HEALTHCARE SYSTEMS

Programs included in this section are:

ORGAN TRANSPLANTATION

Notes:

 ^a This goal is primarily dependent on converting the number of eligible donors to actual donors.  In establishing this performance goal in 2004 as a result of the PART analysis, the Program used the best newly collected information from the OPTN that indicated there were approximately 12,000 eligible donors. As a result of refinements in data collection definitions and more uniform reporting of data, the best estimate of the current number of eligible donors is 11,000. It is anticipated that this number will hold stable and may actually decline over the next several years. If 11,000 eligible donors in conjunction with the other changes described in the notes below were used in the projection of this performance measure, the target for 2013 will be 33,473 instead of the current 42,800. Targets for FYs 08 and 09 are based on the revised assumptions that are described in these notes.

 ^b An analysis conducted in association with the Organ Transplantation Breakthrough Collaborative indicates that a long-term goal of 3.75 vs. the initial goal of 4.0 is more realistic.  Targets for FYs 08 and 09 are based on this assumption.

^c An analysis conducted in association with the Organ Transplantation Breakthrough Collaborative indicates that a long-term goal of 2.75 vs. the initial goal of 3.0 is more realistic.  Targets for FYs 08 and 09 are based on this assumption.

^d  This goal is based on the projections for the total number of kidney and kidney/pancreas transplants performed using deceased donor organs.  This estimate is related directly to performance measure 23.II, A.5 (see note a).  The number of deceased donor kidney and kidney/pancreas transplants is assumed to be 50% of the annual total number of deceased donor organs transplanted.  Targets for FYs 08 and 09 are based on this assumption.

^e This measure is implicit in the target for the number of deceased donor organs transplanted.  However, since this measure is widely used by OPOs and the Department in assessing donor hospital performance and was a key measure used in the Organ Donation Breakthrough Collaborative, it is being included as a performance measure for purposes of transparency.

^f  The initial measure was developed based on the assumption that there were 12,000 eligible donors. Per note (a) above, the estimate is closer to 11,000. This measure assumes an increasing percentage of eligible donors to actual donors over time until a 75% conversion rate is achieved in 2013.  The revised annual increase is 234 instead of 333.  Targets for FYs 08 and 09 are based on this assumption.

^g This measure was based on the assumption that the number of cardiac-death donors would be increased by 175 each year.  Analysis conducted in association with the Organ Transplantation Breakthrough Collaborative indicates that a long-term goal of 10% cardiac death donors as a percentage of total deceased donors is a more realistic target.  The revised annual increase is 0.57%.  Targets for FYs 08 and 09 are based on this assumption.

^h The OPTN cost per deceased donor organ transplanted is influenced by the number of deceased donor organs transplanted and the total cost of OPTN operations including both Federal and non-Federal support.  The FY 08 and 09 targets were adjusted upward to reflect the revised target for the number of deceased donor organs transplanted (see note a).  Additionally, the costs of OPTN operations have increased to provide greater information technology capability and expanded OPTN member compliance review and oversight.

ⁱ  The current OPTN contract ends in FY 11.

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 in accordance with projections until 42,800 organs are transplanted in 2013.

(Baseline - FY 03: 20,392)

The intent of this short-term measure is to increase the number of deceased donor organs transplanted on an annual basis so that by FY 13 the long-term goal will be met.  The number of deceased donor organs transplanted in FY 06 was 24,461.  This represents a 5.2 percent increase above the FY 05 number, but falls 4.6 percent short of the ambitious 25,651 target.  (See section below on “Targets Substantially Exceeded or Not Met.”) The FY 09 target is 27,683 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.  The Program continues to make strong gains in the number of deceased donors.  There were 8,022 deceased donors in FY 06, an increase of 5.6 percent above the previous year and an overall increase of 12.2 percent above the record-breaking number of 7,151 in FY 04.  In contrast, the annual rate of growth in the number of deceased donors was approximately 2.5 percent for the previous 10 year period.  HRSA believes that the rapid gain in the number of deceased donors is largely 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 FY 06 the conversion rate was 64 percent, which is 6 percentage points higher than the 59 percent in FY 05, and 12 percentage points higher than the 52 percent rate in FY 03, when the Organ Donation Breakthrough Collaborative began.  In an effort to increase the number of donors made available for transplant 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 35,000 if the goals are achieved.

 23.II.A.4.  Increase the average number of organs transplanted per “non-cardiac death” donor each year by 0.08 until the average of 4.00 is achieved in 2013.

