Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

JUNE GIBBS BROWN 

Inspector General 

AUGUST 2000 

OEI-01-99-00020 

Medicare Conditions of Participation for 

Organ Donation: 

An Early Assessment of the New Donation Rule 
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 

Russell W. Hereford, Ph.D., Project Leader 

Maria E. Maddaloni, M.A., Program Analyst 

HEADQUARTERS 

Alan Levine, Program Specialist

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 
EXECUTIVE SUMMARY 

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. 

Organ Donation Rule 1 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 

Organ Donation Rule 2 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 rule’s 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. 

Organ Donation Rule 3 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 

Organ Donation Rule 4 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. 

Organ Donation Rule 5 OEI-01-99-00020 
TABLE OF CONTENTS 

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

Organ Donation Rule 6 OEI-01-99-00020 
INTRODUCTION 

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 Department’s 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). HRSA’s 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 

Organ Donation Rule 7 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 OPO’s 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. 

Organ Donation Rule 8 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 individual’s 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 relative’s 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. 

Organ Donation Rule 9 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 President’s Council on Integrity and Efficiency. 

Organ Donation Rule 10 OEI-01-99-00020 
Organ Donation Rule 11 OEI-01-99-00020

PRIMER ON ORGAN DONATION 

The Process of Donation 

1. 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. 

maintained for up to several days on a ventilator, a machine that provides artificial life support for 

breathing and respiratory function. 

2. The hospital notifies its OPO about the 

individual who has died or whose death is imminent. 

preliminary assessment of that individual’s medical suitability as an organ donor. 

3. . 

and maintain vascular organ function through medical treatment. 

4. . 

is brain dead. 

irreversible loss of all brain function. 

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. A trained OPO staff member or a hospital’s designated requestor asks the 

individual’s family members for consent to donate their relative’s organs. 

indicated willingness to donate organs (e.g., on the driver’s license), it is practice in this country to obtain 

consent from the next-of-kin. 

all or only some organs. 

6. If the family consents to donation, the organs are removed in an operating room 

in a sterile surgical procedure. 

7. 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 generally includes a severely brain-injured individual on a ventilator. 

Designated Requestor. 

approved by the OPO in the methodology for approaching potential donor families and requesting organ 

donation. 

Identifying a Potential Organ Donor.

Upon admission to a hospital, the individual may be 

Notifying the Organ Procurement Organization (OPO). 

OPO staff obtain information needed for a 

Managing the Donor’s Care Medical, hospital, and OPO personnel monitor the individual’s progress 

Determining and Declaring Brain Death Physicians conduct tests to determine whether the individual 

If brain death is confirmed, a physician declares death. Brain death is the complete and 

Brain death can be determined through tests that include an 

Requesting Consent. 

Even if the individual had 

A family may refuse to give consent, or it may give consent for donation of 

Recovering Organs. 

Transporting Organs for Transplantation.

Imminent death is defined under hospital policies devised in conjunction with its OPO. 

A designated requestor is an individual who has completed a course offered or 
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. 

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 hospital’s involvement in donation depended to 

a large extent on the persuasiveness of OPO staff and the comitment of key clinicians and 

Organ Donation Rule 12 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 hospital’s 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 hospital’s 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. 

Organ Donation Rule 13 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-fitsall 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 

Organ Donation Rule 14 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 family’s 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 hasn’t 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 OPO’s job,” one in which the hospital staff should have 

no involvement, there is likely to be little true collaboration or interest in organ donation. 

Organ Donation Rule 15 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.” 

Organ Donation Rule 16 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 

hospital’s 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 HCFA’s job — not the OPOs’ — to enforce any 

noncompliance by hospitals. 

However, the OPOs do not facilitate HCFA’s ability to ensure compliance with the rule’s 

provisions. Only two OPOs indicated that they would inform HCFA about poor 

compliance by hospitals with the rule’s 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. 

Organ Donation Rule 17 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 rule’s impact on organ donation. 

OPOs gather data that could be used to help determine the rule’s 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 

Organ Donation Rule 18 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 HCFA’s 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. 

Organ Donation Rule 19 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). 

Organ Donation Rule 20 OEI-01-99-00020 
<

RECOMMENDATIONS 

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. 

HCFA’s 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 rule’s potential. In particular, we 

found problems in the rule’s 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 rule’s effect on donation and that 

Organ Donation Rule 21 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 

Organ Donation Rule 22 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 

Organ Donation Rule 23 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. 

Organ Donation Rule 24 OEI-01-99-00020 
COMMENTS ON THE DRAFT REPORT 

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 HCFA’s initiative to use data to assess OPO accountability. In response to 

HCFA’s 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 HRSA’s 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 

Organ Donation Rule - 25 - 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 OPO’s 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. 

AOPO’s 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 

Organ Donation Rule - 26 - 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 AOPO’s 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 AOPO’s 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 HCFA’s comments, the experience from at least one OPO indicates no 

Organ Donation Rule - 27 - 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 patient’s 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. 

AOPO’s 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 

Organ Donation Rule - 28 - 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. 

Organ Donation Rule - 29 - 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 HRSA’s 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 HCFA’s 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 AHA’s support of this recommendation. We believe that there are many 

opportunities to review and publicize effective practices on donation. 

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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 HCFA’s 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 nonrespondent 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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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 

Beds 

Population Sample 

Size 

Number of 

Responses 

Response 

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: 

Hospital Type 

Respondent 

s 

NonRespondents Total Percent 

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: 

Hospital Control Respondents NonRespondents Total Percent 

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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APPENDIX A 

Confidence intervals for key questions 

Description Raw Value 

(%) 

Weighted 

Estimate (%) Interval for Weighted 

95 % Confidence 

Value 

Hospital had voluntary 

arrangement to report deaths 54.5 % 51.3 % +/- 5.8 % 

Increase in deaths referred to 

OPO 66. 9% 64.7 +/- 5.6 % 

Increase in imminent deaths 

referred to OPO 45.2 % 39.8 % +/- 5.4 % 

Time needed to notify OPO about 

a patient’s death 2.6 % 1.9 % +/- 1.3 % 

Responsiveness of OPO to phone 

calls 3.2 % 2.3 % +/- 1.5 % 

OPO offered to train hospital staff 

as designated requestor 72.3 % 70.3 % +/- 5.4 % 

Hospital staff trained as 

designated requestor by OPO 44.3 % 43.7 % +/- 5.7 % 

Increase in hospital’s overall 

interaction with OPO 66.4 % 65.3 % +/- 5.5 % 

Increase in presence of OPO staff 

in hospital 40.7 % 35.6 % +/- 5.2 % 

Increase in responsiveness of 

OPO to hospital’s concerns 49.1 % 47.1 % +/- 5.8 % 

Increase in referral of donors -

hospitals <= 100 beds 28.1 % — +/- 8.2% 

Increase in referral of donors -

hospitals 101-299 beds 50.8 % — +/- 9.2% 

Increase in referral of donors -

hospitals > = 300 beds 56.8 % — +/- 9.2% 

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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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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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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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APPENDIX B 

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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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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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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 hospital’s 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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