HEALTHCARE
SYSTEMS
Programs
included in this section are:
ORGAN
TRANSPLANTATION
# |
Key
Outcomes |
FY
2004 Actual |
FY
2005 Actual |
FY
2006 |
FY
2007 |
FY
2008
Target |
FY
2009
Target |
Out-Year
Target |
Target |
Actual |
Target |
Actual |
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 42,800a
organs are transplanted in 2013.
(Baseline—2003:
20,392) |
21,949 |
23,249 |
25,651 |
24,461 |
27,877 |
Apr
08 |
26,314 |
27,683 |
2013:
42,800 |
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 b is achieved
in 2013.
(Baseline—2003:
3.20) |
3.12 |
3.15 |
3.44 |
3.13 |
3.52 |
Apr-08 |
3.52 |
3.56 |
2013:
4.00 |
23.
II.
A.
5. |
Increase
the average number of organs transplanted per
“cardiac death” donor each year by 0.096 until
the average of 3.00c is achieved
in 2013.
(Baseline—2003:
2.04) |
2.02 |
1.97 |
2.33 |
2.11 |
2.42 |
Apr-08 |
2.39 |
2.46 |
2013:
3.00 |
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—2003:
0.406) |
0.433 |
0.440 |
0.415 |
0.420 |
0.418 |
Apr-08 |
0.421 |
0.424 |
2013:
0.436 |
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. d
(Baseline—2003:
3,871) |
4,427 |
4,758 |
5,048 |
4,913 |
5,477 |
Apr-08 |
5,543 |
5,873 |
2013:
8,543 |
# |
Key
Outputs |
FY
2004 Actual |
FY
2005
Actual |
FY
2006 |
FY
2007 |
FY
2008 Target/ Est. |
FY
2009 Target/ Est. |
Out-Year
Target/ Est. |
Target/
Est. |
Actual |
Target/
Est. |
Actual |
Long-Term
Objective: Expand the availability of health
care, particularly to underserved, vulnerable
and special needs population |
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. f
(Baseline
2003: 6,187) |
6,759 |
7,032 |
6,920 |
7,375 |
7,253 |
Apr-08 |
7,083 |
7,317 |
2013:
9,251 |
23.
II.
A.
3. |
Increase
the annual number of “cardiac death” donors
by 175 until the number of 2,018 “cardiac death”
donors is achieved in 2013.g
(Baseline
2003: 268) |
391 |
561 |
793 |
647 |
968 |
Apr-08 |
593 |
658 |
2013:
2,018 |
Efficiency
Measure |
23.E. |
Decrease
the total OPTN operating costs per deceased
organ transplanted.
(Baseline
2003: $924) h |
$933 |
$986 |
$975 |
$1,012 |
$960 |
May-08 |
$1,098 |
$1,117 |
2011:
$1,185i |
|
Appropriated
Amount
($
Millions) |
$24.6 |
$24.4 |
|
$23.0 |
|
$23.0 |
$23.0 |
$23.0 |
|
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
# |
Key
Outcomes |
FY
2004 Actual |
FY
2005 Actual |
FY
2006 |
FY
2007 |
FY
2008
Target |
FY
2009
Target |
Out
Year Target |
Target |
Actual |
Target |
Actual |
Long-Term
Objective: Expand the availability of health
care, particularly to underserved, vulnerable,
and special needs populations |
24.1 |
Increase
by 95% the number of blood stem cell transplants
facilitated annually by the Registry.
(Baseline
- 2003: 2,310) |
|
|
|
|
|
|
|
|
2010:
4,505 |
24.2 |
Increase
by 100% the number of blood stem cell transplants
facilitated annually by the Registry for minority
patients.
(Baseline
- 2003: 318) |
|
|
|
|
|
|
|
|
2010:
636 |
24.3 |
Increase
the rate of patient survival at one year, post
transplant.
(Baseline:
2003, 62%) |
|
|
|
|
|
|
|
|
2010:
69% |
# |
Key
Outputs |
FY
2004 Actual |
FY
2005 Actual |
FY
2006 |
FY
2007 |
FY
2008
Target/
Est. |
FY
2009
Target/
Est. |
Out
Year Target/ Est. |
Target/
Est. |
Actual |
Target/
Est. |
Actual |
Long-Term
Objective: Expand the availability of health
care, particularly to underserved, vulnerable,
and special needs populations |
24.
