Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
Medicare Conditions of Participation for 
Organ Donation: 
An Early Assessment of the New Donation Rule 
JUNE GIBBS BROWN 
Inspector General 
AUGUST 2000 
OEI-01-99-00020  OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 
protect the integrity of the Department of Health and Human Services programs as well as the 
health and welfare of beneficiaries served by them.  This statutory mission is carried out through a 
nationwide program of audits, investigations, inspections, sanctions, and fraud alerts.  The 
Inspector General informs the Secretary of program and management problems and recommends 
legislative, regulatory, and operational approaches to correct them. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of 
Inspector General.  It conducts short-term management and program evaluations (called 
inspections) that focus on issues of concern to the Department, the Congress, and the public.  The 
inspection reports provide findings and recommendations on the efficiency, vulnerability, and 
effectiveness of departmental programs. 
OEI's Boston Office prepared this report under the direction of Mark R. Yessian, Ph.D., Regional 
Inspector General.  Principal OEI staff included: 
REGION  HEADQUARTERS 
Russell W. Hereford, Ph.D., Project Leader  Alan Levine,  Program Specialist

Maria E. Maddaloni, M.A., Program Analyst  Barbara Tedesco, Mathematical Statistician

Linda Moscoe, Program Analyst

To obtain copies of this report, please call the Boston Regional Office at 617-565-1050. 
Reports are also available on the World Wide Web at our home page address: 
http://www.hhs.gov/oig/oei  E X E C U T I V E   S U M M A R Y  
PURPOSE 
To provide an early assessment of hospitals and organ procurement organizations 
responses to Medicare conditions of participation designed to increase organ donation. 
BACKGROUND 
More than 71,000 Americans are waiting for organ transplants, yet only 22,000 received 
organ transplants last year.  More than 6,000 people died while awaiting a transplant. 
As many as 15,000 deaths occur annually that could yield suitable donor organs.  Yet 
fewer than 6,000 of those deaths result in the donation of an organ. 
In June 1998, the Health Care Financing Administration (HCFA) changed the Medicare 
conditions of participation to spur an increase in donation.  In this report, we refer to this 
new condition as the donation rule.  The donation rule contains two key provisions: 
C  Hospitals must contact their organ procurement organization (OPO) in a timely 
manner about individuals whose death is imminent or who die in the hospital. 
C  Only OPO staff or trained hospital staff   referred to as designated requestors  
may approach families about organ donation. 
This report focuses on hospitals and OPOs early experiences with the donation rule.  We 
base our findings on a survey of all 61 OPOs; responses from 353 hospitals representing a 
stratified sample of Medicare-certified hospitals; site visits to 2 OPO service areas, where 
we interviewed hospital clinicians and administrators, OPO staff, and staff from tissue 
banks; and interviews with staff at 8 other OPOs. 
FINDINGS 
Hospitals and organ procurement organizations have made progress in 
implementing the donation rule. 
Hospitals are showing some improvement in their referral of potential organ donors. 
Two-thirds of OPOs reported an increase in the number of potential organ donors referred 
by hospitals. Based on our survey, we estimate that 40 percent of  hospitals nationally 
have seen an increase in the number of potential donors that they have referred to OPOs. 
1 
Organ Donation Rule  OEI-01-99-00020  OPOs are using the rule to increase the prominence given to organ donation within 
hospitals.  Nationally, 65 percent of hospitals are seeing an increase in their overall 
interaction with OPOs. 
OPOs are collecting data and providing feedback to hospitals on their performance 
in referring potential donors.  Most OPOs are performing routine death record reviews, 
which serve as the basis for feedback to hospital administrative, quality assurance, and 
clinical staff. 
However, OPOs and hospitals have not taken full advantage of the donation rule. 
OPOs resist using hospital staff to discuss organ donation with families.  Research 
shows that a collaborative approach between OPO staff and hospital staff yields the 
highest consent rates.  However, in our survey and site visits we found: 
<	 Limited training of designated requestors.  Only 22 of the 61 OPOs had trained 
designated requestors in more than 10 percent of their hospitals; 23 OPOs had 
trained none at all. 
<	 Tensions between physicians and OPOs.  Many physicians believe that the 
designated requestor provision intrudes on their right to practice medicine, because 
it requires that they must be trained by the OPO in order to discuss organ donation 
with their patients families. 
<	 Limited involvement of hospital staff.  Many hospital staff feel untrained or uneasy 
in approaching families to discuss donation. 
Hospitals are not consistently notifying their OPO of all deaths or imminent deaths. 
Our survey of OPOs and our site visits found that many hospitals are failing to notify their 
OPO of potential donors.  Only 2 OPOs responded that all hospitals are reporting all 
imminent deaths; 9 OPOs said that fewer than 25 percent of hospitals are reporting all 
imminent deaths. 
OPOs consider their relationship with hospitals to be collegial.  They resist taking 
forceful actions to ensure that hospitals notify them of all deaths or potential donors. 
OPOs stress professional education and internal hospital improvement.  They rarely use 
other strategies, such as publicizing hospital-specific performance data on donation and 
referral.  Even when hospitals fail to notify them of potential donors, OPOs indicated that 
they would not inform HCFA. 
Despite projections of a 10 percent increase, the number of organ donors rose by less 
than 1 percent in the first year of the donation rule.  The number of organ donors 
increased by only 44  from 5,807 in 1998 to 5,851 in 1999.  In 28 OPOs, the number of 
donors decreased in 1999.  Several factors may explain the shortfall between expectation 
and achievement.  One explanation may be that implementing a change such as this takes 
2 
Organ Donation Rule  OEI-01-99-00020  longer than originally anticipated.  A second factor may be the 1-year grace period that 
HCFA gave hospitals before enforcing the donation rule.  In addition, many OPOs already 
had voluntary referral programs with some hospitals in their service areas. 
HCFA does not obtain routine data to assess how well the donation rule is 
working. 
HCFA lacks a mechanism to assess the rules impact on organ donation.  Although 
OPOs collect data and provide feedback to hospitals on their performance, the 
organizations are not required to share these data with HCFA. 
HCFA lacks a proactive way to assess hospital compliance with the rule.  The agency 
does not require OPOs to submit either aggregate or hospital-specific data that it could 
use to assess the extent to which hospitals are complying.  Nor does it obtain routine 
information about OPOs efforts to collaborate with hospitals to implement the rule. 
HCFA relies on State certification agencies and the Joint Commission on 
Accreditation of Health Care Organizations to ensure hospitals compliance with the 
rule.  These surveys take place every 3 years, and donation activities encompass only a 
minor part of that review. 
RECOMMENDATIONS 
HCFA should revise the Medicare conditions for coverage for OPOs to make them 
more accountable for implementation of the donation rule. 
Because the donation rule is a Medicare condition of participation for hospitals, it places 
the obligation for compliance solely on hospitals, with no requirements for OPOs. 
Effective implementation of the rule requires accountability on behalf of OPOs as well as 
hospitals. 
HCFA should require OPOs to provide hospital-specific data on referrals and on 
organ recovery.  HCFA could utilize these data to assess hospital compliance with the 
donation rule, identify hospitals which are out of compliance with the conditions and, if 
appropriate, initiate corrective action.  These data should include relevant medical 
indicators and information on consent. 
HCFA should require OPOs to make hospital-specific data on donation publicly 
available.  Public information could encourage hospitals to work to maximize their 
participation in donation activities and would foster public discussion and education on 
donation. 
3 
Organ Donation Rule  OEI-01-99-00020  HRSA should require that OPOs, as members of the Organ Procurement and 
Transplantation Network, submit hospital-specific data on referrals and on organ 
recovery. 
Our recommendation to HCFA specifies the types of data elements which should be 
included.  In fact, in a proposed new contract to operate the OPTN, the Health Resources 
and Services Administration has proposed that the OPTN maintain such data.  Our 
recommendation is consistent with the proposed language in the renewal contract. 
HRSA, in its funding initiatives, should support demonstration projects on how to 
effectively train and make use of designated requestors. 
In 1999, HRSA funded $13 million in grant programs to OPOs and community groups. 
None of these programs addresses the role of designated requestors in the donation rule. 
In future funding solicitations, HRSA could give strong consideration to proposals to 
develop innovative programs for training designated requestors.  Such programs might 
include use of distance learning and computer-based training strategies. 
HRSA should develop an award that recognizes hospitals that demonstrate 
exemplary performance in donation. 
HRSA could work with HCFA and other agencies to develop criteria for this award, 
which would be an incentive for hospitals.  It could be based on the data submission we 
describe above, as well as other efforts, such as community education programs.  HRSA 
could issue the award during National Organ and Tissue Donor Awareness Week. 
COMMENTS ON THE DRAFT REPORT 
We received comments on our draft report both from within the Department and from 
external organizations.  We present the full text of the written comments in Appendix B. 
In the body of the report, we respond in full to all written comments.  Here, we describe 
the key points made in the comments.  For the external organizations, we also provide, in 
italics, a summary of our response. 
Comments from within the Department 
HCFA and HRSA provided written comments on our draft report, and the Office of the 
Assistant Secretary for Planning and Evaluation provided verbal comments.  These 
agencies responded positively to our report and recommendations. 
Comments from the Association of Organ Procurement Organizations 
Overall, AOPO disagrees with many of our findings and recommendations.  The 
4 
Organ Donation Rule  OEI-01-99-00020  association raises a number of points, but places particular emphasis on our findings and 
discussion about limited training and use of designated requestors. 
We base our finding about designated requestors on surveys of and discussions with the 
OPO and hospital communities.  We believe that these data sources provide balanced 
evidence.  We acknowledge the expertise of OPO staff in working with families. 
However, at an organizational level, we found a number of practices that indicate OPO 
resistance to training and using hospital staff as designated requestors.  It is because of 
the concerns we identified that we recommend that HRSA support projects on how to 
effectively train and use designated requestors. 
Comments from the American Hospital Association 
Overall, AHA raises concerns about our recommendations related to increased reporting 
of hospital-specific data on donation.  The association believes that the full freight of 
increasing organ donation nationwide cannot and should not rest on a regulatory 
solution. 
Our recommendations proceed from the underlying assumption that data measurement 
forms the basis for performance improvement.  In our efforts to determine the extent to 
which hospitals are complying with this Medicare condition of participation, and the 
extent to which organ donation has changed in response to it, it was readily apparent to 
us that timely data are not available on a voluntary basis.  It is for this reason that we 
recommend that HCFA require the submission of such data. 
5 
Organ Donation Rule  OEI-01-99-00020  T A B L E  O F  C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

