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Organ
Procurement and Transplantation Oversight:
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER G--STANDARDS AND CERTIFICATION
Title 42: Public Health
CONDITIONS OF PARTICIPATION FOR HOSPITALS C—Basic Hospital Functions
(a) Standard: Organ procurement responsibilities. The hospital must have and implement written protocols that:
(1) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose;
(2) Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;
(3) Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes or to decline to donate. The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;
(4) Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;
(5) Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.
(b) Standard: Organ transplantation responsibilities. (1) A hospital in which organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term “rules of the OPTN” means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the PHS Act which are enforceable under 42 CFR 121.10. No hospital is considered to be out of compliance with section 1138(a)(1)(B) of the Act, or with the requirements of this paragraph, unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the hospital from the OPTN and has notified the hospital in writing.
(2) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, or pancreas.
(3) If a hospital performs any type of transplants, it must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide such data directly to the Department when requested by the Secretary.
[63 FR 33875, June 22, 1998]
also:
from since removed page: http://assembly.ca.gov/acs/committee/c10/hearings/Hospital%20Transplant%20Briefing%20Paper.doc
Organ
Procurement and Transplantation Oversight:
Who is
looking out for patients?
August
15, 2006,
1:30 – 4:30 p.m.
State Capitol, Room 4202
Purpose
This hearing will examine organ procurement and transplantation oversight. In the past several years, there have been growing problems with hospital transplant programs in California. These problems include shortages of medical and administrative staff, a shortage in the availability of organs, low transplantation volumes, lapses in leadership and oversight, ethical breaches resulting in improper transplants, and poor patient survival rates. Recent relevant newspaper articles are summarized below. The hearing has been organized to answer the following questions: What organizations are involved and how does the process work? Which government agencies are responsible for oversight of organ transplant centers? How are these centers managed? Are the problems unique to California? What are the causes of the problems? What are the medical and ethical issues associated with organ procurement and transplantation? Is there a need for stronger state regulation, monitoring and enforcement?
Recent Press Articles
· July 2006: The Los Angeles Times (LA Times) reported that the liver program at University of Southern California (USC) University Hospital (owned by Tenet Healthcare Corporation and managed by USC School of Medicine) in Los Angeles has one of the highest death rates in the nation, with twice as many patients as expected dying after their surgeries. The survival rate at USC's liver center, the third-largest program in the state, has steadily dropped since 2002, and hit a low of 75.8%. USC performed three times as many liver transplants in 2005 as St.Vincent Medical Center and the University of California, Irvine (UCI) combined in the recent years. According to Dr. Rick Selby, the program director, USC's numbers suffered because of a higher number of extremely ill patients who also suffered from kidney failure. However, the article indicates that Loma Linda University Medical Center's program treats a much higher proportion of very sick patients than USC and had a survival rate of 98%.
· June 2006: The LA Times reported that 20% of the 236 transplant centers across the nation failed to meet minimum standards for patient survival or performed too few operations to ensure competency. When these programs fall short of meeting Medicare guidelines, Medicare rules mandate no sanction, but require that the programs turn themselves in. The
· federal Centers for Medicare and Medicaid Services (CMS) has the authority to pull certification for funding from these centers but rarely does.
· June 2006: The LA Times also reported that geographic inequity is inherent in the U.S. transplant system. The U.S. is divided into 58 territories, each with its own supply of organs and separate waiting list. California is divided into four territories, each managed by an Organ Procurement Organization (OPO). To protect local access to organs, most donated within a territory go to patients waiting there, even if sicker patients are waiting elsewhere. This design has led to significant disparities, because supply and demand are not evenly spread across the country or the state. In large metropolitan areas, disease rates are higher which increase the need for organs, but donor recruitment is difficult. At the same time, transplant centers in less crowded territories are often choosier about who is placed on their waiting list. In California, waiting times for organs vary significantly between small geographic distances depending on what OPO waiting list the patient is on. The article also reports that it is feasible to have another system in which organs are regularly moved across territory lines to the sickest patients, given advances in transportation technology. For instance, when stored in ice-cold preservation solution, livers suffer no significant damage in the first 12 hours after harvesting. However, current legislation and regulation does not force organ-rich territories to share and, as a result, “the system has evolved into a collection of self-interested fiefdoms.” For example, the longest lines for livers nationally are in the territories surrounding New York, Los Angeles and San Francisco, which together account for 30% of all patients waiting for livers nationwide. The article stated that fewer than 2% of patients are savvy or wealthy enough to leave town and join waiting lists in other territories.