II.
A.1 |
Increase
the number of cord blood units listed on the
Registry. |
35,926 |
45,807 |
36,500 |
51,693 |
38,500 |
69,081 |
NAa |
NAa |
|
24.
II.
A.2. |
Increase
the number of adult volunteer potential donors
of minority race and ethnicity. |
1.47
M |
1.59
M |
1.71
M |
1.70
M |
1.83
M |
1.85M |
1.94
M |
2.06
M |
|
Efficiency
Measure |
24.E. |
Decrease
the unit cost of HLA-typing of potential donors
by 2% each year. |
$63.65 |
$63.65 |
$61.17 |
$52.00 |
$59.95 |
$52.00 |
$52.00 |
$52.00 |
$52.00 |
|
Appropriated
Amount
($
Million) |
$22.6 |
$25.4 |
|
$25.1 |
|
$25.2 |
$23.5 |
$22.7 |
|
Notes
a
The FY 08 and 09 targets for 24.II.A.1.
have been changed to NA (not applicable) as
a result of the new program structure per P.L.
109-129, under which HRSA funding for cord blood
collection occurs through a related program,
the National Cord Blood Inventory. Appropriate
measures and targets for the National Cord Blood
Inventory will be developed by Summer 2008.
INTRODUCTION
The
Stem Cell Therapeutic and Research Act of 2005 (P.L.
109-129) authorized the C.W. Bill Young Cell Transplantation
Program (Program) as successor to the National Bone
Marrow Donor Registry. The performance measures and
targets discussed below were established for the Registry
(new measures and targets have not yet been established
for the Program). The performance measures allow
HRSA program staff to monitor progress towards the
overarching goal of increasing access to blood stem
cell transplant for patients in need of these life
saving therapies with a particular emphasis on eliminating
racial and ethnic barriers to accessing suitable blood
stem cell sources. Strategies used to ensure that
performance targets are met include: incorporation
of quantitative performance standards into each of
the four contracts for the Program; alignment of the
contractor’s strategic and operational plans with
the standards; quarterly reporting and reviews by
HRSA and the contractors of performance against the
standards; development of a process to improve donor
searches; aggressive contractor negotiations of cost
reductions in subcontracts for tissue typing; and
development and funding of new initiatives to increase
awareness and outreach in support of recruiting minority
donors.
DISCUSSION
OF RESULTS AND TARGETS
Long-Term
Objective: Expand the availability of health care,
particularly to underserved, vulnerable, and special
needs populations
24.1.
Increase by 95% the number of blood stem cell transplants
facilitated annually by the Registry.
(Baseline
– 2003: 2,310)
The
purpose of the program is to increase the number of
unrelated blood stem cell transplants facilitated
for patients in need. This long-term goal directly
reflects the program’s purpose.
24.2.
Increase by 100% the number of blood stem cell transplants
facilitated annually by the Registry for minority
patients.
(Baseline
– 2003: 318)
Reaching
this goal will further the statutory aim of ensuring
that patients from racially and ethnically diverse
backgrounds will have a chance of receiving an unrelated
blood stem cell transplant that is comparable to that
of non-Hispanic Caucasian patients.
24.3.
Increase the rate of patient survival at one
year, post transplant.
(Baseline:
2003, 62%)
The
intent of this health outcome measure is to increase
the health benefit to patients receiving an unrelated
blood stem cell transplant. The program recognizes
that it does not have a direct impact on patient care
delivery. Nonetheless, the program can influence
survival rates in several ways, including improving
the degree of tissue-type match between patient and
donor by adding adult volunteer potential donors and
cord blood units to the Registry, ensuring that the
Registry is working with highly competent transplant
centers and other organizations, decreasing the time
required to identify the best available donor for
each patient, and engaging in research to improve
transplant outcomes (e.g., by better prevention and
treatment of infections and other transplant complications).
The baseline for this measure in 2003 is 62%. The
target for 2010 is 69%.