PRIMER ON ORGAN DONATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11

FINDINGS

Progress being made  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

OPOs and hospitals have not taken full advantage  . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

HCFA lacks data to assess the donation rule  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Only slight increase in number of donors  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

RECOMMENDATIONS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21

RESPONSE TO COMMENTS ON THE DRAFT REPORT . . . . . . . . . . . . . . . . . . . . . . .  25

APPENDICES

A:  Methodology  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

B:  Comments on the Draft Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

C:  Endnotes  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

6 
Organ Donation Rule  OEI-01-99-00020  I N T R O D U C T I O N  
PURPOSE 
To provide an early assessment of hospitals and organ procurement organizations 
responses to Medicare conditions of participation designed to increase organ donation. 
BACKGROUND 
More than 71,000 Americans are waiting for organ transplants, yet only about 22,000 
received organ transplants last year.  More than 6,000 people died while awaiting an organ 
transplant.  An estimated 12,000 to 15,000 deaths occurring in the United States every 
year could yield suitable donor organs.  However, fewer than 6,000 of those deaths result 
in the donation of an organ.1 
Organ donation requires close coordination and support among organ procurement 
professionals, hospital and medical personnel, and grieving families.  On page 11, we 
present a primer that provides an overview of organ donation. 
The Departments Role in Organ Donation 
Health Care Financing Administration (HCFA).  HCFA carries out several important 
responsibilities with respect to organ procurement.  The agency specifies organ 
procurement service areas and certifies organ procurement organizations (OPOs) for 
participation in Medicare.  HCFA, through the Medicare program, provides funding for 
organ procurement organizations. 
Medicare covers organ transplantation for Medicare beneficiaries.  Of special note is 
Medicare coverage for kidney transplantation.  End Stage Renal Disease is unique, in that 
it is the only disease-specific condition that qualifies someone for Medicare coverage, 
regardless of age.  That coverage includes kidney transplantation. 
HCFA also determines the conditions of participation for hospitals, including their 
interactions with OPOs. 
Health Resources and Services Administration (HRSA).  HRSAs Division of 
Transplantation provides Federal oversight and support for the organ procurement, 
allocation, and transplantation system.  HRSA funds the Organ Procurement and 
Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients 
(SRTR).  The contract for both of these operations is currently held by the United 
7 
Organ Donation Rule  OEI-01-99-00020  Network for Organ Sharing, a nonprofit organization based in Richmond, Virginia. 
The OPTN is charged with operating and monitoring an equitable system for allocating 
organs, maintaining a waiting list of potential recipients, matching potential recipients with 
organ donors, and increasing organ donation.  All organ procurement organizations and 
transplant programs are members of the OPTN.  The SRTR is a database on recipients of 
solid organ transplants; the database supports ongoing evaluation of the scientific and 
clinical status of transplantation. 
HRSA also is responsible for national coordination of organ donation activities, the 
funding of grants and special initiatives to learn more about what works to increase 
donation, and technical assistance to OPOs and other transplant-related entities.  For 
example, HRSA conducts national technical assistance workshops that bring together staff 
from OPOs and hospitals to address implementation of the donation rule, and to identify 
and share effective practices in collaboration. 
The National Organ and Tissue Donation Initiative.  In response to the need for organ 
donors, the Secretary launched this initiative in December 1997.  The goals of the 
initiative are to increase consent to donation, maximize donation opportunities, and learn 
more about what works to increase donation and transplantation through carefully 
designed research efforts.2 
Organ Procurement Organizations 
Each OPO serves a defined geographic area.  The population in an OPOs service area 
ranges from just over 1 million people to more than 11 million people.  At the end of 
1999, 61 OPOs were in operation.3  HCFA certifies OPOs for two years.  HCFA measures 
OPO performance on five standards related to organ procurement.4 
Every hospital has an agreement with one OPO.  OPOs work with medical professionals 
and the public to encourage organ donation.  They provide the services necessary to 
coordinate the identification of potential organ donors, requests for donation, and 
recovery and transport of organs. 
The Donation Rule:  Medicare Conditions of Participation for Organ, Tissue, and 
Eye Donation 
HCFA published the final rule on Medicare conditions of participation for organ, tissue, 
and eye donation as part of the National Organ and Tissue Donation Initiative.  The rule 
became effective August 21, 1998.5  The donation rule was based on a 1994 Pennsylvania 
law requiring hospitals to report all deaths to the OPO.  The OPO in eastern Pennsylvania 
saw a 40 percent increase in organ donation in the first two years of operation, compared 
to an average increase of 3 percent nationally. 
8 
Organ Donation Rule  OEI-01-99-00020  In this report, we refer to these conditions of participation as the donation rule.  The 
rule imposes several requirements that are designed to increase organ donation.6  The 
donation rule mandates that each hospital must contact its OPO in a timely manner about 
individuals whose death is imminent or who die in the hospital.  The OPO then determines 
the individuals medical suitability for organ donation.  Because the hospital notifies the 
OPO of each death or imminent death, the rule is intended to ensure that the family of 
every potential donor is informed of its option to donate organs, tissues, or eyes. 
The donation rule also strengthens the role of OPOs in the donation process.  It requires 
that families be advised of their donation options by an OPO representative or a 
designated requestor trained by the OPO.  A designated requestor is defined in the 
donation rule as an individual who has completed a course offered or approved by the 
OPO in the methodology of approaching potential donor families and requesting organ 
donation. 
The designated requestor requirement is based on research showing that consent for organ 
donation is highest when the following practices are observed: 
C  The family members are given time to understand and accept their relatives death 
before the organ donation request is made; 
C  The request is made by the OPO coordinator and a member of the hospital staff 
together; 
C  The request is made in a quiet, private setting.7 
Importance of Collaboration between Hospitals and OPOs 
The critical piece to making these provisions work is collaboration and cooperation 
between hospitals and OPOs in identifying and managing potential donors and in obtaining 
consent from donor families.  Hospitals and OPOs both have important roles to play in 
increasing donation.  Hospitals must refer and manage donors; OPOs must train hospital 
staff on how to identifying and manage potential donors, and on how to request consent. 
The donation rule encourages the use of best practices, based on research that indicates 
that consent to organ donation is highest when the formal request is made by OPO and 
hospital staff together. 
This Inquiry 
This report focuses on hospitals and OPOs early experience with the donation rule.  We 
evaluate the progress OPOs and hospitals are making in implementing the donation rule, 
as well as obstacles encountered in implementation.  This report focuses on the provisions 
of the rule relating to organ donation, not tissue and eye donation. 
9 
Organ Donation Rule  OEI-01-99-00020  METHODOLOGY 
We surveyed the executive directors of the 61 organ procurement organizations in 
October 1999, with a 100 percent response rate.  We also visited two OPO service areas. 
In each service area, we met with OPO staff, hospital staff (nurse managers, 
administrators, physicians, nurses, and quality assurance personnel), and tissue bank staff. 
In addition, we conducted in-depth interviews with staff from 8 OPOs to learn more about 
their experiences with the donation rule. 
We surveyed a stratified sample of Medicare-certified hospitals in February 2000, to learn 
more about their early experiences in implementing the donation rule.  We stratified the 
sample by size: small hospitals (100 beds or fewer), medium (101 to 299 beds), and large 
(300 beds or more).  We received usable responses from 353 hospitals, 78 percent of the 
total surveyed.  Appendix A contains confidence intervals for the estimates derived from 
this survey. 
We also spoke with staff from other organizations with interest in the donation rule, such 
as the Association of Organ Procurement Organizations and the American Hospital 
Association.  Appendix A contains a detailed description of our methodology. 
We conducted this inspection in accordance with the Quality Standards for Inspections 
issued by the Presidents Council on Integrity and Efficiency. 
10 
Organ Donation Rule  OEI-01-99-00020  P R I M E R   O N   O R G A N   D O N A T I O N  
The Process of Donation 
1.  Identifying a Potential Organ Donor. Organ donors appear at unpredictable times, most often from 
tragic circumstances, such as an automobile accident, gunshot wound, or other trauma that causes 
irreversible damage to the central nervous system. Upon admission to a hospital, the individual may be 
maintained for up to several days on a ventilator, a machine that provides artificial life support for 
breathing and respiratory function. 
2. Notifying the Organ Procurement Organization (OPO). The hospital notifies its OPO about the 
individual who has died or whose death is imminent. OPO staff obtain information needed for a 
preliminary assessment of that individuals medical suitability as an organ donor. 
3.  Managing the Donors Care. Medical, hospital, and OPO personnel monitor the individuals progress 
and maintain vascular organ function through medical treatment. 
4.  Determining and Declaring Brain Death. Physicians conduct tests to determine whether the individual 
is brain dead. If brain death is confirmed, a physician declares death. Brain death is the complete and 
irreversible loss of all brain function. Brain death can be determined through tests that include an 
electroencephalogram (EEG) to determine the absence of electrical activity in the brain, blood flow studies 
to determine the absence of blood flowing to the brain, or clinical assessment (no movement, no response to 
stimulation, no breathing, no brain reflexes) to determine the absence of function in all parts of the brain. 
5.  Requesting Consent.  A trained OPO staff member or a hospitals designated requestor asks the 
individuals family members for consent to donate their relatives organs. Even if the individual had 
indicated willingness to donate organs (e.g., on the drivers license), it is practice in this country to obtain 
consent from the next-of-kin. A family may refuse to give consent, or it may give consent for donation of 
all or only some organs. 
6. Recovering Organs. If the family consents to donation, the organs are removed in an operating room 
in a sterile surgical procedure. 
7. Transporting Organs for Transplantation. The organs are shipped immediately to the transplant 
hospital(s) where patient(s) awaiting a transplant receive them. 
Key Terms in Organ Donation 
Organ. Transplantable organs include the heart, liver, lungs, kidneys, pancreas, and intestines. 
Imminent Death. Imminent death is defined under hospital policies devised in conjunction with its OPO. 
Imminent death generally includes a severely brain-injured individual on a ventilator. 
Designated Requestor.  A designated requestor is an individual who has completed a course offered or 
