Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

ORGAN PROCUREMENT ORGANIZATIONS


AND TISSUE RECOVERY


.ab~SERVICE$ 

“b. 

+Q’ >1 

,J’ ~ JUNE GIBBS BROWN 

nspector General 

L 

“~d3a> 2 MAY 1994 

0EI-01-91-O0250 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services’ (HHS) 

programs as well as the health and welfare of beneficiaries served by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Office of Audit Services, the 

Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs 

the Secretary of HHS of program and management problems and recommends courses to 

correct them. 

OFFICE OF AUDIT SERVICES 

The OIG’S Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS programs and/or its grantees and contractors in 

carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS 

The OIGS Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of 

unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions, 

administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 

control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 

OFFICE OF EVALUATION AND INSPECTIONS 

The OIG’S Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and recommendations contained in these inspection 

reports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability, 

and effectiveness of departmental programs. 

This report was prepared under the direction of Mark R. Yessian, Ph.D., Regional Inspector 

General, and Martha B. Kvaal, Deputy Regional Inspector General, Boston Region, Office of 

Evaluation and Inspections. Participating in this project were the following people: 

Boston Headquarters 

Russell W. Hereford, Ph. D., Project Leader Mary Beth Clarke 

Joyce M. Greenleaf 

For additionalcopiesof thisrepq please contactthe Boston regionalojjice 

by telephoneat (617) 565-1050, or by fm at (617) 565-3751. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

ORGAN PROCUREMENT ORGANIZATIONS


AND TISSUE RECOVERY


@ SERVICE$ 

~d+ ~$~ 

Z* JUNE GIBBS BROWN 

2.

s Inspector General 

‘6 

%. $

>+‘%d~~ 2 MAY 1994

OEI-01-91-00250 
EXECUTIVE SUMMARY


PURPOSE 

To describe and assess the role of organ procurement organizations in procuring tissue 

for transplantation, and to identify vulnerabilities associated with that involvement. 

BACKGROUND 

Human tissue grafts, from perhaps 10,000 donors, benefit as many as a half-million 

people annually. The great majority of these transplanted tissues are bones, bone 

products, or other parts of the musculo-skeletal system, such as tendons, fascia, and 

soft tissues. Consequently, we focus this inspection report on bone and musculoskeletal tissue, and we use the term “tissue” to refer to these. 

In December 1993, the Food and Drug Administration (FDA) regulated tissue 

banking for the first time by requiring testing for infectious disease, donor screening, 

and record keeping. New York, Florida, and California now regulate tissue banking at 

the State level. 

Organ procurement organizations (OPOS) are responsible for recovering organs from 

donors. The National Organ Transplant Act requires that OPOS must also “have 

arrangements to cooperate with tissue banks for the retrieval, processing, preservation, 

storage, and distribution of tissues as may be appropriate to assure that all useable 

tissues are obtained from potential donors.” While OPOS see organ procurement as 

their primary function, to the extent that statutory expectations for tissue recovery are 

not met, opportunities for donating and using tissues are lost. 

This inspection report focuses on the supply of tissues and the role of the OPOS in 

procuring tissue. The Public Health Semite (PHS) estimates that 125 bone banks in 

the United States recover, process, and/or distribute bone for transplantation. 

Federal law requires that OPOS have arrangements with tissue banks for tissue 

procurement. How well they perform this role can have a significant bearing on 

recovering a sufficient supply of high quality tissue for transplantation. The OPOS 

already are involved in tissue banking by virtue of their involvement in organ 

procurement. As much as 60 percent of bone tissue used for transplantation comes 

from donors of solid organs. 

We conducted a mail survey of all Medicare-certified OPOS, with a response rate of 

95 percent; interviewed staff from 15 OPOS by telephone; made site visits to four 

OPOS, as well as tissue banks and hospitals in their service areas; interviewed Federal 

officials from PHS and the Health Care Financing Administration (HCFA) and staff 

from relevant associations; conducted a focus group with directors of five tissue banks; 

and reviewed pertinent Federal reports, legislation, and literature. 

i 
FINDINGS 

AU 62 OPOS responding to our survey participate in tiwue recovery to some degree. 