24.II.A.1.
Increase the number of cord blood units listed on
the Registry.
In
FY 05, the Registry listed 45,807 cord blood units.
In FY 06, the Registry listed 51,693 units, a 12.8%
increase over FY 05. In FY 07, the Registry listed
69,081 units, which is close to 1.8 times the target
of 38,500 units. The targets established for FY 07-09
have now been met with the FY 07 target having been
substantially exceeded. (See section below on “Targets
Substantially Exceeded or Not Met.”) The success
in achieving these targets can largely be attributed
to increasing the number of cord blood banks participating
in the program and making cord blood units available
to patients through the program.
24.II.A.2.
Increase the number of adult volunteer potential donors
of minority race and ethnicity.
Reaching
this goal will increase the number of patients from
racially and ethnically diverse backgrounds able to
find a suitably matched unrelated adult donor for
their blood stem cell transplant. This will lead
to more minority patients receiving unrelated donor
transplants.
In
FY 05, a total of 5,907,923 adult volunteers were
listed on the Registry, of whom 1,591,628 (or 26.9%)
self-identified as belonging to a racial/ethnic minority
population group. In FY 06, a total of 6,317,827
adult volunteers were listed on the Registry, of whom
1,698,616 (or 26.9%) self-identified as belonging
to a racial/ethnic minority population group. In
FY 07, a total of 6,856,150 adult volunteer donors
were listed on the Registry of whom 1,856,434 (or
27.1%) self-identified as belonging to a racial/ethnic
minority population group (exceeding the goal of 1.8
million). Initiatives to increase community awareness
and outreach in minority populations were implemented
in FY 06 and additional funds were committed to this
effort for FY 07 to make improvements in meeting the
annual targets established for the Registry. The
program expects to continue achieving future targets.
The target established for FY 09 is 2,060,000 adult
volunteers from racially/ethnically under-represented
minority population groups.
24.E.
Decrease the unit cost of HLA-typing of potential
donors by 2% each year.
The
cost of Human Leukocyte Antigen (HLA) typing strongly
influences the number of potential volunteer donors
who can be recruited to join the Registry. Reductions
in the cost of typing makes increases in donor recruitment
possible even without increased funding. In FY 04,
the National Marrow Donor Program successfully negotiated
a 2.7% reduction in cost with its contracted laboratories
for Human Leukocyte Antigen (HLA) tissue typing.
The cost of tissue typing decreased from $65.00 in
FY 03 to $63.65 in FY 04. The Registry contractor
did not negotiate new laboratory contracts during
FY 05. In FY 06, the Registry negotiated an 18% cost
reduction, which was expected to remain in effect
over the next three years. This reduction in tissue
typing cost to $52.00 far exceeds the annual target
for FY 07 of $59.95. The FY 08 and FY 09 targets
remain $52.00.
TARGETS
SUBSTANTIALLY EXCEEDED OR NOT MET
Target
Substantially Exceeded
Measure:
Increase the number of cord blood units listed on
the Registry.
FY
07 Target: 38,500
FY
07 Result: 69,081
When
developed, the Program’s target was ambitious given
the fact that the listing of umbilical cord blood
units on the Registry was a relatively new aspect
of the Program. The target was
exceeded
in large part through increasing the number of blood
banks participating in the program and making cord
blood units available to patients through the program.
The
targets established for FY 07- 09 have been exceeded.
Funding for the collection and storage of cord blood
units has transitioned from the C.W. Bill Young Cell
Transplantation Program to a related program, the
National Cord Blood Inventory. New targets are not
being proposed under this program. Separate goals
are being developed for the National Cord Blood Inventory
and HRSA will propose deleting this goal from the
Program’s performance measures and establishing a
cord blood collection goal for new units for the National
Cord Blood Inventory.
The
impact of this result is that more people in need
of blood stem cell transplantation, particularly minority
patients, are able to find an adequate cord blood
unit for transplantation through the Program.