approved by the OPO in the methodology for approaching potential donor families and requesting organ 
donation. 
11 
Organ Donation Rule  OEI-01-99-00020 F I N D I N G S  
Hospitals and organ procurement organizations have made progress 
in implementing the donation rule. 
Hospitals are showing some improvement in their referral of potential organ 
donors. 
In response to our survey, 40 of the 61 OPOs reported an increase in the number of 
potential organ donors referred by hospitals since the rule took effect; 38 OPOs noted that 
the timeliness of hospital referrals had improved.  Hospitals responses support those of 
the OPOs.  Based on the results from our survey of hospitals, we estimate that 40 percent8 
of hospitals nationally have seen an increase in the number of imminent deaths they 
referred to OPOs.  The impact of these changes was exemplified by donation coordinators 
we met with at one OPO.  They told us that prior to the rule, they received 40-50 calls per 
month about potential donors, but now they were receiving over 100 calls per month. 
In addition to the overall increase in referrals, it is noteworthy that there is improvement 
among hospitals with little prior involvement in organ donation.  According to 26 OPOs, 
organ donation occurred in hospitals that had not provided organ donors previously; 
23 OPOs reported an increase among those hospitals that had provided organ donors only 
occasionally. 
We found that fewer small hospitals  those with 100 or fewer beds  had an increase in 
the number of imminent deaths referred to the OPO (p<.01).  Among the small hospitals, 
28 percent saw an increase in referral of imminent deaths, compared with 51 percent of 
mid-size hospitals (101- 299 beds), and 57 percent of hospitals with 300 or more beds. 
OPOs are using the rule to increase the prominence given to organ donation 
within hospitals. 
OPOs are taking advantage of the donation rule to increase their presence in hospitals. 
Nationally, we estimate that 65 percent of hospitals are seeing an increase in their overall 
interaction with the OPO since the rule went into effect.  In 36 percent of hospitals the 
presence of OPO staff in the hospital has increased, and in 47 percent the OPO is more 
responsive to their concerns. 
This increased leverage results from linking referral of organ donors to the Medicare 
conditions of participation.  Previously, a hospitals involvement in donation depended to 
a large extent on the persuasiveness of OPO staff and the comitment of key clinicians and 
12 
Organ Donation Rule  OEI-01-99-00020  administrators.  With the advent of the donation rule, hospitals face review of their 
participation in organ donation by the Joint Commission on Accreditation of Health Care 
Organizations and State survey agencies.  One OPO staff member summarized this impact 
when she said that Prior to the rule we came in at the hospitals invitation.  Now we have 
serious clout; we can encourage dialogue and collaboration. 
The increased interaction with the OPO also has led to increased awareness among 
hospital staff about donation.  We found this to be the case among smaller hospitals in 
particular.  In their qualitative responses to our survey, many cited this increased 
knowledge among their staff as a benefit of the donation rule. 
OPOs are collecting data and providing feedback to hospitals on their 
performance in referring potential donors. 
Feedback is a key tool that the OPO staff use to work with hospitals on increasing 
donation.  In response to our survey, 57 OPOs reported that they conduct death record 
reviews to verify hospitals reporting of deaths and imminent deaths.  52 OPOs reported 
that they also reviewed hospitals death logs.  These reviews serve as the basis for the 
feedback that OPO staff give to hospital administration and quality assurance committees 
about a hospitals compliance with the rule. 
In addition to this formal reporting structure, OPO staff provide feedback to the key units 
in the hospital, such as the intensive care unit, the emergency department, and other areas 
in which ventilator-dependent patients receive care.  A good portion of OPO staff time is 
devoted to working with key nurses and physicians on these units.  For example, staff at 
one hospital we visited told us that its quality assurance committee holds a conference 
after each referral for organ donation.  These meetings, held with OPO staff, are used to 
determine what worked well, and where future improvements could be made. 
OPO feedback emphasizes two points that help guide OPOs education and training 
agenda for hospital staff.  The first point relates to missed potential donors, i.e., those 
who were never identified or about whom the OPO never received notification.  In these 
cases, educational efforts focus on identifying and referring potential donors. 
The second point relates to potential donors who were identified, but for whom the family 
did not give consent.  For example, the hospital staff may have approached the family 
without involving the OPO at the appropriate time.  Feedback to the hospital staff in this 
type of situation would focus on the need for timely OPO involvement in approaching 
families about donation. 
13 
Organ Donation Rule  OEI-01-99-00020  However, OPOs and hospitals have not yet taken full advantage of the 
donation rule. 
OPOs resist using hospital staff to discuss organ donation with families. 
Research shows that a collaborative approach between OPO staff and hospital staff yields 
the highest consent rates.  However, in our survey and site visits we found: 
Limited designated requestor training.  Our survey found that 23 of the 61 OPOs had 
trained no designated requestors at all; only 22 OPOs had trained designated requestors in 
more than 10 percent of the hospitals in their service area.  Based on our survey of 
hospitals, we estimate that 70 percent of hospitals had been offered designated requestor 
training by their OPO.  But staff in only 44 percent of hospitals had, in fact, been trained. 
We heard of situations in which training programs were not marketed widely to hospitals, 
and situations in which the OPO made it difficult for hospital staff to attend  for 
example, holding a 3-day training program in a city that is several hundred miles away 
from some hospitals.  In some cases, OPOs have established only a standard, one-size-fits-
all program, lacking the flexibility to respond to the varying needs of hospitals or different 
types of providers, such as physicians and nurses. 
Tensions between physicians and OPOs.  Many physicians believe that the designated 
requestor provision intrudes on their right to practice medicine.  Undoubtedly, tensions 
existed between OPOs and physicians prior to the rule.  But stipulating that physicians 
cannot discuss organ donation with families unless they have received designated 
requestor training from the OPO exacerbates these tensions. 
During our site visits we met with a number of physicians from hospital units in which 
there are potential organ donors, such as pediatric and adult intensive care units and 
trauma services.  All were vehement about this provision, telling us that it puts them in a 
very awkward position with the family of a potential donor.  One physician exemplified 
these feelings when he told us, It is distasteful to call the OPO to meet with the family. 
This hospital has an open policy of working closely with families, and parents are involved 
in the care of their children.  I hold nothing back from them; they are there at all 
procedures. Why am I not good enough to speak to them about organ donation? 
Limited involvement of hospital staff.  Among hospital staff, the designated requestor 
requirement may be leading to an unintended result.  Rather than moving toward a 
collaborative approach to requesting consent, this provision runs the very real risk of 
turning consent into an OPO function, with little involvement from hospital staff.  Our 
survey responses from hospitals and our visits with them supported this finding.  Several 
of the qualitative responses to our hospital survey indicated that their staff were happy to 
14 
Organ Donation Rule  OEI-01-99-00020  turn requesting donation over to the OPO, because the hospital staff felt untrained and 
uncomfortable in approaching families. 
Controlling the consent process.  OPOs have little incentive to train hospital-based 
designated requestors.  OPOs cite their training and experience, as well as the time their 
staff are able to spend with the family as reasons for a higher consent rate.  They can focus 
solely on donation and family concerns (whereas hospital staff must care for other patients 
on the unit).  As one OPO staff member explained, Gaining a familys consent is a 
process, not a one-time thing.  It takes a long time to discuss options, answer all their 
questions, answer questions that the family hasnt even asked.  OPO staff cite their 
continuing experience and practice in approaching families, something that a trained 
designated requestor would not possess, even in a hospital with a large number of donors. 
At an organizational level, OPOs have a pragmatic reason for maintaining control.  The 
OPOs feel that they  not hospitals  are responsible for meeting the minimum 
standards required to maintain their Medicare certification.9  Therefore, they believe that it 
is in their best interests to be in complete control of the process of obtaining consent. 
Implications.  The implications of OPO reluctance to train designated requestors are 
multiple.  First, if the requirements really do lead to separation of the OPO and hospital in 
obtaining consent, the positive impact of a collaborative approach to the family will be 
lost.  Second, in hospitals that are geographically distant from the OPO, no one may be 
available with any knowledge about donation when the time comes to speak with a family. 
Even if the hospital contacts the OPO early in the process, distance may prevent the staff 
from getting to the hospital on time.  In these cases, the opportunity to request consent 
may be lost, simply because no one is able to raise the issue. 
The lack of OPO training for designated requestors raises a fundamental conflict:  It is up 
to the hospital to determine who may approach a family to request.  The rule requires that 
The individual designated by the hospital to initiate the request to the family must be an 
organ procurement representative or a designated requestor.  A designated requestor is an 
individual who has completed a course offered or approved by the OPO.10  However, if 
the OPOs are not training hospital staff to become designated requestors, then the hospital 
has no option but to use the OPO staff.  This directly contradicts research showing that a 
collaborative effort between hospitals and OPOs is the most effective way of obtaining 
family consent to donation. 
An even more far-reaching problem may be the gradual disenfranchisement of hospital 
staff from involvement in organ donation.  To the extent that nursing and other hospital 
staff see organ donation as the OPOs job, one in which the hospital staff should have 
no involvement, there is likely to be little true collaboration or interest in organ donation. 
15 
Organ Donation Rule  OEI-01-99-00020  Hospitals are not consistently notifying their OPO of all deaths or imminent 
deaths. 
Many hospitals are moving forward to implement the donation rule; however, OPOs have 
not had complete success in working with hospitals toward implementation.  Successful 
implementation is not something that the OPO can do on its own.  After all, the rule is a 
hospital condition of participation, and it requires a great deal of commitment, initiative, 
and cooperation among the various parties involved. 
According to the OPOs, hospitals are not notifying them of all imminent deaths.  In our 
survey, only 2 OPOs responded that all hospitals are reporting all imminent deaths; 
9 OPOs said that fewer than 25 percent of hospitals are reporting all imminent deaths. 
During our site visits, we reviewed detailed data from 1999 on imminent death reporting 
in three hospitals.  These hospitals failed to report 43 percent, 29 percent, and 14 percent 
of the imminent deaths. 
From our observations, we identified three key challenges that hospitals face in taking full 