(Baseline – FY 03: 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 so that by FY 13 the long-term goal will be met.  The average number of organs transplanted from each non-cardiac death donor was 3.13 in FY 06. This represents a .63 percent decrease from FY 05 results and 9.0 percent below the FY 06 target.  The FY 05 result was less than 1 percent increase from the FY 04 result.  Since FY 03, there has been an overall decrease of 2.2 percent in this measure. This is a highly variable metric and annual variations can be expected.  (See section below on “Targets Substantially Exceeded or Not Met.”) The FY 09 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 by 0.096 until the average of 3.00 is achieved in 2013.

(Baseline - FY 03: 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 so that by FY 13 the long-term goal will be met.  The average number of organs transplanted for each cardiac-death donor was 2.11 in FY 06.  This is 9.4 percent below the FY 06 target.  Although the result was below target, it represents a 7.1 percent increase over the FY 05 result.  (See section below on “Targets Substantially Exceeded or Not Met.”) The FY 09 target is 2.46 organs transplanted per cardiac donor.

23.II.A.6.  Increase the average number of life-years gained in the first 5 years after transplantation for deceased kidney/kidney-pancreas transplants by 0.003 life-years until the goal of 0.436 life-years gained per transplant is achieved in 2013.

(Baseline - FY 03: 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 by 0.003 life-years until the goal of 0.436 life-years gained per transplant is achieved by FY 13.  The reported value for FY 06 was .420.  This exceeds the FY 06 goal by 1.2 percent.  However, it is 4.5 percent below FY 05 results.  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 09 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 a great deal of emphasis on waiting time as a major determinant for allocation. The potential of a net lifetime survival model (NLS) as a method for allocating kidneys is currently being evaluated by the OPTN.  This approach would evaluate the benefit derived from kidney transplantation as opposed to remaining on the waiting list and continuing to be dialyzed.  It is anticipated that a new kidney allocation policy will be put in place in FY 08.

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 03: 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 to 8,543 total life-years gained compared to the total life-years gained if this group had remained on the waiting list.  The total number of expected life-years gained in the first 5 years after transplant was 4,913 in FY 06.  This is 2.7 percent less than the FY 06 target; however, it is a 3.3 percent increase from FY 05 results. In FY 05, 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 04 result of 4,427.  The FY 05 result represents a 14.4 percent increase over 2003 baseline.  Overall, the FY 06 result represents a 26.9 percent increase over FY 03 baseline. Based on clinical improvements and improvements in kidney allocation policies as described in 23.II.A.6.,  it is anticipated that there will be continued increases in the total number of expected life-years gained.  The FY 09 target is 5,873 expected life-years gained for the first 5 years after kidney and kidney-pancreas transplant.

23.II.A.2.  Increase the annual number of “non-cardiac death” donors by 333 until the number of 9,251 “non-cardiac death” donors is achieved in 2013.

(Baseline - FY 03: 6,187)

The intent of this short-term goal is to increase the number of “non-cardiac death” donors by 333 each year until the long-term goal of 9,251 non-cardiac donors is achieved by FY 13.  The baseline value for this goal is 6,187 in FY 03.  There were 7,375 in FY 06, which exceeded the 6,920 goal for FY 06 by 4.9 percent. This result is primarily attributable to the success of the Organ Donation and Transplantation Breakthrough Collaboratives.  (See section below on “Targets Substantially Exceeded or Not Met.”)

In FY 05, there were 7,032 non-cardiac death donors, 4.0 percent more than the FY 04 number of 6,759.  The FY 04 result represents a 9.2 percent increase from the FY 03 baseline of 6,187 non-cardiac death donors.  Overall, the FY 06 result represents a 19.2 percent increase over FY 03 baseline.  The FY 09 target is 7,317 non-cardiac death donors.

23.II.A.3.  Increase the annual number of “cardiac-death” donors by 175 each year until the number 2,018 “cardiac-death” donors is achieved in 2013.

(Baseline - FY 03: 268)

Another aspect contributing to the increase in the overall number of deceased donor organs transplanted is the number of cardiac-death donors.  The intent of this short-term goal is to increase the number of cardiac-death donors on an annual basis so that by FY 2013 the long-term goal will be met.  There were 647 cardiac-death donors in FY 2006, which was 15.3 percent above the 561 cardiac-death donors in FY 2005.  While this is a substantial increase, the Program fell short of its 793 target by approximately 18 percent.  (See section below on “Targets Substantially Exceeded or Not Met.”)  The FY 09 Target is 658 cardiac-death donors. 