POISON CONTROL PROGRAM
# |
Key
Outcomes |
FY
2004 Actual |
FY
2005 Actual |
FY
2006 |
FY
2007 |
FY
2008
Target |
FY
2009
Target |
Out-Year
Target |
Target |
Actual |
Target |
Actual |
Long-Term
Objective: Promote the implementation of evidence-based
methodologies and best practices |
25.1 |
Decrease
the number of visits to the emergency room
(Baseline-2002:
2.05 live ER discharges per 1,000) |
|
|
|
|
|
|
|
25%
below baseline |
|
# |
Key
Outputs |
FY
2004 Actual |
FY
2005
Actual |
FY
2006 |
FY
2007 |
FY
2008 Target/ Est. |
FY
2009 Target/ Est. |
Out-Year
Target/ Est. |
Target/
Est. |
Actual |
Target/
Est. |
Actual |
Long-Term
Objective: Promote the implementation of evidence-based
methodologies and best practices |
25.
III.D.1 |
Develop
and ratify uniform and evidence-based guidelines
for the treatment of poisoning. |
3
(cumulative) |
6 |
9 |
16 |
18 |
17 |
17a |
NA |
|
25.
III.D.2 |
Increase
the number of PCCs with 24-hour bilingual staff. |
1 |
4 |
5 |
4 |
4 |
4b |
4b |
4b |
|
25.
III.D.3 |
Increase
percent of inbound volume on the toll-free number |
46.8% |
52.0% |
49.1% |
57.5% |
63.3% |
66% |
69.3% |
69.3% |
|
Efficiency
Measure |
25.
E |
Decrease
application and reporting time burden (120 and
85 hrs est. baseline 2005) |
NA |
NA |
114
& 81 hrs |
30.5
& 20 hrs. |
29
& 19 hrs. |
Mar-08c
|
29
& 19 |
27.5
& 18 |
|
|
Appropriated
Amount
($
Million) |
$23.7 |
$23.5 |
|
$23.1 |
|
$23.0 |
$26.5 |
$10.0 |
|
Notes:
a
The FY 08 target for 24.III.D.1 was reduced
from 18 to 17 as the final extension on the cooperative
agreement expires December, 2007, precluding the ability
to conduct extensive work required to develop a guideline.
Program is conducting an evaluation of use of developed
guidelines, therefore FY 09 is NA.
b
In September 2006, HRSA began providing translation
services to all PCCs through a service called Language
Line. Language Line provides translations services
in 161 languages. Therefore, targets for bilingual
staff have not increased.
c
FY 08 is a new grant cycle (and not continuation)
with a requirement to report application and reporting
time annually. However, grantees misunderstood the
requirement and did not include this information when
they submitted their new application. The program
is in the process of gathering this information and
will have it by March 2008.
INTRODUCTION
The
performance goals align with the Poison Control Program
goal to ensure universal access to quality poison
control services. The performance measures to increase
calls to the national toll-free number, develop uniform
guidelines and provide access to bilingual services
are utilized for program strategic planning to ensure
that the program is increasing access to comprehensive
quality services for the entire population, particularly
children who are the most vulnerable to poisonings.
Strategies used by the Program include a national
media campaign to promote the Poison Control toll
free number, and developing partnerships with private
and public organizations to promote poison prevention.
The Program also provides technical assistance to
Poison Control Centers on such issues as financial
planning, marketing, infrastructure development, and
data analysis.
DISCUSSION
OF RESULTS AND TARGETS
Long-Term
Objective: Promote the implementation of evidence-based
methodologies and best practices
25.1.
By 2009, decrease the number of visits to the emergency
room by 25 percent.
(Baseline
- 2002: 2.05 live ER discharges per 1,000)
Decreasing
unneeded emergency room visits for poisoning or suspected
poisoning will reduce unnecessary utilization of extremely
costly resources, and allow those resources to be
better utilized for persons in need of them.
25.III.D.1.
Develop and ratify uniform and evidence-based guidelines
for the treatment of poisoning.
Having
evidence-based guidelines available for use at the
poison control centers will improve uniformity and
standard care for acute poisoning-related incidents,
thereby improving the quality of care. The baseline
for FY 04 is the cumulative total of guidelines developed
and ratified, 3; one guideline covering 35 non-toxic
substances and two guidelines for the treatment of
toxic poisonings. The goal to develop three additional
guidelines in FY 05 was met in June 2005.