advantage of these provisions. 
Internal Hospital Leadership.  In many hospitals, organ donation may be relatively low 
on the priority scale; it is just one of many things for which hospitals are responsible. 
Where donation is working well, there tends to be a champion who has taken the donation 
cause under his or her wing and who is leading the charge within the hospital.  This 
leadership may come from administrative, nursing, or medical personnel (or, preferably, all 
three).  Comments from two hospital administrators exemplify this point.  In a hospital 
that had been struggling with organ donation, the administrator told us, No one is really 
willing to wrap their arms around organ procurement.  In a hospital that was 
encountering success with donation, the executive said, You really need an individual in 
the hospital to be committed to this. You need an avid supporter. 
Physician Resistance.  Above, we discussed the difficulty that the designated requestor 
provision poses for some physicians.  Other concerns of physicians affect how the 
donation rule is implemented.  In some hospitals, administrators may be reluctant to 
challenge medical staff who resist implementing the rule and have adopted a hands-off 
attitude toward these physicians. 
We heard consistently about the need for creative ways to inform the OPO of donor 
candidates by going around the back of the physicians to call the OPO.  At one hospital 
(which had more than 20 organ donors  a relatively large number  in 1999), a nurse 
on the intensive care unit told us that Physicians resent nurses notifying the OPO, so 
often we do it behind the scene. Elsewhere, a nurse told us, Most of the staff wait for 
the doctor to code the patient [declare the patient brain dead] before calling the OPO. 
16 
Organ Donation Rule  OEI-01-99-00020  These instances of reluctance to contact the OPO early in the process occurred in hospitals 
with a large number of donors; undoubtedly, the problem is more severe in hospitals with 
fewer donors. 
Cumbersome Operational Procedures.  In some hospitals it is not clear who will call the 
OPO in the case of a patient whose death is imminent.  Some hospitals have interpreted 
these provisions to mean that only a nursing supervisor can phone the OPO.  Other 
hospitals have interpreted the provisions to mean that only someone who has gone 
through the OPO-sponsored designated requestor training may notify the OPO. 
OPOs consider their relationship with hospitals to be collegial.  They resist taking 
forceful actions to ensure that hospitals notify them of all deaths or potential 
donors. 
In our work on external quality oversight of health care providers, we have found it 
helpful to consider oversight efforts in terms of a continuum, characterized by a collegial 
approach on one side and a regulatory approach on the other.  External reviewers in the 
collegial mode focus on educating and improving performance; those in a regulatory mode 
focus on investigating and enforcing minimum requirements.11 
This continuum also is a useful way of viewing the relationship between OPOs and 
hospitals.  As they currently operate, OPOs fall on the collegial, rather than regulatory, 
side of this continuum.  OPO staff note that they are invited into a hospital at the 
hospitals request, that they approach the hospital staff and physicians as professionals for 
peer education, and that their work with hospitals focuses on continuous process 
improvements, not on enforcement of minimum standards.  Staff from OPOs we 
interviewed emphasized that it is HCFAs job  not the OPOs  to enforce any 
noncompliance by hospitals. 
However, the OPOs do not facilitate HCFAs ability to ensure compliance with the rules 
provisions.  Only two OPOs indicated that they would inform HCFA about poor 
compliance by hospitals with the rules notification requirements.  The OPOs strongly 
reject any enforcement role.  In their qualitative responses to our survey, typical comments 
from OPOs included concern of OPOs acting as a policemen  should not put OPOs in 
that position, and threat of HCFA punishment puts OPO in the position of tattling which 
impacts our working relationships negatively. 
Rather, OPOs stress collegiality.  When we asked OPOs about how they respond to a 
hospital that failed to notify them of all deaths or imminent deaths, 59 responded that they 
conduct additional training, 55 that they meet with hospital administration, and 47 that 
they provide feedback to the hospital quality assurance department.  OPOs cited educating 
hospital staff, meeting with physicians, establishing donor awareness teams, and working 
with the hospital liaisons as their preferred strategies. 
17 
Organ Donation Rule  OEI-01-99-00020  Although OPOs have data and provide detailed feedback to hospital units, as we showed 
above, we found them extremely reluctant to provide hospitals with comparative data on 
their performance in organ donation.  Staff we spoke with from hospitals that had 
increased donation took great pride in that fact.  Most OPOs, however, do not release 
these data or share them with other institutions.  However, at least one OPO  apparently 
the exception   does release these data, which include total referrals, organ referrals, 
organ donors, tissue referrals, and tissue donors.12 
HCFA does not obtain routine data to assess how well the donation 
rule is working. 
HCFA lacks a mechanism to assess the rules impact on organ donation. 
OPOs gather data that could be used to help determine the rules impact on organ 
donation.  These data could provide information to determine the success of efforts to 
increase donation and guide future initiatives.  OPOs gather data on the number of 
hospital deaths, number of imminent deaths, potential candidates for donation, families 
approached for consent, and outcome of requests for consent.  Indeed, these data form the 
basis of feedback that OPOs give to the hospitals in their service areas. 
OPOs, however, consider these data to be confidential information.  They do not share the 
data with HCFA either at a hospital-specific level, or even at an aggregate OPO level. 
The only data that HCFA currently receives from OPOs are in an annual report on the 
total number of organ donors, number of kidneys procured and transplanted, and number 
of extra renal organs procured and transplanted.  HCFA uses these data in its biennial 
OPO certification process to assess OPO performance in obtaining donors. 
HCFA lacks a proactive way to assess hospital compliance with the rule in a 
timely manner. 
OPOs collect data on the number of notification calls that hospitals make and how many 
they fail to make, based on the results of death record reviews.  They also collect data on 
the rate of consent for donation.  Again, however, HCFA does not require OPOs to share 
these data with the agency in a way that could be used to assess hospital compliance with 
the rule on an ongoing basis. 
The primary mechanism that HCFA uses to gather ongoing, timely information is its staff 
in the field.  When the donation rule was promulgated, HCFA named four regional 
coordinators to work on implementing the regulation.  These coordinators have been 
responsible for responding to calls and questions from OPOs and hospitals regarding 
implementation of the rule, and for training State surveyors.13 
18 
Organ Donation Rule  OEI-01-99-00020  Hospitals and OPOs may contact the coordinators when conflicts or problems develop. 
By its very nature, however, this arrangement is reactive.  Furthermore, the coordinators 
are caught in a conflict between their efforts to provide technical assistance to hospitals 
and OPOs, versus the hospitals and OPOs perception of their role as regulators. 
HCFA relies on State certification agencies and the Joint Commission on 
Accreditation of Health Care Organizations to ensure hospitals compliance with 
the rule. 
The Joint Commission and State survey and certification agencies assess compliance with 
all Medicare conditions of participation through their survey process.  However, the 
interval between these surveys is lengthy.  Hospitals accredited by the Joint Commission 
are surveyed every 3 years.14  State agencies conduct certification surveys even less 
frequently; as of late 1997, fully half of the nonaccredited hospitals had not had a survey 
within three years.15 
Furthermore, standards assessing the donation rule comprise a small part of accreditation 
and certification surveys.16  Several hospitals we visited had been surveyed by the Joint 
Commission prior to our visit.  Staff at some of these hospitals told us that they had been 
asked only to show surveyors their policies and procedures governing organ donation. 
One hospital, which was not scheduled to have a Joint Commission visit for another year 
and a half, still did not have its policies and procedures in place. 
Despite the reported increase in referrals, the number of organ donors 
increased by less than one percent in the first year of the donation 
rule. 
Nationally, the number of organ donors increased by only 44, from 5,807 in 1998 
to 5,851 in 1999. 
The Department projected that the donation rule would lead to a 20 percent increase in 
donation over a 2-year period, 10 percent in each of the first two years.17  This projection 
was based on the results of the Pennsylvania law, under which the OPO in eastern 
Pennsylvania saw a 40 percent increase in the first two years of operation.  However, the 
results of the first full calendar year18 of HCFAs donation rule fell far short of that 
expected progress. 
Not only did the total number of donors increase only marginally, but 28 OPOs also had 
fewer donors in 1999 than in 1998.  In 19 of these 28 OPOs, the decrease was greater 
than 10 percent, and greater than 20 percent in 4 of them.  In 31 OPOs, there was an 
increase in the number of donors procured in 1999. 
19 
Organ Donation Rule  OEI-01-99-00020  There may be some plausible explanations for the small increase in the first year of 
operation of the donation rule.  One explanation may simply be that the time required to 
implement a change such as this is longer than originally anticipated. 
A second explanation may lie in the 1-year grace period that HCFA gave hospitals.  HCFA 
informed hospitals that they would not be held to compliance with the rule for the first 
year.  However, hospitals were expected to be working with their OPOs to achieve full 
implementation of the rule.  It is likely that some hospitals were not moving towards 
implementation.  In fact, we saw evidence of this slow progress during our site visits. 
Third, many OPOs already had voluntary routine referral programs with at least some 
hospitals in their service areas, and others operated in States with laws requiring referrals 
of deaths and imminent deaths.  Consequently, these OPOs may already have achieved 
some of the increase that HCFA had projected.  These laws and arrangements, however, 
do not contain any provisions analogous to the designated requestor requirement in the 
HCFA rule. 
Responses to our survey showed that 48 out of 61 OPOs had voluntary referral 
arrangements with at least some hospitals in their service areas.  Under these 
arrangements, a hospital notified the OPO of deaths that occurred in the hospital.  These 
arrangements varied; in some cases hospitals reported all deaths, in others they excluded 
deaths over a certain age or with certain diseases.  We estimate that 51 percent of 
hospitals nationally had voluntary arrangements with their OPO prior to the donation rule. 
Some States, such as Pennsylvania, had enacted laws requiring hospitals to refer donors to 
the OPO.  The OPOs responding to our survey indicated that 16 States have these 
required referral laws.19  Like the voluntary arrangements (but unlike the HCFA rule), 
these laws often exclude from the reporting requirements deaths of patients with certain 
diagnoses or above a minimum age.  Significantly, though, the two OPOs in Pennsylvania 
 where the State law serves as the model for the HCFA rule  reported large increases 
in 1999; one OPO had 38 more donors (26 percent increase) and the other OPO had 33 
more donors (11 percent increase). 
20 
Organ Donation Rule  OEI-01-99-00020  R E C O M M E N D A T I O N S  
Increasing organ donation is a high-priority national objective.  More than 71,000 
seriously ill Americans are waiting for an organ; in 1999, more than 6,000 died while 
awaiting an organ.  The need for organs for transplantation is reflected in national policies, 
such as the National Organ Transplant Act, Medicare coverage for renal failure, and 
broad-based educational efforts.  These efforts are clear evidence that enhancing donation 
cannot be left to the vagaries of local performance. 
HCFAs new Medicare conditions of participation for organ, tissue, and eye donation are 
such an initiative.  This donation rule, promulgated in 1998, aims to give OPOs better 
access to hospitals and to potential organ donors therein.  Our analysis is an early 
implementation study of that donation rule. 
Although we found some early signs of progress in improving referrals, we also found 
signs that difficulties lie ahead in realizing the donation rules potential.  In particular, we 
found problems in the rules provision to improve the methods for obtaining family 
consent through designated requestors; the lack of data available to HCFA to assess the 
effects of the regulation and how hospitals and OPOs are responding to it; and the 
disappointing increase in organ donation during the first year of implementation. 
We offer the following recommendations as ways of increasing organ donation by helping 
to enhance the operations of the new donation rule.  Both HCFA and HRSA have critical 
roles to play in maximizing the impact of the donation rule.  HCFA sets the conditions 
under which both OPOs and hospitals participate in the Medicare program; HRSA 
oversees the OPTN contract and supports education to increase organ donation. 
HCFA should revise the Medicare conditions for coverage for OPOs to make them 
more accountable for implementation of the donation rule. 
Our guiding principle underlying this recommendation is straightforward:  Maximizing 
organ donation requires coordination and collaboration between hospitals and OPOs.  The 
donation rule, however, is contained in the Medicare conditions of participation for 
hospitals.  While it provides OPOs with significant leverage that they can use to work 
with hospitals on donation, the rule places the obligation for compliance solely on 
hospitals; it sets no requirements for the OPOs.  Effective implementation of the donation 
rule requires accountability on behalf of both OPOs and hospitals. 
<<	 HCFA should require OPOs to provide hospital-specific data on referrals and on 
organ recovery. 
We found that HCFA lacks a mechanism to assess the rules effect on donation and that 
21 
Organ Donation Rule  OEI-01-99-00020  the agency lacks a proactive way to assess hospitals compliance with it.  The most 
effective and efficient way of reaching these goals is to obtain data through the OPOs. 
The rule requires that hospitals notify their OPO of all patient deaths and patients whose 
deaths are imminent.  Therefore, the OPOs have the necessary data readily available.  We 
do not envision the need for data beyond what OPOs currently collect. 
OPOs should submit these data for all deaths or patients whose deaths are imminent in a 
hospital.  One way in which the data could be collected and aggregated would be via OPO 
submission to the Organ Procurement and Transplantation Network. 
At a minimum, these data should include: 
C  Demographic information, such as hospital name, age of patient, and date of call; 
C  Relevant medical indicators, such as whether the patient was on a ventilator, the 
causes/ circumstances of death, and diagnoses that preclude organ donation; 
C  Consent information, such as whether a request for organ donation was made, 
whether the request was made by OPO or hospital staff, whether consent was 
given, and whether organs were recovered; and 
C  The total number of deaths and imminent deaths in each hospital, and the number 
for which the OPO never received notification, or received notification after the 
ventilator had been disconnected. 
To make these data useful, HCFA should require that OPOs submit timely and accurate 
information.  In fact, we believe that these data are sufficiently important for HCFA to 
include their timely and accurate submission in its OPO performance measures.  In our site 
visits, we found that OPOs have these data readily available; in some cases, the data are 
shared with hospitals on a weekly basis.  We believe that OPOs could reasonably, 
inexpensively, and easily provide current data on a quarterly basis. 
HCFA could use these data for three purposes.  First, the data would provide a basis upon 
which HCFA and the Department could assess the effectiveness and impact of efforts to 
increase organ donation. 
Second, HCFA could use these data in the OPO certification process.  The OPO 
community has raised concerns that current performance standards fail to reflect variation 
among OPOs in the potential donor pool.  Some OPOs argue that their true potential 
donor pool is smaller than that in other service areas, due to local factors such as 
differences in the cause of death and population mix.  We believe these data could be used 
to shed light on these differences and to begin to identify regional variation in the potential 
donor pool. 
Third, HCFA could use these data to assess hospital compliance with the conditions of 
participation.  Having these data available would enable HCFA to identify and deal with 
22 
Organ Donation Rule  OEI-01-99-00020  noncompliant hospitals, rather than place that burden on the OPOs. 
<<	 HCFA should require OPOs to make hospital-specific data on donation publicly 
available. 
The data that an OPO has about hospitals performance on organ donation could be made 
available for publication in local newspapers or on the Internet.  As we note above, at least 
one OPO already publishes these data in its annual report. 
One important goal in making such data publicly available is to hold hospitals more 
accountable for their performance in referring organ donors.  We also know, however, 
that some parties may raise concerns that the data would be misinterpreted.  We have 
heard concerns that patients might avoid a hospital that provides a large number of 
donors, out of fear that the hospital would be more interested in procuring their organs 
than in saving their lives.  Contrary to those concerns, we believe that making these data 
publicly available would foster public discussion and education about the need for organs 
and could, indeed, spur donation. 
HRSA should require that OPOs, as members of the Organ Procurement and 
Transplantation Network, submit hospital-specific data on referrals and on organ 
recovery. 
Organ procurement organizations are members of the OPTN, the private entity 
responsible for day-to-day operation of the national system for distributing organs.  HRSA 
should require that the OPOs submit to the OPTN, and that the OPTN maintain, data on 
deaths and imminent deaths in hospitals. 
Our recommendation to HCFA specifies the types of data elements which should be 
included.  In fact, in a proposed new contract to operate the OPTN, HRSA has proposed 
that the OPTN maintain such data.  Our recommendation is consistent with the proposed 
language in the renewal contract. 
HRSA, in its funding initiatives, should support demonstration projects on how to 
effectively train and make use of designated requestors. 
In 1999, HRSA awarded $13 million in grant programs to OPOs and community groups. 
None of these programs addresses the role of designated requestors in the donation rule. 
In future funding solicitations, HRSA could give strong consideration to proposals to 
develop innovative programs for training designated requestors.  For example, to address 
issues of long distance access to training programs, HRSA might encourage the use of 
innovative technologies, such as computer-based training strategies. 
It will be particularly important to pay attention to the role of physicians in discussing 
23 
Organ Donation Rule  OEI-01-99-00020  organ donation with families.  The designated requestor provision has brought concerns 
about that role to the forefront.  In a hospital setting, physicians are major influences in 
medical decisions, such as those surrounding organ donation.  Many physicians believe 
that they are in the best position to discuss donation with, and obtain consent from, family 
members; OPO staff cite their own expertise, knowledge, and approach as more effective. 
We believe that it is important to encourage approaches to collaboration that effectively 
involve all the parties involved in requesting consent for donation. 
HRSA should develop an award that recognizes hospitals that demonstrate 
exemplary performance in organ donation. 
HRSA could work with HCFA and other agencies within the Department to develop 
criteria for this award.  Such an award would serve as a positive incentive to hospitals to 
enhance their commitment and efforts in encouraging organ donation.  It could be based 
on the data submission we describe above, as well as other efforts, such as community 
education programs.  We suggest that it may be appropriate for HRSA to issue the award 
during National Organ and Tissue Donor Awareness Week. 
24 
Organ Donation Rule  OEI-01-99-00020  C O M M E N T S  O N  T H E  D R A F T  R E P O R T  
Within the Department, the Health Care Financing Administration (HCFA) and the Health 
Resources and Services Administration (HRSA) provided written comments to our draft 
report.  We also received verbal comments from the Office of the Assistant Secretary for 
Planning and Evaluation. 
We solicited comments on the draft report from the Association of Organ Procurement 
Organizations (AOPO) and the American Hospital Association (AHA).  Here, we present 
a synopsis of the written comments from each agency and association, and, in italics, our 
response.  We also made some editorial and technical changes in the report, based on 
these comments.  Appendix B contains the full text of all written comments. 
Health Care Financing Administration 
HCFA responded positively to our report and recommendations.  The agency intends to 
explore ways in which additional data can be used to assess OPO effectiveness and 
hospital compliance with the donation rule.  HCFA comments that our recommendation 
about making organ donation data publicly available should be considered, taking into 
account the potential for misinterpretation of these data. 
We support HCFAs initiative to use data to assess OPO accountability.  In response to 
HCFAs concerns about public release of hospital-specific data on organ donation, we 
encourage the agency to review the experience of LifeGift, the Houston-based OPO, 
which has made such data publicly available in its annual report.  The OPO has reported 
no adverse consequences from that effort. 
We appreciate the additional information that the agency provided about the work 
underway to estimate organ donation potential by OPO service area. 
Health Resources and Services Administration 
HRSA responded positively to our report.  The agency concurred in our recommendations 
to it.  HRSA asks if the report could highlight examples of effective collaborative practices 
between OPOs and hospitals. 
We opted not to highlight any particular practices that we observed.  Although we did 
find examples where things appeared to be working well, a full assessment of such 
practices is beyond the scope of this inquiry.  We applaud HRSAs ongoing efforts to 
identify and publicize effective practices, such as the two technical assistance workshops 
that the agency has led on The Challenge of Collaboration.  These workshops have 
included presentations by OPO and hospital staff on successes and efforts to implement 
- 25 -
Organ Donation Rule  OEI-01-99-00020  the donation rule. 
HRSA asks if unique circumstances surrounded the large increase in donation at the OPO 
in Eastern Pennsylvania after that State enacted its required referral legislation. 
Undoubtedly, there were some unique circumstances.  We did not, however, conduct an 
independent analysis of that OPOs performance, or the reasons underlying that success. 
HRSA recommends that we recommend to HCFA that it require hospitals to submit data 
on referrals and organ recovery directly to HCFA. 