. Thirty-four OPOS refer potential donors to tissue banks. 

� Twenty-eight OPOS recover tissue themselves. 

7he OPOS’ commitment to tiwue recoveiy varies widely. Performance data show that they have 

not taken fid advantage of opportunitz”e.sto obtain tiwue from potential donom 

As part of our review, we developed three performance indicators to measure the 

OPOs’ involvement in tissue recovery: 

Organ Donors Referred to Tissue Banks: For the 34 OPOS that refer potential tissue 

donors to tissue banks, we measured the percentage of organ donors who were 

referred for tissue donation. This performance indicator assesses the degree to which 

an OPO actually refers its organ donors for tissue donation. 

� Three of these OPOS reported that they referred all of their organ donors for 

tissue recove~. At the other extreme, 2 OPOS reported that they referred fewer 

tilan 20 percent of oqan donors for hksue donation. 

Organ Donors Providing Tissues: For the 28 OPOS that recover tissue, we measured 

the percentage of organ donors from whom they recovered both organs and tissues. 

This performance indicator assesses the emphasis that an OPO gives to organ donors 

as a source of tissue. 

1 

* The percentage of otgan donors from whom these OPOS recovered both organs 

and tzkue ranged from a high of 43 percent to a 10w of 6 percent. 

Ratio of Tissue Donors to Organ Donors: For the 28 OPOS that recover tissue, we 

measured the ratio of tissue donors to organ donors. This performance indicator 

assesses the attention that an OPO ~laces on nonor~an donors as a source of tissue. 

e Three of these OPC)S reported more than 150 tissue donors for eve~ 100 o?gcm 

donors. At the other extreme, 3 OPOS procured tissue from fewer than 20 tissue 

donom for evety 100 organ donors. 

ii 

I 
Tem”ons &t between o~an procurement and tiwue recovery. If these tem”ons intemijj, thty 

could have adveme consequences for lhe supply of tkw.us and of organs. 

�	 Inherent differences between organ procurement and tissue recovexy (in 

urgency, prestige, and organization) can limit OPOS’ and tissue banks’ 

willingness to work together. 

�	 Competition for donors among multiple tissue banks could threaten hospitals’ 

eagerness to work with OPOS and tissue banks. 

Some OPOS and tissue bankx have developed ejfective practices to improve ogan and tkrue 

donation. 

�	 Some OPOS and tissue banks are working together to facilitate communication 

and cooperation. These efforts include a central telephone system to receive 

all donor referrals and m“tten agreements specifying referral arrangements 

among OPOS and tissue banks. 

�	 Some OPOS have established programs under which hospitals routinely refer all 

deaths to the OPO to increase the number of donor referrals. 

RECOMMENDATIONS 

Our recommendations arise from the statutory requirement that OPOS “have 

arrangements to cooperate with tissue banks for the retrieval of tissues to assure that 

all useable tissues are obtained from potential donors.” Little national attention has 

focused on this mandate. The relationship between tissue banks and organ 

procurement organizations can have a significant impact on overall OPO performance. 

The PHS should provtie some general oversight and guidance for OPO.Yregarding the+ 

arrangement wdh tissue banks and their tissue recovery activity. 

We encourage PHS to collect routine data about OPO involvement with tissue 

recovery. The agency could also disseminate information about effective OPO tissue 

banking practices to improve donation. In addition, we urge PHS to keep a watchful 

eye on tensions between OPOS and tissue banking to determine if these tensions are 

jeopardizing the supply of tissues and organs. 

7?aeHCFA shouki include an assessment of OPOS’ peflormance in tiwue recove~ as part of 

the OPO recertification process. 

The HCFA could utilize performance indicators to assess how well OPOS are meeting 

the requirement that they have arrangements to cooperate with tissue banks. We 

recognize that recertification focuses on an OPO’S performance with respect to organ 

procurement and distribution. We believe that some measure of accountability for 

OPO performance in tissue recovery is also warranted. 