Ten
guidelines were completed in FY 06 and one additional
guideline in FY 07, making the total number of guidelines
developed 17. The target for FY 07 was 18 and was
not met, therefore the FY 08 target was reduced from
18 to 17 because the final extension on the cooperative
agreement expires December, 2007, precluding the ability
to conduct the extensive work required to develop
a guideline. The program is conducting an evaluation
of the use of the developed guidelines, therefore
a FY 09 target is not applicable.
25.III.D.2.
Increase the number of PCCs with 24-hour bilingual
staff.
According
to the American Association of Poison Control Centers
(AAPCC), in 2004 only 1 of 62 Poison Control Centers
in the U.S. had 24-hour bilingual staff. In order
for the Poison Control Program (PCP) to ensure universal
access and serve a larger population, the original
goal was to increase the number of PCCs with 24-hour
bilingual staff coverage by at least 2 centers per
year. In FY 05, the PCP queried all the PCCs and
found that 4 provided 24-hour bilingual services.
In FY 06, there remain four PCCs with 24-hour bilingual
staff, one below the FY 06 performance goal of five.
However, in September of 2006, HRSA began providing
translation services to all PCCs through a service
called Language Line. Language Line provides translation
services in 161 languages thereby providing a cost
effective means for all PCCs to offer 24-hour bilingual
services. Given the challenges with recruiting qualified
bi-lingual health care providers and the successful
implementation of Language Line, the target for this
measure has been set and will remain at four. The
program will explore an alternative to this measure
in the future.
25.III.D.3.
Increase percent of inbound volume on the toll-free
number.
Public
Law 106-174, the Poison Control Enhancement and Awareness
Act, mandated the development of a single, national
toll-free number to ensure universal access to poison
control services. In 2002, the Poison Control Program,
in conjunction with the Centers for Disease Control
and Prevention (CDC), initiated a national media campaign
to promote the use of 1-800-222-1222. Increasing
the use of the national number provides universal
access and provides individuals the resource to determine
the severity of the exposure and respond accordingly,
which has proven to reduce the number of emergency
room visits. According to the AAPCC in 2002, the
baseline year, 24.6% of callers utilized the new toll-free
number. By 2004, the percentage increased to 46.8%
and was up to 52% in 2005. In 2006, 57.5% of calls
to poison control centers were on the toll-free number
and in 2007 the percentage of calls was 66%, exceeding
the 2007 target of 63.3%. The FY 08 and FY 09 target
is to increase the percentage of calls to 69.3%; it
is expected that the percentage of usage will begin
to level out.
25.E.
Decrease the application and reporting time burden
of grantees by 5% per year for 4 years, thereby collecting
more accurate and timely data.
A
new on-line application and reporting system was implemented
in FY 05 and was fully implemented in FY 06. This
system was designed to simplify data collection by
prepopulating forms with electronic information from
previous years, including budget and service data,
eliminating the need for grantees to reenter it.
The system also eliminates the need for grantees to
reenter the same information in different parts of
the application. Reporting is also designed to be
easier on the on-line system and provides performance
data that are far more reliable and valid, with a
shorter lag time. The annual target is a 5% reduction
from the baseline. In March 2005, a limited number
of PCCs were queried to determine a baseline number
of hours to complete a grant application and to determine
the number of hours to complete a financial report
on grant activities. From this limited query an average
number of hours was calculated. The results were
120 hours for an application and 85 hours for a financial
reporting document. For 2006, all grantees were required
to provide this information as part of their grant
submission. Per the grant submissions, the average
number of hours to complete the on-line application
was 30.5 and the average number of hours to complete
a financial reporting document was 20, both far exceeding
the goal to reduce the application and reporting time
burden of grantees. FY 08 is a new grant cycle (and
not continuation) with a requirement to report application
and reporting time annually. However, grantees misunderstood
the requirement and did not include this information
when they submitted their new application. The program
is in the process of gathering this information and
will be able to report on the 2007 data by March 2008.
The FY 08 target is 29 hours for completing the grant
application and 19 hours for completing the financial
reporting; the FY 09 targets are 27.5 and 18, respectively.
|