropriately allocated. UNOS' contract with HRSA requires the existence of survey instruments, a peer review process, and data systems to conduct ongoing and periodic reviews of each transplant center and OPO to verify their compliance with the final rule and with OPTN policies.

In terms of the allocation analysis, 100 percent of allocations are reviewed, as are all member complaints and self-referrals. When it appears that there is a potential violation, UNOS gathers data, conducts a written inquiry, verifies responses with onsite visits, and takes the information to the review committee Membership and Professional Standards Committee (MPSC). The main potential problem areas are (1) that the recipient was not on a match run, (2) that the organ was offered and rescinded, or (3) that an out-of-sequence allocation occurred.

In 2005, 21,000 allocations were reviewed—1,084 inquiries were sent; 674 member self-referrals and 356 organ center referrals were investigated; 21 member complaints were explored; and 5 emergent issues identified. UNOS conducts field audits of each heart, lung, and liver program, each OPO, and other members as necessary. When UNOS goes onsite to a transplant center, staff examines candidates' medical records, data submission, data completeness, and patient notification. They verify that ABO typing was done twice prior to listing, and that ABO verification occurred prior to the transplantation. They also look at vessel recovery and storage.

Onsite work is divided into two score cards: (1) A clinical scorecard that looks at the accuracy of candidate listing status, ABO typing, ABO verification prior to implantation and (2) an administrative scorecard that looks at medical records being available for review, data entry errors, patient notification, and removal of candidates from the list. From 2000–2005, for liver programs across the country, compliance on the administrative scorecard was 89 percent and 95 percent for the clinical scorecard. For heart programs, compliance on the administrative scorecard was 90 percent and 94 percent for the clinical scorecard.

OPO reviews are conducted for consent for donation, ABO determination, serology testing, pronouncement of death, data submission, and accuracy. Site visits have been conducted for all OPOs and UNOS is developing scorecards for OPOs right now.

There were 109 referrals from the Policy Compliance Subcommittee to MPSC from July 1, 2005, to May 31, 2006. The referrals came from site survey results, member complaints, organ committee referrals, data submission, ABO discrepancies, allocation analysis, and metrics-driven findings. The actions taken on these cases during the due process period included deeming the facility to be a member not in good standing (7 cases); placing it on probation (3 cases); or sending a letter of warning, admonition, or reprimand (10 cases). Final action in these cases included removal of designated status to receive organs (two cases); deeming the facility to be a member not in good standing (one case); placing it on probation (one case); or sending a letter of warning, admonition, or reprimand (two cases). The committee also continues monitoring and may reaudit or conduct another site visit.

UNOS also conducts a metrics analysis to help identify any problems at a center or an OPO. This analysis looks for problems before a site visit occurs. There are about 20 metrics that serve as indicators that might suggest possible violations that need to be examined. The metrics for the waitlist are: Metric 1—modification or disparity in ABO; Metric 2—percent of heart 1A(e) and (d) greater than 14 days; Metric 3—total status 1A heart days; Metric 4—percent of liver status 1A; Metric 5—total status 1A liver days; Metric 6—M/P analyses; Metric 7—percent of patients at downgraded score; Metric 8—consecutive turndowns; and Metric 9—inactive programs with active patients.

Allocation metrics are: Metric 10—accepted for 1 patient, transplanted into another; Metric 11—allocations to candidates not on MR; Metric 12—percentage out of sequence placements; Metric 13—payback debts; Metric 14—0MM; and Metric 15—PTR code and data entry. Other metrics include: Metric 16—early deaths; Metric; 17—intraoperative deaths; Metric 18—graft and patient survival; Metric 19—percentage relistings; and Metric 20—data submission.

To date, the metrics have prompted 347 subcommittee reviews from July 1, 2005, through May 31, 2006. Of these, the recommended action was to place the facility on probation (1 case), have the facility voluntarily deactivated (3 cases); and continue to monitor the facility (128 cases).

Walter Graham, the Executive Director of UNOS, spoke about policy compliance and the future of enforcement. For a facility to come off probation, it must pass unscheduled, onsite visits, submit additional evidence, and pass additional audits. The harshest outcome is to be deemed a "member not in good standing." In these cases, public notice is given, in writing to the Secretary, OPTN members, and current and past patients. These personnel may not participate in OPTN work as officers, board members, or committee members. Those in violation of Section 1138 of the Social Security Act can have their privileges suspended, cease receiving Medicare funds for any service (e.g., beyond transplants), and be prohibited from receiving organs or listing patients on the OPTN waiting list. In the last year, two hospital programs have lost their status.

Due process steps are taken unless there is imminent threat to the quality of patient care. In all other cases, steps include interview and a hearing. A formal report including a transcript is produced and the member can appeal the decision. When a member is on probation or deemed to be not in good standing, it has to fully comply with OPTN requirements to be reinstated. The board restores membership; but if the Secretary was the initiator, the board cannot affect the decision.

All members that have been part of such actions have complied with ongoing monitoring Major changes have occurred because of the system. Sites have changed their leadership and personnel. In two hospitals, the CEOs were fired. Programs have been restructured and policy recommendations implemented. Experts have come in to help the sites solve their problems, for example, by restructuring the medical records office.

The MPSC process has resulted in 115 programs closing and withdrawing from the OPTN; these were facilities that were not able to correct the identified problems. Many people do not know that this has happened, because it's been very discreet; but there is aggressive monitoring of the system. In the future, changes will be made that will include helping patients and personnel report problems to the OPTN more quickly, such as through a patient call-in line, an e-mail address that can be used to report problems, and a confidential hotline for personnel.

Proposed bylaws changes for compliance that will likely be approved in December include: Increased surgeon/physician coverage; categorization of violations; changed evaluation of performance by looking at organ acceptance rates and waitlist deaths; referring doctors to local peer reviews by members; providing notice to OPTN of reviews and adverse actions by CMS, JCAHO, State agencies and vice versa, to improve communication; and reimbursement to the OPTN of costs over $500 for violations on the part of members.

More ideas include ways to let patients know there is a problem. The OPTN is beginning to discuss with DOT how to better alert patients. More patient education efforts are needed about what is available to them in terms of data and survival rates. The OPTN is sending patients information when they get onto the lists. We want more training programs, which might become mandatory. We want to add to the early warning metrics so that we can identify problems before they get too bad.

Questions

Dr. Migliori noted that the process described by UNOS makes transplant quality something that is unmatched elsewhere in American medicine. It's very transparent and a good way to educate people about the system and the protections contained within it. It will enhance confidence, as we make referrals that patients will receive the best care possible from the best source. He noted that the National Transportation Safety Board (NTSB) does this kind of quality assurance well, in terms of flight safety, and offers good models. Mr. Graham responded that the Chair of the NTSB is a former UNOS employee, so there are good linkages with that agency.

Mr. Frieson asked about the "hook patient," that is where a kidney comes in to the center, but isn't well suited for transplant. The answer was that the OPTN looks at every matched run sequence, where the allocation occurred, and the turn down reasons. There are cases in which the patient gets the offer but then someone else gets transplanted. However, the intended patient is not always able to receive the organ, in which case it would be offered to another patient.

Mr. Frieson asked about status 1A patients who seem to stay on the list forever. This is a metric that UNOS checks; there was such a case a few years ago, of someone who was on the list for a long time. The OPTN can look at programs and see how long a person stays on an urgent status listing and ask for explanation of what is happening with those patients. There have been instances where the OPTN has identified violations-one center is on probation; another one closed their program, fired their staff, and transferred all of their patients to another program.

Mr. Hagman commented that he had had that exact experience. A hospital in Los Angeles closed but he had not received any prior notice in advance of the closure. Patients were scrambling to find new places for both transplantation and followup. The OPTN staff responded that, in that instance, the OPTN was on the phone with the hospital CEO and suggested that the hospital announce the pending closure to the public, but it got leaked before that could happen. The OPTN had taken action against that program because of systemic problems and the Secretary closed them down for good. Their liver program wasn't participating in the compliance process and there had been misallocation, followed by a falsification of medical records and false information provided to the OPTN and the patient. A whistleblower revealed the problems to the OPTN and legal actions have occurred because of this.

Mrs. Boone suggested that information packets be provided to both patients on the waitlist and living donors. Mr. Graham committed to provide this information for living donors. He noted that, at most recent living donor committee meeting, there was a presentation about an outside organization offering a registry in four hospitals that have had good experience with both followup and self-reporting of data from donors. The OPTN is committed to finding a solution to this need. Dr. Migliori agreed that it is important to consider living donor outcomes, which are important to know in order for people to truly make informed choices. He urged the OPTN to consider building quality assurance outcomes data for living donors so this factor is also attended to.

Ms. Principe commented that cultural diversity is a factor and that it's important to be careful about how people perceive concepts and information. She urged the OPTN to look at this with deliberation. Mr. Graham agreed that patient education materials are most informative when they are created in the target language rather than being translated. Mr. Graham also noted that the OPTN has a relationship with the Virginia Commonwealth University's language department to help the hotline when needed.

New Science in Organ Transplantation

Dr. Kenneth Chavin, Medical University of South Carolina

Dr. Kenneth Chavin presented on new science in transplantation. We are now in a world where facial transplants are possible; there is now a registry with 18 hand transplant patients, which is an operation that was first conducted in 1998. He noted that immunosuppression to prevent rejection is very important in these cases There have been six cases in which patients lost their transplanted hands when they failed to take their immunosuppression medications. Nerve regeneration in these cases is still poor, but motor function is better than it is with a prosthesis. Nonetheless, social and psychological concerns about well-being still remain for these patients. Now we do not worry about how to do transplants, but how to optimize them; we are in the phase of making a good thing better.