We considered having hospitals, not OPOs, report these data directly to HCFA and the 
OPTN, but rejected that idea for two reasons.  First, OPOs already collect these data in 
their ongoing collaboration and death record review in hospitals.  Second, our suggested 
approach minimizes the reporting burden on hospitals.  It seems much simpler to have 
the 59 OPOs (as of August, 2000) provide these data to HCFA and the OPTN, rather 
than to require each of 5,000 hospitals to submit the data. 
Association of Organ Procurement Agencies 
Overall, AOPO disagrees with many of our findings and recommendations.  The 
association raises a number of points, but places particular emphasis on our findings and 
discussion about limited training and use of designated requestors. 
AOPOs General Comments: 
<	 AOPO states that an underlying presumption of our report is that full compliance with the 
donation rule will lead to an substantial and immediate increase in organ donation.  The 
association notes that trends in donation are also affected by attitudes of the public and 
health professionals, as well as by causes and rates of death. 
We do not claim that the donation rule is, by itself, the answer to the shortage of 
organs.  However, the donation rule clearly gives OPOs the opportunity to be notified 
about more potential organ donors.  And, as we heard consistently from OPO staff, the 
rule gives OPOs greater clout and influence with hospitals to address donation.  Our 
report cites evidence of the progress that has been made. 
Despite this progress, almost half of the OPOs had fewer donors in 1999 than in 1998; in 
almost one-third of OPOs this decrease was greater than 10 percent.  By any measure, a 
national increase of less than one percent in organ donation must be considered a 
disappointment. 
<  AOPO supports our view that both OPOs and hospitals are accountable for organ 
- 26 -
Organ Donation Rule  OEI-01-99-00020  donation.  However, the association notes that effective collaboration must extend beyond 
merely meeting the requirements of the donation rule. 
We agree.  We recommend hospital-specific data submissions to HCFA as one way of 
increasing hospital accountability for organ donation.  We also recommend that HRSA 
develop an award recognizing hospitals that show exemplary performance in organ 
donation.  Both recommendations encourage joint ownership of organ procurement.  As 
AOPO notes, our report focused solely on implementing the donation rule, not on 
additional activities that OPOs perform in their ongoing interactions with hospitals. 
<	 AOPO recommends that we review important, recent empirical work by Siminoff, et al., 
on organ donation.  According to AOPO, this research found that consent for donation 
was highest when the request was made by an OPO coordinator. 
We appreciate AOPOs pointing out this important research on organ donation.  Data 
from the second study (completed in December 1999) have not yet been published, but we 
obtained copies of the final report on both studies submitted to the Agency for 
Healthcare Research and Quality, and we have reviewed that research carefully. 
We disagree with AOPOs characterization of the findings from that research.  The 
research does indicate that families who raised the issue of donation were more likely to 
donate, and it notes the importance of OPO staff spending time with families.  On the 
central point that AOPO raises, however, the investigators report, Donor rates were 
equivalent when doctors, nurses, social workers, or OPO staff raised the issue. 
<	 AOPO claims that the report did not fully develop the role physicians play in the donation 
process.  The association asks for further recommendations directed at physicians and the 
medical community. 
We address the role that physicians play and their concerns about the donation rule at 
two distinct places.  No one concerned about donation would disagree that additional 
steps could be taken to educate physicians and other health care professionals about 
organ donation.  We urge AOPO to play a leadership role in developing approaches to 
working with medical and specialty groups to address these issues. 
<	 AOPO believes that the Department of Health and Human Services, not individual OPOs, 
should have responsibility for any public reporting of hospital-specific compliance and 
other data about organ donation and recovery. 
We believe that OPOs should take on this responsibility for two reasons.  First, OPOs are 
the local resource providing information to the public about organ donation.  We view 
providing these data to the local area as part of that resource role.  Second, as we note in 
our response to HCFAs comments, the experience from at least one OPO indicates no 
- 27 -
Organ Donation Rule  OEI-01-99-00020  adverse consequences from that effort. 
<	 AOPO states that there is some evidence to suggest that hospital staff may be taking 
advantage of designated requestors to exclude OPOs from the donation process. 
We base our finding about designated requestors on survey data from both OPO 
directors and hospital staff.  We believe that this provides balanced evidence on this 
question.  We have added language in the report, based on our survey of hospitals.  We 
found that about 70 percent of hospitals had been offered designated requestor training 
by the OPO, but that staff in only 44 percent of hospitals had, in fact, been trained. 
<	 AOPO commented that the report did not include an assessment of the workload impact 
of the donation rule on OPOs, hospitals, and tissue banks. 
We examined that issue to a limited degree but did not report the data because it did not 
appear to impact implementation adversely.  While 65 percent cited an increase in the 
number of deaths referred to the OPO, only 2 percent responded that the amount of time 
it takes staff to notify the OPO about a patients death posed a major obstacle; and only 
2 percent responded that the amount of record keeping required was a major obstacle. 
<	 AOPO indicates that our report lends weight to conclusions of other research about the 
inadequacy of population-based performance measures. 
We did not assess the adequacy or inadequacy of population-based performance 
measures, but we are aware of the concerns that the OPO community has raised about 
such measures.  We believe, and we state in our recommendations, that the data we call 
for OPOs to submit to HCFA and to HRSA (through the OPTN) could be useful in 
shedding light on the population mix and causes of death among service areas. 
AOPOs Specific Comments: 
<	 AOPO claims that it is disingenuous to blame the donation rule for not achieving projected 
increases in organ donation, and it states that the projection is more of a challenge than a 
realistic projection. 
Nowhere do we blame the donation rule for not achieving the stated numerical goal.  The 
simple fact of the matter, however, is that the actual increase in donation fell far short of 
the increase that the Department projected when promulgating this regulation. 
<	 At several places the association disagrees with our findings and discussion about how 
OPOs resist using hospital staff to discuss donation. 
As we note above, we base these findings on surveys of and discussions with both the 
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Organ Donation Rule  OEI-01-99-00020  OPO and hospital communities.  We acknowledge the expertise and training of OPO 
staff, their interaction with families, and their ongoing involvement with and knowledge 
of donation.  However, at an organizational level, we found a number of practices that 
indicate OPO resistance to training and using hospital staff as designated requestors. 
<	 The association states that OPOs were required to assist hospitals in implementing the 
donation rule, but did not receive additional funding to do so. 
We recognize that OPOs did not receive additional funding to implement the donation 
rule.  However, an OPO would be able to recover the appropriate portion of those costs 
through its Medicare cost recovery process.  In addition, to the extent that an OPO 
increased organ procurement, it would realize revenue by placing additional organs. 
<	 AOPO cautions that a careful definition of the term imminent death is required for data 
collection statistics. 
We recognize that defining imminent death requires medical judgement, and that such 
a definition may differ among physicians, OPOs, and hospitals.  We are not proposing 
that a national definition of imminent death be developed.  We would expect an OPO to 
submit data to HCFA in accordance with the criteria and definition that the OPO uses. 
American Hospital Association 
<	 Overall, AHA raises concerns about our recommendations related to increased reporting 
of hospital-specific data on donation.  The association believes that the full freight of 
increasing organ donation nationwide cannot and should not rest on a regulatory 
solution. 
Our recommendations proceed from the underlying assumption that data measurement 
forms the basis for performance improvement.  In our efforts to determine the extent to 
which hospitals are complying with this Medicare condition of participation, and the 
extent to which organ donation has changed in response to it, it was readily apparent to 
us that timely data are not available on a voluntary basis.  It is for this reason that we 
recommend that HCFA require the submission of such data. 
<	 The association stresses the importance of maintaining collaborative relationships between 
hospitals and OPOs. 
We agree with the importance of collaborative relationships and cite a number of areas 
in which they are working well.  But we also found areas in which improvements could be 
made.  These areas include expanding the availability of designated requestor training 
for hospital staff and improving cumbersome operational procedures within hospitals. 
We hope that AHA will establish its own initiatives to deal with these shortcomings. 
- 29 -
Organ Donation Rule  OEI-01-99-00020  <	 AHA expresses concern about our recommendation that OPOs provide hospital-specific 
data to the Department on referrals and on organ recovery. 
As we note in our response to HRSAs comments, OPOs already collect these data.  We 
also felt strongly that our suggested approach would minimize the reporting and 
regulatory burden on hospitals.  It seems much simpler (and, indeed, more amenable to 
the hospital community) to have the 59 OPOs provide these data to the Department, 
rather than to require each of 5,000 hospitals to submit the data. 
<	 AHA notes that our report does not address the OPOs infrastructure capacity to deal 
with the requirements of the donation rule. 
As we note in our response to AOPO, we examined that issue to a limited degree but did 
not report the data because it did not appear to impact implementation adversely. 
<	 AHA raises concerns that our recommendations would place OPOs in the position of 
ensuring compliance with a hospital condition of participation. 
Our recommendations do not call on the OPOs to perform a compliance function. 
Compliance monitoring would continue to be the responsibility of HCFA, the State 
surveyors, and the Joint Commission.  Our recommendation would merely have the 
OPOs transmit data that they already collect to HCFA.  HCFA could then use those data 
to assess if and where hospitals are not meeting their obligations. 
<	 AHA disagrees with our recommendations that OPOs should make hospital-specific data 
on donation public.  The Association raises concerns that the public might misconstrue 
these data and the performance of a particular hospital in this regard. 
As we note in our response to HCFAs comments, the experience from at least one OPO 
indicates no adverse consequences from that effort. 
<	 AHA agrees with our recommendation that HRSA support demonstration projects on 
training and using designated requestors.  AHA urges the Department to establish projects 
to further the research on successful models of securing consent and encouraging 
donation. 
We welcome the AHAs support of this recommendation.  We believe that there are many 
opportunities to review and publicize effective practices on donation. 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX A 
Methodology