· May 2006: The LA Times reported that Kaiser Permanente Northern California During its first full year of operation in 2005, Kaiser performed 56 transplants, but twice that many people on the waiting list died. The LA Times article also stated that in 2004 Kaiser told more than 1,500 patients on the kidney transplant waiting list in northern California that it would no longer pay for treatment at contracting hospitals outside of Kaiser. Other problems cited were paperwork errors, doctors and administrators providing misleading and inaccurate information, poor notification to patients, and delays and problems associated with the transfers. The LA Times reported in a follow-up article in August 2006 that Kaiser Permanente is in the process of closing their kidney transplant center, but transfer of patients from Kaiser to University of California, Davis (UC Davis) and University of California, San Francisco (UCSF) will not be completed until the end of 2006. "endangered patients" awaiting kidney transplants by "forcing them into a fledgling program unprepared to handle the caseload."
· December 2005: The LA Times reported that St. Vincent Medical Center had a "higher-than-expected" mortality rate between January 2002 and June 2004 among patients in its kidney transplant program, prompting insurers (Aetna and Humana) to stop sending kidney transplant patients to the hospital. According to the LA Times, 36 patients died within one year of surgery during that period – 15 more than would normally have been expected. Data reported by the Scientific Registry of Transplant Recipients (SRTR), the federal contractor with responsibility to track and report organ procurement and transplant data, also indicated that 25% of the kidneys accepted for transplant in 2004 at St. Vincent were of marginal quality and had been refused by other transplant programs.
· November 2005: The LA Times reported that 32 patients at UCI Medical Center died awaiting liver transplants after the hospital turned down viable organs due to staffing shortages. The transplant program closed and later was found to have had inadequate staff training, poor monitoring of transplant patients, and irregular reviews of patient care. In addition the center had a 69% rate of patient survival compared to the Medicare guidelines which require a minimum survival rate of 77% for payment.
·
September
2005:
The LA Times reported that
the Medical Board of California launched an investigation of the liver
transplant program directors at St.
Vincent Medical Center in Los Angeles after reports that a
patient (a Saudi
national) who was 52nd on a regional transplant
waiting list received
a misappropriated liver ahead of other patients who were much higher on
the
waiting list. The
Royal Embassy of Saudi
Arabia paid St. Vincent $339,000 for the transplant and hospital stay,
which is
about 25 to 30% more than what insurance or U.S. government programs
would have
paid. St. Vincent’s
staff was found to
have falsified documents concealing the improper transplant. According to SRTR data,
St. Vincent allocated
about 8% of its donated livers to foreign nationals since the program
was
created in 1995, higher than the 5% guideline set by the United Network
for
Organ Sharing (UNOS), the federal contractor which administers the
nation’s Organ
Procurement and Transplantation Network (OPTN).
While the article points out that 8% of livers were allocated to foreign
nationals, St. Vincent indicates that it
has allocated fewer than 5% of all
organs received to foreign
nationals. UNOS
policies do not
specify punishments for exceeding its guidelines.
· March 2005: The Sacramento Bee reported that health insurers began declining to cover heart transplants at Sutter Memorial Hospital because of low program volumes. Insurers terminate small transplant programs based on the hypothesis that "the more [procedures] you do, the better you do it, so they [insurers] use a minimum volume requirement and an outcome requirement." In a follow-up story, the LA Times reported in November 2005 that the California Department of Health Services (DHS) had revoked Sutter Memorial's certification to perform heart transplants.
· May 2003: The San Francisco Chronicle reported that the California Pacific Medical Center halted its heart transplant program due to a shortage of surgeons, requiring over 30 patients on the facility's transplant list to seek transplants elsewhere.
Organ Transplant Statistics
According to the official U.S. Government web site for organ and tissue donation and transplantation, http://www.organdonor.gov/index.html, on average 74 patients receive organ transplants daily in the U.S. However, 18 patients die each day waiting for transplants. In 2005, a total of 28,107 transplants were conducted in the U.S., of which 3,243, or 11.5%, were done in California. Although the number of surgeries has grown steadily since 1988, a total of 92,544 patients across the nation are still waiting for organs as of August 9, 2006. Of these patients on the national list, roughly 21% or 19,411 patients are from California.
National Administration of the
Organ Procurement & Transplantation Process
The
national
system grew out of federal
legislation in 1984 to regulate what had become a free-for-all
competition
among kidney surgeons. The
legislation
sought to increase donations, prevent organ trafficking, and distribute
organs
“equitably among transplant recipients according to established medical
criteria.” In turn,
the legislation has
spurned the creation and adoption of a number of detailed processes and
policies governing the national system, including the National Organ
Transplant
Act (NOTA) of 1984 and the OPTN Final Rule, which was last amended in
1999 and
codified in 42 Code of Federal Regulations (CFR) Part 121. These policies are developed
in a
public-private partnership with input from organ transplant and
procurement
professionals, in conjunction UNOS and the OPTN Board of Directors.
OPTN. In accordance with NOTA, the purpose of the OPTN Final Rule was to help achieve the most equitable and medically effective use of human organs donated for transplantation. Toward this end, the Final Rule establishes performance goals intended to bring about:
1) Standardized criteria for placing patients on transplant waiting lists:
2) Standardized criteria for defining a patient’s medical status; and,
3) Allocation policies that make the most effective use of organs, especially by making them available whenever feasible to the most medically urgent patients who are appropriate candidates for transplantation.
The OPTN links donation and transplantation system professionals and member organizations participate in the decision-making process through representation on committees and on the Board of Directors. Both HRSA and UNOS have representation on the OPTN Board. Every transplant center, OPO, and histocompatibility laboratory in the U.S. is an OPTN member. As of August 13, 2006, 257 transplant centers, 58 OPOs, 155 histocompatability laboratories, ten voluntary health organizations, such as the American Diabetes Association, 12 general public members, including ethicists and donor family members, and 24 medical professional/scientific organizations, such as the American Medical Association, have OPTN membership.
HRSA. The Health Resources and
Services
Administration (HRSA) manages and
administers the federal OPTN and SRTR contracts.
National transplantation policies are
developed by the OPTN Board of Directors for approval by HHS and HRSA. Under regulations that
took effect March 16,
2000, HHS made it clear that organ transplantation policies will
continue, as
before, to be developed by the transplant community under the auspices
of the
OPTN Board of Directors and UNOS.
According
to the
OPTN Final Rule, the Secretary of HHS has the sole authority to
establish
conditions of participation in Medicare and Medicaid.
The Final Rule also states that “no OPTN
policies are legally binding “rules or requirements” of the OPTN…
unless they
have been approved by the Secretary.”
Furthermore,
a 1999 Institute of Medicine (IOM) report cited in the Final Rule
commentary
made five major recommendations, including that HHS “exercise the
legitimate
oversight responsibilities assigned to it by NOTA and articulated in
the final
rule, to manage the system of organ procurement and transplantation in
the
public interest.”
Finally, Section 1138 of the Social Security Act requires hospitals that perform organ transplants to be members of, and abide by the rules and requirements of, the OPTN as a condition for participation in Medicare and Medicaid for reimbursement for organ transplants. Thus, the oversight role of the Secretary of HHS becomes two-fold, as HHS oversees both HRSA and CMS (CMS oversees Medicare and Medicaid).
UNOS. UNOS surveys transplant centers and OPOs every three years. However, UNOS does not have the authority to terminate a transplant program; rather, their responsibility is to bring a program into compliance. To this end, UNOS employs a peer review process in which an OPTN member found out of compliance with federal guidelines is brought before their “peers” who serve on the UNOS Membership & Professional Standards Committee (MPSC). The MPSC reviews the qualifications, medical outcomes and professional conduct of OPTN members, and ensures that clinical transplant centers, independent organ procurement agencies, and independent tissue typing laboratories meet and remain in compliance with UNOS Criteria for Institutional Membership.
SRTR. The
SRTR contract is
administered by the Arbor Research Collaborative for Health with the
University
of Michigan and supports the ongoing evaluation of the scientific and
clinical
status of organ transplantation in the U.S.
Their responsibilities include
designing and carrying out
rigorous scientific analyses of data and disseminating information to
the
transplant community. The
U.S. organ
transplantation system employs evidence-based allocation policy
development
through collaborative efforts between the transplant community, the
SRTR, and
the OPTN.
CMS. CMS oversees data submission, outcome measure and process requirements that transplant centers must meet to participate as Medicare-approved centers. To qualify for Medicare funding, transplant centers must meet the following minimum requirements:
Type Number of Transplants Survival Rate
Heart 12 73%
Lung 10 69%
Liver 12 77%
Donor Matching System
Transplant centers, laboratories, and OPOs are all involved in the organ sharing process. A patient in need of an organ must first undergo evaluation at a transplant center. Based on the evaluation and the individual transplant center's criteria for accepting a patient for transplant, the transplant team determines if the person is a good candidate for receiving an organ. Viable candidates are then placed on the center's waiting list in the UNOS database.