23.E. Decrease the total OPTN operating costs per deceased organ transplanted.

(Baseline - FY 03: $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 06 was $1,012 -- 2.6 percent above FY 05 results and 3.6 percent above the $975 target. Although the actual FY 06 OPTN operating cost of $24,749,199 was less than the $25,000,000 specified in the OPTN contract, the number of deceased donor organs transplanted (24,461) was (4.6 percent) lower than FY 06 target of 25,651, resulting in a higher cost per deceased donor organ transplanted.  (See section below on “Targets Substantially Exceeded or Not Met.”)  The FY 09 target is $1,117 per deceased donor organ transplanted.

TARGETS SUBSTANTIALLY EXCEEDED OR NOT MET

Measure: Increase the annual number of organs transplanted in accordance with projections until 42,800 organs are transplanted in 2013.

FY 06 target:  25,651 deceased donor organs transplanted

FY 06 result:   24,461 deceased donor organs transplanted

While the number of organs transplanted has continued to increase, the number of organs transplanted in FY 06 fell below the target due to the overestimation of the number of potential deceased organ donors. The target was set based on the best data available at the time on the number of eligible organ donors. That data indicated that the number of eligible donors was 12,000 annually.  More recent data indicate that there are only approximately 11,000 eligible donors annually and the trend in the number of eligible donors is decreasing as opposed to increasing as had originally been projected.  Additionally, the number of deceased donor organs transplanted from each deceased donor is not increasing at the rate that was originally projected. 

Out-year targets have been adjusted downward to reflect the projected smaller number of eligible donors.  The Program will continue to make use of Breakthrough Collaboratives as a method for rapidly increasing the number of donor organs made available for transplantation.

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 each year by 0.08 until the average of 4.00 is achieved in 2013.

FY 06 target:  3.44 organs transplanted per non-cardiac death donors

FY 06 result:   3.13 organs transplanted per non-cardiac death donors

Measure: Increase the average number of organs transplanted per “cardiac death” donor each year by 0.096 until the average of 3.00 is achieved in 2013.

FY 06 target:  2.33 organs transplanted per cardiac-death donor

FY 06 result:   2.11 organs transplanted per cardiac-death donor

As the gap between the number of donors meeting eligible donor criteria and the total number of eligible donors narrows, more donors with comorbid conditions are utilized.  These comorbid conditions, such as chronic hypertension (i.e., high blood pressure), result in a reduction in the number of organs from each donor that are acceptable for transplantation.  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 “non-cardiac death” donors by 333 until the number of 9,251 “non-cardiac death” donors is achieved in 2013.

FY 06 Target:  6,920 non-cardiac death donors

FY 06 Result:  7,375 non-cardiac death donors

This result is primarily attributable to the success of the Organ Donation and Transplantation Breakthrough Collaboratives. These Collaboratives have proven to be a highly-effective method of rapidly disseminating and improving upon best organ donation practices

The Program has funded initiatives that 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.

The Program will continue to make use of Breakthrough Collaboratives as a method for rapidly increasing the number of donor organs made available for transplantation and fund other initiatives for the purpose of increasing the number of donors and donor organs made available for transplantation.

Measure: Increase the annual number of “cardiac-death” donors by 175 each year until the number 2,018 “cardiac death” donors is achieved in 2013.           

FY 06 Target: 793 cardiac death donors

FY 06 Result: 647 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 significantly over the past three (3) years. As the frequency of cardiac death donation 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 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 22,000 uncontrolled cardiac deaths may result in organ donation.  HRSA is actively exploring approaches for increasing the number of these donors.

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 is 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 goals.

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

FY 06 Target:  $975 per deceased transplant facilitated

FY 06 Result:  $1,012 per deceased transplant facilitated

This measure is based on goal 23.II.A.2., the number of deceased organs transplanted, and the overall OPTN operating budget.  Even though the budget was slightly under, the target number of deceased organs transplanted was not met (see the annual number of organs transplanted above for more details), therefore the per deceased donor organ transplanted cost was greater than anticipated.

The Department 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 05, after the targets for this performance measure were established, HRSA authorized the OPTN to invest in improving its information technology (IT) infrastructure in FY 06 and FY 07.  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 04 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.

C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM