Healthcare Systems

Organ Transplantation

INTRODUCTION  

The Organ Transplantation Program’s performance goals of increasing the number of deceased donor organs transplanted and increasing the survival benefit of kidney transplantation supports HRSA’s mission of improving access to culturally competent, quality health care.  Increasing the number of deceased donor organs available for transplantation increases access to this life-saving procedure and contributes to improvements in health outcomes.  Additionally, improving the policies by which donor organs are allocated improves the benefit of the transplant procedure for patients and seeks to maximize the best utilization of the scarce organ resource.

The key aggregate performance measure used by the program is the number of deceased donor organs transplanted.  This measure encapsulates several intermediate measures that the Program monitors to assess its progress towards achieving its performance goals.  These measures include: the total number of deceased organ donors; the percentage of donors that meet the definition of ‘eligible donor’ (i.e., the conversion rate), the number of donors that meet cardiac-death criteria and the number of organs that are transplanted on average from each category of deceased organ donor.  The Program has established specific goals for each of these measures and continually monitors its progress towards these goals.  The Program develops new and modifies existing Program initiatives, as appropriate, based on assessments of performance results.  A key Program strategy to improve performance is the use of the Breakthrough Collaborative methodology, developed by the Institute for Healthcare Improvement, to rapidly disseminate and improve upon best organ donation practices.  Collaboratives on organ donation and organ transplantation are primarily responsible for the increases in the number of organ donors and number of organs transplanted.  Other strategies include support of efforts to test and replicate new approaches for increasing organ donation, promote public awareness about organ donation, and develop and improve state donor registries.

DISCUSSION OF RESULTS AND TARGETS

Long-Term Objective:  Expand the availability of health care, particularly to underserved, vulnerable and special needs population.

23.II.A.1. Increase the annual number of organs transplanted. 
(Baseline - FY 2003: 20,392)
           
The intent of this short-term measure is to increase the number of deceased donor organs transplanted on an annual basis.  The number of deceased donor organs transplanted in FY 2007 was 24,230.  This is 13 percent lower than the target of 27,877.  This represents a slight decrease, .94 percent, from the FY 2006 result.  (See section below on “Targets Substantially Exceeded or Not Met.”)  The FY 2009 target is 27,683 deceased donor organs transplanted.   

 23.II.A.4.  Increase the average number of organs transplanted per “non-cardiac death” donor each year.
(Baseline – FY 2003: 3.20)

Another aspect contributing to increasing the overall number of deceased donor organs transplanted is the average number of organs transplanted from each deceased donor.  The intent of this short-term goal is to increase the average number of organs procured from “non-cardiac death” donors on an annual basis.   The average number of organs transplanted from each non-cardiac death donor was 3.11 in FY 2007.  This represents a slight decrease from the FY 2006 result and 11.6 percent below the FY 2007 target.  The FY 2006 result was .63 percent decrease from the FY 2005 result.  The FY 2005 result was a .96 percent increase from the FY 2004 result. Since FY 2003, there has been an overall decrease of 2.8 percent in this measure.  (See section below on “Targets Substantially Exceeded or Not Met.”)  The FY 2009 target is 3.56 organs transplanted per non-cardiac donor.

23.II.A.5.  Increase the average number of organs transplanted per “cardiac death” donor each year.
(Baseline - FY 2003: 2.04)
           
Similar to increasing the average number of organs transplanted per non-cardiac death donor (goal II.A.4.), the intent of this short-term goal is to increase the average number of organs transplanted from “cardiac death” donors on an annual basis. The average number of organs transplanted for each cardiac-death donor was 1.92 in FY 2007.  This is 20.7 percent below the FY 2007 target and a 9.0 percent decrease from the FY 2006 result.  (See section below on “Targets Substantially Exceeded or Not Met.”).  The FY 2009 target is 2.46 organs transplanted per cardiac donor.

23.II.A.6.  Increase the average number of expected life-years gained in the first 5 years after transplantation for deceased kidney/kidney-pancreas transplants.
(Baseline - FY 2003: 0.406)
           
The intent of this short-term goal is to increase on an annual basis the average number of life-years gained in the first 5 years following transplantation for deceased kidney or kidney-pancreas transplants.  The reported value for FY 2007 was .420.  This slightly exceeds the FY 2007 goal by .48 percent and is unchanged from the FY06 actual. It also represents a 4.5 percent decrease from the FY 2005 result.  As with the other annual measures, annual variations can be expected.  The Program believes that the trend towards achieving the long-term goal is important.  While it is anticipated that improvements in kidney allocation policies will increase the benefit of kidney transplantation, it is also anticipated that there will be continued improvements in kidney dialysis technology, so predicting the relative benefit in kidney transplantation is difficult.  FY 2009 target is 0.424 life-years gained per kidney and kidney-pancreas transplant.