Waiting times for organs vary widely and are based on multiple factors, including patient medical status, the availability of donors in the local area and the level of match between the donor and recipient. The variation is based upon many patient-specific factors, including patient health status, blood type, medical urgency, and time on the waiting list. In addition, there are external factors such as type and availability of organs, the number of transplant centers drawing from each OPO, as well as the transplant center's own criteria for accepting organ offers. Organ acceptance policies vary by center and are subject to the determination of the physician/surgeon.
CMS specifies
quality measures and data reporting requirements that OPOs must meet to
have
their services covered by Medicare and Medicaid.
The OPO becomes involved when a
patient is identified as brain dead and classified as a potential
donor. The
OPO coordinates the logistics, including obtaining consent, between the
organ
donor's family, the donated organs, the transplant center(s), and the
potential
transplant candidate. From
the moment of
consent for donation to the release of the donor's body to the morgue,
all
costs associated with the organ donation process are billed directly to
the
OPO. OPOs receive the vast majority of
their funds (75%
to 95%) through
payments from transplant centers for organs, as provided for in NOTA
and the
CMS payment regulations.
Donated
organs deemed
viable for transplant by an OPO are distributed locally first, and if
no match
is found, they are offered regionally, then nationally. All patients accepted onto
a transplant
hospital's waiting list are registered with UNOS, where a centralized
network
links OPOs and transplant centers and assists with the matching,
transporting,
and sharing of organs throughout the U.S.
When donor organs are identified, the OPO matches
the organ with
potential patients from the UNOS database. For
each organ that becomes available, a list
of potential recipients is generated and recipients are ranked
according to
objective criteria (i.e. blood type, tissue type, size of the organ,
medical
urgency of the patient, time on the waiting list, and distance between
donor
and recipient). Each
organ has its own
specific criteria. Ethnicity,
gender,
religion, and financial status are not part of the computer matching
system. The OPO's
procurement coordinator then contacts
the transplant surgeon caring for the first patient on the match list
to offer
the organ. Depending
on various factors,
such as the donor's medical history and the current health of the
potential
recipient, the transplant surgeon determines if the organ is suitable
for the
first patient on the list, given the patient's current health status
and
specific conditions of the available organ.
If the organ is turned down, the next listed
individual's transplant
center is contacted, and so on, until the organ is placed. When
an organ is turned down, the OPO is required to report to UNOS the
reason for
the refusal given by the transplant center by entering a refusal code
into the
UNOS database.
Once the organ is accepted for a potential recipient, the OPO makes organ transportation arrangements and the surgery is scheduled. For heart, lung, or liver transplantation, the recipient of the organ is identified prior to the organ recovery and called into the hospital where the transplant will occur to prepare for the surgery.
Accreditation
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accredits general acute care hospitals and other health care organizations. According to JCAHO, since the enactment of the Social Security Act in 1965, hospitals with JCAHO accreditation can be deemed to meet the federal Conditions of Participation for the Medicare and Medicaid programs. JCAHO accredited hospitals are surveyed every three years. However, the hospital accreditation survey process does not specifically look at parameters relating to transplant centers. JCAHO is in the process of creating a certification program specific to transplant centers, to begin in 2007.
State Regulation & Oversight
California
does have
a statutory framework related to a statewide organ and tissue registry,
which is operated by a nonprofit coalition of the state’s OPOs. The
law directs DHS to adopt minimum standards for preservation, transport,
storage and handling of tissues, and for testing of donors to determine
compatibility. The
law requires L&C to
audit for the existence of organ and tissue procurement procedures for
all inpatient hospital facilities.
2) The number of available organ donors;
3) The number of hospitals performing transplants and type of transplants;
4) The percentage of medically insured transplant recipients;
5) The percentage of Medi-Cal funded transplant recipients;
6) The waiting time for transplantation;
7) Factors used to determine eligibility for organ transplantation;
8) Referral rates of patients to transplant centers;
9) The number of persons accepted by transplant centers;
10) The cost of recovery, processing, and distribution of the donated organs;
11) The cost of transplantation operations;
12) The financial impact of an organ donation upon the donor and the donor's family;
13) Survival rates of patients receiving organ transplants; and,
14) Hospital compliance with protocols for identifying potential organ and tissue donors.