Data Collection from Organ Procurement Organizations 
We mailed a survey to the executive directors of the 61 organ procurement organizations 
in October 1999, with a follow-up mailing to those that had not responded in November. 
We received responses from all 61 OPOs in operation at that time.  Since then, two OPOs 
no longer operate, and their service areas have been subsumed by other OPOs.  We use 
61 OPOs in reporting our results because that was the number operating at the time of the 
survey. 
Data Collection from Hospitals 
We mailed a survey to the chief executive officer of a stratified random sample of 
Medicare-certified hospitals in February 2000, with a follow-up mailing to those that had 
not responded in March. 
Our original sample comprised 450 hospitals, selected using HCFAs OSCAR database. 
We stratified the universe into three groups, based on number of certified beds:  hospitals 
with 100 or fewer beds, hospitals with 101 to 299 beds, and hospitals with 300 or more 
beds.  When compared with the national distribution of Medicare hospitals, this strategy 
undersamples the smallest hospitals and oversamples the largest hospitals.  We chose this 
sampling scheme because larger hospitals are more likely to see potential organ donors 
than are smaller hospitals.  Because the donation rule applies to all Medicare-certified 
hospitals, we wanted to have adequate representation among all 3 categories of hospitals. 
Therefore, in presenting estimates from our hospital survey, we have weighted the 
responses to reflect their proportions in the national population.  On the following pages, 
we present the confidence intervals for the variables used in this report, and a non-
respondent analysis. We found no difference between the sample and the population on 
two key variables: type of hospital and hospital control. 
We deleted 3 hospitals from the original sample after internal consultations with other 
components of the Office of Inspector General, reducing our sample size to 447. We then 
found that another 8 hospitals had ceased operation, even though they still appeared in the 
OSCAR database, reducing our sample size to 439.  We then found that 5 hospitals were 
critical access hospitals, for which the Medicare conditions of participation do not apply 
and which, therefore, were not subject to the donation rule.  This reduced our final sample 
size to 434 hospitals. 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX A 
We received responses from 357 hospitals, yielding a response rate of 79 percent of the 
total sample.  Deleting the responses from the 4 critical access hospitals yielded a total of 
353 responses, or 81 percent of the reduced sample of 434 hospitals. 
Characteristics of Hospital Sample 
Certified  Population  Sample  Number of  Response 
Beds  Size  Responses  Rate 
< =100  3,236  150  117  78.0 % 
101-299  1,882  150  125  83.3 % 
>= 300  1,010  150  111  74.0 % 
TOTALS  6,128  450  353  78.4 % 
Non-Respondent Analysis 
Item:  Respondent  Non-
Total  Percent 
Hospital Type  s  Respondents 
General Hospitals  303  (85.8 %)  77  (79.4 %)  380  79.7 % 
Other Hospitals  50 (14.2 %)  20  (20.6 %)  70  71.4 % 
Total  353  97  450  78.4 % 
Chi - square statistic = 0.5201  Degrees of freedom = 1 
Item:  Non-
Respondents  Total  Percent 
Hospital Control  Respondents 
Voluntary non-profit  190  (53.8 %)  55  (56.7 %)  245  77.6 % 
Proprietary  65  (18.4 %)  17  (17.5 %)  82  79.3 % 
Public  98  (27.8 %)  25 (25.8 %)  123  79.7 % 
Total  353  97  450  78.4 % 
Chi - square statistic = 0.0558  Degrees of freedom = 2 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX A 
Confidence intervals for key questions 
95 % Confidence 
Raw Value  Weighted 
Description  Interval for Weighted 
(%)  Estimate  (%) 
Value 
Hospital had voluntary 
54.5 %  51.3 %  +/- 5.8 % 
arrangement to report deaths 
Increase in deaths referred to 
66. 9%  64.7  +/- 5.6 % 
OPO 
Increase in imminent deaths 
45.2 %  39.8 %  +/- 5.4 % 
referred to OPO 
Time needed to notify OPO about 
2.6 %  1.9 %  +/- 1.3 % 
a patients death 
Responsiveness of OPO to phone 
3.2 %  2.3 %  +/- 1.5 % 
calls 
OPO offered to train hospital staff 
72.3 %  70.3 %  +/- 5.4 % 
as designated requestor 
Hospital staff trained as 
44.3 %  43.7 %  +/- 5.7 % 
designated requestor by OPO 
Increase in hospitals overall 
66.4 %  65.3 %  +/- 5.5 % 
interaction with OPO 
Increase in presence of OPO staff 
40.7 %  35.6 %  +/- 5.2 % 
in hospital 
Increase in responsiveness of 
49.1 %  47.1 %  +/- 5.8 % 
OPO to hospitals concerns 
Increase in referral of donors -
28.1 %    +/- 8.2% 
hospitals <= 100 beds 
Increase in referral of donors -
50.8 %    +/- 9.2% 
hospitals 101-299 beds 
Increase in referral of donors -
56.8 %    +/- 9.2% 
hospitals > = 300  beds 
- 33 -
Organ Donation Rule  OEI-01-99-00020  APPENDIX A 
Site Visits 
We conducted site visits to the service areas of two OPOs: Southern California Organ 
Procurement Center (Los Angeles) and Southwest Transplant Alliance (Dallas).  During 
our visits we interviewed staff from the OPO; hospital personnel, including nurses, social 
workers, administrators, and clergy; hospital-based physicians; and tissue bank staff. 
Interviews with OPO Staff and External Stakeholders 
We interviewed, either in person or by telephone, staff from eight additional OPOs.  We 
also interviewed staff from the Association of Organ Procurement Organizations, the 
American Hospital Association, the American Association of Tissue Banks, and the Eye 
Bank Association of America. 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
Comments on the Draft Report 
In this appendix we present the full text of comments of the parties that responded to our 
draft report.  We present them in the following order: 
C  Health Care Financing Administration 
C  Health Resources and Services Administration 
C  Association of Organ Procurement Organizations 
C  American Hospital Association 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX B 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX C 
Endnotes