The OPTN is currently in the process of examining its policy for allocating deceased donor kidneys.  The current allocation system places significant emphasis on time waiting for an organ as a major determinant for allocation.  Based on the work that has been done to date, it is anticipated that a major component of the new policy will include using expected life years after transplantation as a major component of the new policy.  This approach would evaluate the patient’s benefit derived from kidney transplantation as opposed to remaining on the waiting list and continuing to be treated with kidney dialysis.  It is anticipated that the policy will also attempt to better match donor kidneys to recipients to maximize the utility of the organ. 

23.II.A.7.  Increase the total number of expected life-years gained in the first 5 years after the transplant for all deceased kidney and kidney-pancreas transplant recipients compared to what would be expected for these patients had they remained on the waiting list.
(Baseline - FY 2003: 3,871)

The intent of this short-term goal is to increase on an annual basis the total number of life-years gained in the first 5 years following transplantation for deceased kidney or kidney-pancreas transplants compared to the total life-years gained if this group had remained on the waiting list. This measure is a product of the number of kidneys and kidneys-pancreases transplanted and the average expected life-years gained from each transplanted kidney.  The total number of expected life-years gained in the first 5 years after transplant was 4,775 in FY 2007.  This is 12.8 percent less than the FY 2007 target of 5,477; it is also a 2.8 percent decrease from the FY 2006 result. The Program fell short of this target because fewer kidneys were transplanted than the number projected.  In FY 2005, the total number of expected life-years gained in the first 5 years after transplant was 4,758 which as a 7.4 percent increase from the FY 2004 result of 4,427.  Overall, the FY 2007 result still represents a 23.4 percent increase over the FY 2003 baseline.

23.II.A.2.  Increase the annual number of “non-cardiac death” donors.
(Baseline - FY 2003: 6,187)
           
The greatest contributing aspect to the increase in the overall number of deceased donor organs transplanted is the number of non-cardiac-death donors. There were 7,298 non-cardiac death donors in FY 2007, which exceeded the 7,253 goal for FY 2007 by .62 percent.  While the number of donors exceeded the FY 2007 target, the number represents a 1 percent decrease from the FY 2006 result.

In FY 2006, there were 7,375 non-cardiac death donors, 4.9 percent more than FY 2005 number of 7,032. The FY 2005 result was 4.0 percent more than the FY 2004 number of 6,759.  The FY 2004 result represents a 9.2 percent increase from the FY 2003 baseline of 6,187 non-cardiac death donors.  Overall, the FY 2007 result represents a 19.2 percent increase over FY 2003 baseline.  The FY 2009 target is 7,317 non-cardiac death donors.

23.II.A.3.  Increase the annual number of “cardiac-death” donors.
(Baseline - FY 2003: 268)
           
Another aspect contributing to the increase in the overall number of deceased donor organs transplanted is the number of cardiac-death donors.  There were 793 cardiac-death donors in FY 2007, which was 22.6 percent above the 647 number of cardiac-death donors in FY 2006.  While this is a substantial increase, the Program fell short of its 968 target by 18 percent.  (See section below on “Targets Substantially Exceeded or Not Met.”)  The FY 2009 Target is 658 cardiac-death donors. 

23.II.A.8.  Increase the annual conversion rate of eligible donors.
(Baseline - FY 2003:  52.21%)

The donor conversion rate is the percentage of ‘eligible donors’ that actually become donors. An eligible donor is a deceased individual, aged 70 or younger, whose death is determined based on neurological criteria and who does not have certain diseases and/or morbidities that would excluded the individual from becoming a donor.  The conversion rate is an intermediate measure that is useful in measuring progress towards the goal of increasing the number of donors and number of donor organs transplanted.  In FY 2007, the conversion rate was 67 percent, 7. 5 percent or 4.7 percentage points above target.  Since FY 2003, the conversion rate has increased by 28.4 percent or 14.8 percentage points from a baseline of 52.2 percent.

HRSA believes that the gains in the conversion rate are attributable to the Organ Donation Breakthrough Collaborative initiated in October 2003.  The goal of this Collaborative is to increase the organ donor conversion rate to 75 percent in the Nation’s hospitals with the greatest number of potential organ donors.  In an effort to increase the number of donor organs made available for transplantation from each deceased donor, a second Collaborative, the Organ Transplantation Breakthrough Collaborative, was launched in the fall of 2005.  The goal of this Collaborative is to increase the number of organs transplanted from each deceased donor from 3.06 to 3.75.  Together, these two Collaboratives have the potential to increase the number of deceased donor organs transplanted to nearly 35,000 annually.

23.E.  Decrease the total OPTN operating costs per deceased organ transplanted.
(Baseline - FY 2003: $924)

The intent of this goal is to reduce the total OPTN operating costs associated with organ transplantation per deceased organ transplanted on an annual basis factoring in the effects of inflation.  The reported value for FY 2007 was $1,096 -- 8.3 percent above FY 2006 result and 14.2 percent above the $960 target. Although the actual FY 2007 OPTN operating cost of $26,545,289 was less than the $26,750,000 specified in the OPTN contract, the number of deceased donor organs transplanted (24,230) was (13.1 percent) lower than FY 2007 target of 27,877 resulting in a higher cost per deceased donor organ transplanted.  (See section below on “Targets Substantially Exceeded or Not Met.”)  The FY 2009 target is $1,086 per deceased donor organ transplanted.

TARGETS SUBSTANTIALLY EXCEEDED OR NOT MET

Measure:  Increase the annual number of organs transplanted.

FY 2007 target:  27,877 deceased donor organs transplanted
FY 2007 result:   24,230 deceased donor organs transplanted

The number of deceased donor organs made available for transplantation is a function of the number of deceased donors and the number of organs that are made available for transplant from each deceased donor.  There were 8,091 deceased donors in FY 2007, which up slightly from 8,026 in FY 2006.  However, this represents an overall increase of 13 percent above the record-breaking number of 7,151 in FY 2004 and 19 percent above the 2003 base year of 20,392.

Targets for the number of deceased donor organs transplanted were established based on the best data available in 2004 on the estimated number of eligible organ donors.  These data indicated that the number of estimated number of eligible donors was 12,000 annually.  More recent data indicate that the estimated number of eligible donors is closer to 11,000 annually, and the trend in the number of eligible donors is decreasing as opposed to increasing, as had originally been projected.  While the possible causes of this decline is complex, HRSA believes that the declined in the number of eligible donors can in part be attributed to an aging population, increasing rates of diseases and morbidities, such as diabetes and hypertension, and a reduction in the number of deaths that occur in hospitals.  Additionally, the number of deceased donor organs transplanted from each deceased donor is not increasing at the rate that was originally projected in part due to some of the issues related to increases in disease and morbidities in potential deceased donors.

Out-year targets have been adjusted downward to reflect the projected smaller number of eligible donors.  The Program will continue to aggressively utilize methods such as Breakthrough Collaboratives to rapidly increase the number of donor organs made available for transplantation.

Other than Breakthrough Collaboratives, the Program is also working on other initiatives to increase the number of donors and donor organs made available for transplant.  These initiatives include support to States to implement and improve State donor registries, public and professional education campaigns and supporting research and demonstration projects to test and replicate new approaches for increasing the number of donors and donor organs made available for transplantation.  These initiatives are very important, but have a longer time horizon before the benefits of the investment are realized.

Measure:  Increase the average number of organs transplanted per “non-cardiac death” donor.

FY 2007 target:   3.52 organs transplanted per non-cardiac death donors
FY 2007 result:   3.11 organs transplanted per non-cardiac death donors

Measure:  Increase the average number of organs transplanted per “cardiac death” donor.

FY 2007 target:  2.42 organs transplanted per cardiac-death donor
FY 2007 result:  1.92 organs transplanted per cardiac-death donor

As the gap between the number of donors meeting eligible donor criteria and the maximum number of eligible donors narrows, more donors with co-morbid conditions, such as chronic hypertension, are being utilized.  These donors are referred to as ‘expanded criteria donors.’  While these donors expand the total number of donors, fewer organs, on average, can be transplanted from an expanded criteria donor. This is particularly true for the kidneys which can be damaged by chronic hypertension.

The Program is actively working to increase the number of organs transplanted from deceased donors.  One key activity that was launched in early fall of 2005 is the Organ Transplantation Breakthrough Collaborative, the purpose of which is to share the best practices of transplant hospitals and organ procurement organizations in maximizing the number of organs transplanted from each deceased donor. 

Increasing the number of organs per donor will result in thousands of additional donor organs made available for transplant.  Additionally, the Program is working with the OPTN and the organ procurement and transplant community to improve technological infrastructures to facilitate the rapid placement of organs, which will increase organ utilization, particularly for highly time-sensitive thoracic organs.  A new rapid placement system was launched by the OPTN in 2007.  The Program is also conducting a thorough review of donor comorbidities to determine whether the goals for the number of organs transplanted from each donor type need further modification.

Measure:  Increase the annual number of “cardiac-death” donors.