Composite transplant has not had an impact on patient survival; graft survival is acceptable in compliant patients. While unparalleled research potential exists in this area, Dr. Chavin knows of only one research grant that is funding it. There is greater support for clinical research, including much funding from NIH and other Federal grant support. Grant support for clinical research includes the tolerance network, the living donor network for liver transplant, diagnosing rejection, and the Organ Donation Breakthrough Collaborative.

The collaborative has resulted in an increase in the number of organs available; it's working and more organs are being donated. The question is what kind of organs are they, and how we can make these organs last longer. If we look at different categories of standard criteria donor (SCD), DCD, and extended criteria donor (ECD), we can see that in all groups have increased their numbers. However, the question remains whether we have increased the number of good donors or reduced the incidence of delayed graft function. Ultimately, ECD has highest delayed graft function, then DCD and SCD. We need good kidneys that function well, and not all of them are going to. We have to figure out which ones are best.

In terms of DCD liver donations, the numbers are going up and coming from older donors. Where liver cells are not working as well, graft survival is lower for DCD, compared to ECD donors. The livers are not equivalent. We are transplanting more people, but some of the organs are not the same quality. Use of ECD and DCD organs is disseminating rapidly, but the science of this area needs to continue to be studied. There is a higher risk and the question is whether it is acceptable.

In terms of living donation, data from the Dutch Transplant Foundation shows that it has a 50-percent efficacy. It's an easy solution for a cross-match positive. When we think about living liver donations, however, we must remember that it's a big trauma for the donor. It's a serious operation. We need to think about who is most appropriate to be conducting the operations. The Adult to Adult Living Donor Liver Transplant Cohort Study (sponsored by HRSA, the National Institute of Diabetes and Digestive and Kidney Diseases, and the American Society of Transplantation Surgeons found that the number of cases a hospital performs is crucial to patient survival. If a hospital does more than 20, they do much better (better even than with DCD). There is a learning curve.

There is also new immunosuppressant news from the World Congress. For example, steroid withdrawal programs are coming along, generated by the need to get people off immunosuppressants. For costimulate blockade with belatacept, death with loss of graft is now less at 1 year, which is headway.

In the kidney world, if we can prolong kidneys longer, the patient does not have to go back on dialysis or get a new kidney transplant, so it helps even more people. With new chronic allograph nephropathy, patients improve. Long-term results from the University of California at San Francisco show that, globally, people do well with this regime. Costimulation blockade has been tested in Phase II and it is clearly efficacious. In addition, there is a new way to administer cyclosporine-inhaled cyclosporine. Aerosolized cyclosporine is helpful and increases the number of years patients go without complications.

Then, on biomarkers: We are using genomics and proteomics as a replacement tool. There are new markers for urine samples for kidney recipients and it is possible to use FOX03 relative to the proteins. Finally, on T cells: As we apply multiple molecules to T cells, we can better see potential rejections. This will help us detect rejections, and fewer rejections are good for everyone.

Questions

Mr. Holtzman said that it's estimated that 20 percent of adult livers can be split; given that 15 percent of those on the waiting list are pediatric recipients, why not require the livers to be split and get rid of all of the pediatric cases on the waiting list? Dr. Chavin said that, actually, the policy has changed so that now children do get preference, although it depends if they are at a center that does splits and where the donor is. Dr. Lorber said that his recollection is that the mortality among pediatric cases waiting for livers is very low.

Dr. Leffel asked if genomic markers are going to be applicable to other solid transplants. Dr. Chavin noted that the turn-around time for this analysis takes several days, so it is currently too long. If it can be reduced down to a few hours, then we can use markers and can develop organ-specific markers.

General Accounting Office (GAO) and Inspector General Studies

Dr. James Burdick, Director, DOT

Dr. Burdick updated ACOT on several items. The collaborative has been successful in increasing the number of donors and transplants. There is a concern that the transplant programs are not being as effective as they could be at using the new "abundance" of organs. He wants to emphasize that the collaborative's message is one of action and we want the field to be focused on action.

The GAO is looking into the problem of noncompliant programs; they have met with the DOT and have begun their study. The Inspector General may come in, as well. The GAO is also studying pediatric immunosuppressants; HRSA and CMS will both be involved in this.

On the subject of the media, Dr. Burdick reported that he had just spoken with writers from ER about liver donation; they were interested in getting it as right as possible. Most of the contacts that are part of the Hollywood, Health & Society group are situations where the screenwriters approach us, rather than the other way around. We are also working with the OPOs to conduct public events/education in conjunction with programming that occurs as a result of these efforts.

Finally, ACOT members viewed a preliminary version of a movie celebrating the anniversary of organ transplantation.

Public Comment Period

• Donna Luebke: She is a Nurse Practitioner from Cleveland, OH associated with Metro Health Medical Center. She is also a living donor and advocate, as well as an educator. As discussed earlier, we have drafted a Living Donor Bill of Rights. It outlines issues that living donors face and what their care should look like. People self-refer and professionals refer patients to us. When a donor has a complication that is not addressed in postoperative period, or they have insurance problems, that's when they come to us. We work with centers to help the donors.

The meeting adjourned at 4:15 p.m.