1. HHS Fact Sheet, National Organ and Tissue Donation Initiative, April 16, 1999.  In 1998, 
organ donation increased 5.7 percent, the first substantial increase since 1995.  Data on size of the 
waiting list are updated through August 6, 2000, using data from the United Network for Organ 
Sharing, at http://www.unos.org. 
2. HHS Fact Sheet, National Organ and Tissue Donation Initiative, April 16, 1999. 
3. By May, 2000, this number had decreased to 59 OPOs, as service areas were merged.  We 
conducted our survey at the end of 1999, and use 61 as the number of OPOs in this report. 
4.  To be recertified, OPOs must meet at least 75 percent of the national mean on four of the 
following five standards, measured per million population, in their service area: 
C  organ donors 
C  kidneys procured 
C  kidneys transplanted 
C  extra renal organ procured 
C  extra renal organs transplanted. 
The Balanced Budget Act of 1997 authorizes the Secretary to expand the certification period 
for an OPO to four years if appropriate on the basis of its past practices (P.L. 105-63, Sec. 4642). 
5. HCFA recognized that full implementation of this rule could take up to a year, although it 
expected hospitals to make progress toward implementation during the phase-in period. 
6.  42 C.F.R., sec. 283.45 was added at 63 Fed. Reg.  33,875, June 22, 1998, effective August 21, 
1998.  The full regulation reads as follows: 
 482.45  Conditions of participation: Organ, tissue, and eye procurement 
(a) Standard: Organ procurement responsibilities.  The hospital must have and 
implement written protocols that: 
(1) Incorporate an agreement with an OPO designated under part 486 of this 
chapter, under which it must notify, in a timely manner, the OPO or a third party 
designated by the OPO of individuals whose death is imminent or who have died in the 
hospital.  The OPO determines medical suitability for organ donation and, in the absence 
of alternative arrangements by the hospital, the OPO determines medical suitability for 
tissue and eye donation, using the definition of potential tissue and eye donor and the 
notification protocol developed in consultation with the tissue and eye banks identified by 
the hospital for this purpose; 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX C 
(2) Incorporate an agreement with at least one tissue bank and at least one eye 
bank to cooperate in the retrieval, processing, preservation, storage, and distribution of 
tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are 
obtained from potential donors, insofar as such an agreement does not interfere with organ 
procurement; 
(3) Ensure, in collaboration with the designated OPO, that the family of each 
potential donor is informed of its options to donate organs, tissues, or eyes or to decline to 
donate.  The individual designated by the hospital to initiate the request to the family must 
be an organ procurement representative or a designated requestor.  A designated 
requestor is an individual who has completed a course offered or approved by the OPO 
and designed in conjunction with the tissue and eye bank community in the methodology 
for approaching potential donor families and requesting organ or tissue donation; 
(4) Encourage discretion and sensitivity with respect to the circumstances, views, 
and beliefs of the families of potential donors; 
( 5) Ensure that the hospital works cooperatively with the designated OPO, tissue 
bank and eye bank in educating the staff on issues, reviewing death records to improve 
identification of potential donors, and maintaining potential donors while testing and 
placement of potential donated organs, tissues, and eyes take place. 
7.  William DeJong et al., Requesting Organ Donation: An Interview Study of Donor and 
Nondonor Families, American Journal of Critical Care 7 (January 1998) 1: 13-23; Michael J. 
Evanisko et al., Readiness of Critical Care Physicians and Nurses to Handle Requests for Organ 
Donation,  American Journal of Critical Care 7 (January 1998) 1: 4-12; Patrick McNamara and 
Carol Beasley, Determinants of Familial Consent to Organ Donation in the Hospital Setting, 
Clinical Transplants 1997, Cecka and Terasakai, Eds., (UCLA Tissue Typing Laboratory, 1998), 
219-229. 
8.  Confidence intervals for all estimates appear in Appendix A. 
9.  To be recertified, OPOs must meet at least 75 percent of the national mean on four of the 
following five standards, measured per million population, in their service area: 
OPO Performance Standards: 
Average per year for 1999 and 1998 
Measure  Mean*  Range* 
Donors per million population  21.5  13.4 - 38.0 
Kidneys procured per million  39.3  25.0 - 69.4 
Kidneys transplanted  per million  34.0  22.3 - 61.9 
Extra renal organs procured per million  38.0  19.0 - 70.7 
Extra renal organs transplanted per million  34.4  15.2 - 67.7 
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Organ Donation Rule  OEI-01-99-00020  APPENDIX C 
* The Puerto Rico OPO is included in the mean, but excluded from the range presented here 
10.  42 C.F.R., sec. 482.45 (a) (3) 
11.  Office of Inspector General, The External Review of Hospital Quality: A Call for Greater 
Accountability (OEI-01-97-00050), July 1999, p. 16. 
12.  LifeGift, the Houston-based OPO, provides hospital by hospital performance data in its 
annual report. 
13.  The State surveyors survey only hospitals.  The OPO surveys are conducted by HCFA 
regional office staff. 
14.  Hospitals that receive Joint Commission accreditation are deemed to meet the Medicare 
conditions of participation. 
15.  Office of Inspector General, The External Review of Hospital Quality: The Role of Medicare 
Certification (OEI-01-97-00052), July 1999, p. 10. 
14.  For Joint Commission standards that relate to patient care or outcomes of care, hospitals 
may receive a rating that ranges from 1 to 5, with 1 being substantial compliance and 5 
noncompliance.  In assessing a provision such as a hospitals compliance with the donation rule, 
the worst score possible is a 2, which stands for significant compliance. 
17.  Fed. Reg. 33,871 June 22, 1998. 
18.  The rule was effective August 21, 1998.  The data reported here compare calendar years 
1998 and 1999.  These data are reported to HCFA for the OPO certification process. 
19.  In responses to our survey, OPOs indicated that the following States have laws that require 
hospital to notify their OPO of all deaths.  We have not done an independent legal review to 
confirm these laws, or their specific provisions and limitations:  Arizona, Delaware, Florida, 
Hawaii, Maryland, Michigan, Mississippi, New Jersey, New York, North Carolina, Ohio, 
Pennsylvania, Tennessee, Texas, Virginia, Wisconsin. 
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Organ Donation Rule  OEI-01-99-00020