FY 2007 Target: 968 cardiac death donors
FY 2007 Result: 793 cardiac death donors

This measure was based on the anticipation that ethical, legal and other issues associated with cardiac-death donors would be resolved more rapidly than has been realized.  The number of cardiac-death donors has increased 295 percent since the based period in 2003.  As the number of cardiac death donors increases, it is essential that more hospitals develop policies and procedures to assure that each cases is conducted using medically and ethically appropriate procedures.  In late 2005, the national Organ Procurement and Transplantation Network (OPTN) implemented a policy requiring each transplant hospital to have policies that facilitate cardiac death donation.  As a result many hospitals spent 2006 and 2007 shepherding new policies through their internal approval processes which likely contributed to the slower rate of cardiac death donor rates than in previous years.

HRSA commissioned a study with the Institute of Medicine (IOM) to examine various approaches for increasing organ donation.  IOM issued its report in May 2006.  One of the major recommendations of the IOM was to explore the use of uncontrolled cardiac death donors as an approach for increasing the number of organs made available for transplantation. (Uncontrolled cardiac death donation refers to circumstances where donation is initially considered after death has occurred, but was not anticipated.  This may occur in the emergency department, hospital wards, ICU/special care unit or pre-hospital locations.)  The IOM estimates that at least 22,000 uncontrolled cardiac deaths may result in organ donation annually. 

As the IOM recognized, there are numerous ethical, technical and administrative issues that must be resolved before the full potential of cardiac death donors may be realized.  A major focus of the Organ Transplantation Breakthrough Collaborative that was launched in the fall of 2005 is to increase the number of cardiac death donors.  The Program believes that the number of cardiac-death donors will continue to increase, however, at a much slower pace.  Based on discussions with experts in the community, the Program has established a performance goal of achieving 10% cardiac-death donors of the total number of deceased donors by 2013.  As more hospitals develop formalized cardiac death donation policies and as HRSA increases its focus on spreading effective donation practices to all hospitals, it is expected that the number of cases will reach the targets established by the Program.  In FY 2007, HRSA, through the Clinical and Interventions Grant Program awarded two grants to two separate entities to further to explore the potential of uncontrolled cardiac deaths as a way to increase the pool of organs available for transplantation.

Measure:  Decrease the total OPTN operating costs per deceased organ transplanted.

FY 2007 Target:  $960 per deceased transplant facilitated
FY 2007 Result:  $1,096 per deceased transplant facilitated

This measure is based on goal 23.II.A.2., the number of deceased organs transplanted, and the expenses associated with operating the Organ Procurement and Transplantation Network (OPTN).  Even though actual operating costs were below those projected, the target number of deceased organs transplanted was not met (see the annual number of organs transplanted above for more details), therefore the OPTN operating cost per deceased donor organ transplanted was greater than anticipated.

HRSA has expanded the role of the OPTN with respect to living organ donation and transplantation.  The OPTN is now responsible for establishing program criteria for transplant programs that perform transplants using living donor organs and for monitoring compliance with these criteria.  This role will continue to expand as a result of the enactment of the Charlie Norwood Living Organ Donation Act (H.R. 710) that permits the paired-exchange of living donor organs.  This complex system will allow multi-level pairing of donor organs from individuals who desire to donate a kidney to an intended recipient, but have an incompatible tissue type with the intended recipient. The OPTN will be the entity responsible for establishing a national system to facilitate these living donor organ exchanges. These activities are impacting the overall operating cost of the OPTN.

Under the current OPTN contract that was negotiated in late FY 2005, after the targets for this performance measure were established, HRSA authorized the OPTN to invest in improving its information technology (IT) infrastructure in FY 2006 and FY 2007.  These IT improvements are supportive of the long-term strategic goal to increase the number of deceased organs transplanted and will increase the efficiency by which organs are allocated.  It is expected that through technological and other OPTN system efficiencies, the Program will achieve increases in the number of organs transplanted. This will curb the rate of increase and possibly decrease the cost per organ transplanted in subsequent fiscal years.

Additionally, the OPTN expanded its oversight activities in 2006 and 2007 in response to several high-profile incidents that occurred in California that involved transplant programs that did not abide by the OPTN final rule, OPTN bylaws and policies.  This expansion of oversight activities was not envisioned in FY 2004 when the performance goals were established.  These activities have and will continue to increase the OPTN operating costs.

The IT improvements are supportive of the long-term strategic goal to increase the number of deceased organs transplanted and will increase the efficiency by which organs are allocated.  It is expected that through technological and other OPTN system efficiencies, the Program will achieve increases in the number of organs transplanted.

The OPTN has been making greater usage of technology such as teleconferencing, Live Meeting to reduce travel costs.  In addition, the OPTN is looking at ways to reduce the number of committee members without interfering with the committee’s strategic goal.  Fewer committee members will result in reducing travel costs.

The increasing cost of operation of the OPTN does not impact the Federal funds provided for the operations of the OPTN.  HRSA, by statute, can provide no more than $2 million each fiscal year toward the operations of the OPTN.  Additional funds to operate the OPTN come from registration fees charged to register patients on the organ waitlist.