... 

111 
.. COMMENTS 

Within the Department of Health and Human Services, we received comments on the


draft report from PHS, HCFA, and the Assistant Secretary for Planning and


Evaluation (ASPE). We also received comments from the United Network for Organ


Sharing (UNOS), the American Association of Tissue Banks (AATB), and the


Association of Organ Procurement Organizations (AOPO). Overall, the comments


share three major points:


Adliitionai resoumes would be needed for PHS to provkie general overnightand guidance. 

The PHS concurs with our recommendation that the agency provide some general 

oversight and guidance for OPOS regarding their arrangements with tissue banks and 

their tissue recovery activity. That agency, AATB, and UNOS indicate, however, that 

additional resources would be needed to implement this recommendation, and ASPE 

calls it infeasible at this time. We are aware that funding for new initiatives is limited, 

but we believe that PHS could begin providing general oversight and guidance without 

incurring extensive new expenditures and without imposing a major reporting burden 

on agencies or tissue banks. Existing reporting systems can be revised incrementally to 

obtain these data with a minimum of expense and effort. We would be pleased to 

work with PHS toward this end. 

?he spec@c Peflormance indicatom we developed may not be adequate to evaluate OPOS’ 

peflorrnance in tiwue recovery. 

The AATB finds our performance indicators to be reliable indicators of the strength 

of OPO commitment to tissue recovery from cadaveric donors, but HCFA, ASPE, and 

AOPO question their adequacy. We developed these indicators from readily available 

data, but we are confident that other indicators also would show wide variation in 

OPO performance. We are not wedded to these or other particular performance 

indicators. Rather, we offer them as a starting point in deliberations to develop 

performance indicators for OPOS and tissue banking. We encourage FICFA and PHS 

to collaborate either to modify these indicators or to develop other indicators that will 

begin to hold OPOS accountable for their activities with regard to tissue recovery. 

Includihg an assessment of OPO performance in tiwue recovey as part of the Medicare 

recertification procms k not fem”ble at present. 

Both HCFA and ASPE identify regulatory barriers to including an assessment of OPO 

performance in tissue recovery as part of OPO Medicare recertification processes. 

The HCFA notes that such an effort is a long-term initiative, which must be preceded 

by data collection and development of appropriate and valid performance indicators. 

We believe that the long lead time that HCFA requires makes a compelling case for 

initiating this activity soon. Collecting necessary data and developing more refined 

performance indicators are a precondition for this assessment. Consequently, we urge 

HCFA to establish an appropriate schedule to carry out such a proposal. 

iv 
� 

� 

TABLE OF CONTENTS


PAGE 

EXECUTIVE SUMMARY 

INTRODUCI’ION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...1


FINDINGS 

�All OPOs participate in tissue recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...4


. The OPOS’ commitment to tissue recovery varies widely . . . . . . . . . . . . . . . . . . 6


. Tensions exist between organ procurement and tissue recovery . . . . . . . . . . . . 10


.	 Some OPOS and tissue banks have developed effective practices to improve tissue


and organ donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12


RECOMMENDATIONS


The PHS should provide some general oversight and guidance for OPOS regarding


their arrangemen~s with tissue banks and their tissue recovery practices . . . . . 14


The HCFA should include an assessment of OPOS’ performance in tissue recovery


aspartof the OPO recertification process . . . . . . . . . . . . . . . . . . . . . . . . . ...15


COMMENTS ON THE DRAIT REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . ...16


APPENDICES


A Overview of Tissue Recovery, Processing, and Distribution . . . . . . . . . . . . . . A-1


B: Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. B-1


CComments onthe Draft Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. C-l


D: Endnotes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. D-l

INTRODUCTION -


PURPOSE 

To describe and assess the role of organ procurement organizations in procuring tissue 

for transplantation, and to identi@ vulnerabilities associated with that involvement. 

BACKGROUND 

Human tissue grafts, from perhaps 10,000 donors, benefit as many as a half-million 

people annually. 1 The great majority of these transplanted tissues are bones, bone 

products, or other parts of the musculo-skeletal system, such as tendons, fascia, and 

soft tissues. Consequently, we are focusing this inspection on bone and musculoskeletal tissue, and we use the term “tissue” to refer to these. Tissues are used in 

procedures such as knee and hip replacements, spinal surgery, dental surgery, and 

strengthening ligaments and tendons.z 

The Organ tiocurement System 

Organ procurement organizations (OPOS) are responsible for recovering organs from 

donors. The nation’s 65 OPOS encourage organ donation, identify potential organ 

donors, obtain consent from next-of-kin, oversee the surgical excision of organs, 

coordinate the various laboratory tests associated with transplantation, arrange for 

transportation of organs, and operate a central register of transplant candidates in 

their service area.3 

The National Organ Transplant Act requires that OPOS must also “have arrangements 

to cooperate with tissue banks for the retrieval, processing, preservation, storage, and 

distribution of tissues as may be appropriate to assure that all useable tissues are 

obtained from potential donors.”4 However, neither the Federal government nor the 

federally funded Organ Procurement and Transplantation Network (OPTN) provides 

guidance about these arrangements. Undoubtedly, OPOS see organ procurement as 

their prima~ function. At the same time, however, the National Organ Transplant 

Act clearly envisions an important role for OPOS in facilitating the recovery of tissues. 

To the extent that this expectation is not met, opportunities for donating and using 

tissues are lost. 

An OPO also must have a working relationship with at least 75 percent of the 

Medicare hospitals in its service area. At the same time, Medicare participating 

hospitals must establish written protocols to identify potential organ donors. In most 

cases, these protocols utilize the OPO to carry out this function, giving them access to 

hospitals’ actual and potential organ donors. Consequently, this access to hospitals 

places OPOs in a strong position to coordinate recovery of tissues from these or other 

hospital-based donors. 

1

lZe llisue Banking lhdusl~ 

The Public Health Service (PHS) estimates that 125 bone banks operate in the United 

States, in addition to a number of small hospital facilities that retrieve and store bone 

from living donors. The American Association of Tissue Banks (AATB), a national 

professional organization, has accredited 50 tissue banks of all types that meet its 

voluntary standards, including bone banks.s 

Tissue banking has three stages: (1) Recovery or procurement, the stage at which 

donors are identified and screened, consent is obtained from next-of-kin, and the bone 

is surgically recovered from a donor; (2) Processing and preservation, in which the 

bone is cleaned, treated, and preserved for future use; and (3) Distribution, in which 

the presexved bone is distributed to hospitals, surgeons, and dentists for implantation. 

(Appendix A provides a more detailed description of each of these stages.) 

This report focuses on the procurement stage, during which tissue is recovered. This 

stage is the point at which the supply is established and is likely to be the most direct 

focus of OPO involvement. 

Federal Interest in llssue Procurement 

In December 1993, the Food and Drug Administration (FDA) regulated tissue 

banking for the first time. The FDA issued an interim rule to require testing for 

certain infectious disease, donor screening, and record keeping in response to concerns 

that some human tissues were being offered for transplantation use without even 

minimum donor testing and screening.b 

This report focuses on the supply of tissues and the role of the OPOS in procuring 

tissue. No other inquiry has been undertaken to assess their performance of this role. 

The National Organ Transplant Act requires that OPOS have arrangements with tissue 

banks for tissue procurement. How well they perform this role can have a significant 

bearing on recovering a sufficient supply of high quality tissue for transplantation. It is 

true that the shortage of tissue is not as critical a national problem as is the shortage 

of organs. Yet the demand for transplantable bone tissue is potentially unlimited, and 

could result in a shortfall. Indeed, for certain “specialty tissues,” such as femurs and 

patellar tendons, shortages may already be occurring. 

Few sources of data are available to accurately measure the increase in demand for 

bone tissue. According to one source, an investment firm, bone tissue transplants in 

the United States increased from 155,000 in 1981 to 375,000 in 1990. More 

importantly, in 1981, only 3 percent of all bone transplants--or 5,000 of the 

155,000 procedures--used tissue from donors; the other 97 percent used the 

individual’s own bone. By 1991, donor tissue was employed in 53 percent of these 

transplants. The investment firm cites a number of factors, such as aging of the 

general population and greater acceptance of donor tissue among surgeons, as 

indicators that the demand for tissue will continue to grow.’ 

2

The OPOS already are involved in tissue banking by virtue of their-involvement in 

organ procurement. As much as 60 percent of bone tissue used for transplantation 

comes from donors of solid organs--kidneys, livers, hearts, lungs, and pancreata.s One 

prominent researcher, Dr. Jeffrey Prottas of Brandeis University, has pointedly 

summarized the issues central to Federal concerns about tissue procurement and the 

role of the OPOS as follows: 

Supplying bone cannot be a side-effect of the OPO referral 

system. . . . Insofar as the OPO system of hospital 

development and professional education is oriented solely to 

the needs of organ transplantation, it must miss innumerable 

opportunities to locate bone donors and to encourage bone 

donor referrals. The need for bone cannot be met as an 

afterthought of the need for organs. How to connect bone 

and organ banking is the basic question facing the tissue 

procurement community and government policy-makers.9 

This study examines the interaction between OPOS and tissue banks at the recovery stage, 

where the supply of tissues for transplantation is established. Despite differences between 

organ and tissue transplantation, there are similarities in the critical stage of recovery. 

Procuring tissues and organs depends on access to and cooperation of hospitals and 

medical personnel to identify potential donors. Approval from family members must be 

obtained. Excising both organs and tissues requires the use of surgical techniques. 

METHODOLOGY 

In May 1993, we conducted a mail suxvey of each of the nation’s 66 Medicare-certified


OPOS; 63 OPOS (95 percent) responded, although we made the decision to exclude


1 OPO from our analysis. This left us with useable responses from 62 of the


remaining 65 OPOS. During site visits to four OPOS, we interviewed staff from the


OPO, local tissue banks. and local hospitals, and we reviewed documents related to


their tissue banking activities.


In addition to the mail survey and site visits, we conducted telephone interviews with


staff from 15 OPOS; Federal officials from the Food and Drug Administration and the


Division on Transplantation in PHS, and from the Health Care Financing


Administration (HCFA); and staff from relevant organizations, including the


Association of Organ Procurement Organizations, the AATB, and the United Network


for Organ Sharing (UNOS), which holds the Federal contract for the Organ


Procurement and Transplantation Network. We also conducted a focus group with


directors of five tissue banks during the August 1993 AATB scientific meeting.


Appendix B contains a detailed description of our methodology.


We conducted this study in accordance with the Quality Standards for Inspections


issued by the President’s Council on Integrity and Efficiency.


3

FINDINGS -


ALL 62 OPOS RESPONDING TO OUR SURVEY PARTICIPATE IN TISSUE 

RECOVERY TO SOME DEGREE. 

The National Organ Transplant Act requires that OPOS have arrangements to


participate in tissue banking. However, neither the Federal government nor the


OPTN provides direction as to how this involvement should take place. The 62 OPOS


that responded to our survey--95 percent of all OPOs--use two basic models for tissue


recovery: They either refer donors to tissue banks, or they perform the actual


recovery themselves. Within each of these basic models, there is substantial variation.


Many OPOS are constantly evaluating their involvement, and it is important to


recognize that the arrangements described here reflect only a point-in-time, the spring


of 1993. In fact, the volatility of the arrangements is reilected by the fact that at least


five OPOS had substantially changed their arrangements over the past year.


i%i-ty-four OPOS refer potential donorx to tkwe bark 

In 16 of these 34 OPO service areas, only 1 tissue bank operates. In these areas, a 

referral would typically be handled as follows: A staff member at an OPO or a tissue 

bank receives a call about all potential donors, both organ and tissue, through a 

central telephone number. The staff member asks one question: “Is the donor on a 

ventilator?” If the answer is yes, the donor is a candidate for organ donation, and the 

call is referred to the OPO; if the answer is no, there is no opportunity for organ 

recovery, and the call is referred to a tissue bank. 

In 18 other OPO service areas, however, OPO staff and tissue bankers described to us 

situations in which multiple tissue banks operate and compete for available donors. 

The following two examples describe how referrals are made in such areas. In one 

city, a hospital calls the OPO first when it identifies a potential organ or tissue donor. 

If the hospital has an arrangement with any of the four tissue banks in its area, the 

OPO will inform that bank, which sends out a technician to handle the recovery. If 

the donor hospital has no such arrangement, the OPO calls one of the four banks on a 

rotating basis. In another city, dissatisfaction with service from two available tissue 

banks led the OPO to encourage a third bank to enter the service area and to receive 

all referrals from the OPO. 

Some of these tissue-referral OPOS have little interest in being actively involved in 

tissue banking beyond referring donors. These OPOS define their mission to be ogan 

procurement and distribution, not tissue recovery. Their primary motivation for 

participating in tissue banking, even to this limited extent, is to protect their organ 

relationships with hospitals, who may view them as the major procurement agency in 

the area. 

4

In other places, independent tissue banks already were operating, SO:the Opo saw no


need for further involvement, beyond cooperating with the existing tissue banks.


These OPOS view coordinating with tissue banks as important for their own


relationships with hospitals, because it gives them an opportunity to respond to


donation referrals. They reason that even if the donor is inappropriate for organ


donation, when a future opportunity for organ donation arises the hospital will be used


to calling the OPO for donation. The OPOS view this as an opportunity to increase


donation awareness and expand their hospital constituency beyond transplant


surgeons.


Sixteen of these 34 OPOS reported that they charge tissue banks a fee for referring


bone donors to them. These fees span a wide range. Five of these 16 OPOS charge a


referral fee of $100 or less, 5 charge between $100 and $500, 3 charge between $500


and $750, and 3 charge more than $1,000. The differing fees do not always cover


comparable costs. Some OPOS use the fees only to offset direct costs incurred in


referring tissue donors. For example, one OPO reported that it charges a fee of $35


per hour to cover the wages of an OPO procurement coordinator who assists the


tissue bank. At the other extreme, the director of an OPO that charges $1,200


indicated that its fee also covers operating room costs which are billed to the OPO,


rather than directly to the tissue bank.


Eighteen of the referral OPOS, however, do not charge fees for tissue referral. Staff


at these OPOS told us that they simply consider referral of any donor to be part of the


donation process, and they do not expect to be compensated.


llventy-eight OPOS recover tiwue themselves. 

The 28 tissue-recovery OPOS use three basic approaches. At the most comprehensive 

level, nine of these OPOS operate full-service tissue banks, either as part of the OPO 

or as a sister corporation within the overall OPO corporate structure. These 

comprehensive organ and tissue banks recover, process, and distribute tissue within 

their own semice area. In addition, they may contract with OPOS in other areas to 

process their tissue and to distribute it back to that OPO’S service area. 

Twelve of the 28 OPOS recover and distribute tissue. After recovery, the OPO ships 

the tissue to a tissue processor. That processor might be one of the comprehensive 

OPO-based tissue banks described in the previous paragraph, or it might be an 

independent tissue bank or tissue processor. After being processed, the tissue is 

returned to the OPO, which distributes it to local practitioners. 

Finally, seven OPOS just recover tissue. These OPOS have a contractual relationship 

with a tissue bank, which then processes and distributes the tissue. Many observers 

may not consider these OPOS to be extensively involved in tissue banking. They are, 

however, clearly involved in recovering tissue, including obtaining consent, screening 

donors, and performing the surgical excision. 

5

We identified four major reasons for OPO involvement in tissue recovery and, for 

some OPOS, processing and distribution. First, some OPOS see an opportunity to fill 

a void, by being able to provide a service (and a product) that local surgeons can use. 

In fact, in many of the arrangements in which an OPO only recovers tissue, the 

processed tissue is distributed back to that OPO’S local area. 

Second, by coordinating organ and tissue recovery more effectively, OPOS expect to 

provide better service to hospitals, making it easier for them; we heard the term “onestop shopping” to describe this goal. For other OPOS, tissue recovery is just a logical 

extension of their organ procurement activities. 

A third reason for OPO involvement in tissue recovery is to keep some control over 

donation in general, and to guard their access to hospitals. In areas where they feel 

that other tissue banks may be performing poorly, the OPOS cited a need to protect 

their reputation in order to protect their source of donors for organs. 

Finally, those OPOS involved in recovery have a substantial financial interest. We did 

not undertake a comprehensive financial analysis of tissue banking and OPOS; 

however, the following examples illustrate the monetary side of such a business. The 

director of one OPO told us that this year his OPO expects to realize gross revenues 

of about $1 million from recovering and distributing tissues; this would yield a net 

operating surplus, or profit, of between $50,000 and $100,000. At another OPO, the 

staff informed us that tissue banks typically pay OPOS between $5,000 and $6,000 per 

donor for performing recovery services; this amount is sufficient to cover their direct 

recovery costs--staff, operating room time, supplies, transportation--as well as a portion 

of their allocated overhead costs. 

THE OPOS’ COMMITME NT TO TISSUE RECOVERY VARIES WIDELY. 

PERFORMANCE DATA SHOW THAT THEY HAVE NOT TAKEN FULL 

ADVANTAGE OF OPPORTUNITIES TO OBTAIN TISSUE FROM POTENTIAL 

DONORS. 

The OPOS show a wide range of success in referring donors or recovering their tissue.


The range may not be surprising, given the lack of guidelines or standards for


performance in this area. Nevertheless, it raises questions about why some OPOS are


recovering more tissue or referring more donors than others. Are those that recover


more tissue performing more effectively or efficiently? Are those at the lower


performance levels simply not paying attention to tissue donation as they carry out


their organ procurement activities? Are they missing opportunities to identify donors


and recover tissues?


As part of our review, we developed three performance indicators to measure OPOS’


involvement in tissue recovery. One of these performance indicators applies to OPOS


that refer potential tissue donors to tissue banks, and two of these performance


indicators are relevant for OPOS that recover tissue themselves. For each of these, we


6

first describe the performance indicators; we then examine the range of OPO 

performance, utilizing 1992 data that the OPOS reported to us. Importantly, 

these data are for one year only; an OPO’S performance could change substantially 

from year to year. 

�	 Organ Donors Referred to Tissue Banks: For the 34 OPOS that refer potential 

tissue donors to tissue banks, we measured the percentage of organ donors who 

were referred for tissue donation. Theoretically, at least, every organ donor is 

a potential tissue donor; this performance indicator assesses the degree to which 

an OPO actually refers its organ donors for tissue donation. 

i%ee of there OPOS reprted that tky referred all of their ogan donom for tksue recovery. At 

the other extreme, 2 OPOS reported that they refereedfreer than 20 percent of organ dorunxfor 

tiwue donah”on. 

TABLE 1 

Percentage of Organ Donors Referred 

for Tissue Donation in 

OPOS that Refer Tissue Donors, 1992 

Percentage of Organ Donors Number of OPOs 

Referred for Tissue Donation 

II fewer than 20 % I 2 

II 21%-40% I 4 

II 41%-60% I 10 

II 61%-80% I 9 

81%-100% 4 

n = 29 (of 34) OPOS that refer tissue donora and that supplied sufficient data for analysis. 

source OIG survey of OPOS, May 1993 rneart= 58.4 Yo 

Clearly, for the 4 OPOS in the highest catego~, referral for tissue donation is routine;


3 of these OPOS actually referred all of their organ donors, and the fourth referred


90 percent of its donors. These data also show that some OPOS may not be giving full


consideration to tissue donation. Certainly, those OPOS that fall at the low end on


this performance indicator--for example, the 6 OPOS that refer fewer than 40 percent


of their organ donors for tissue donation--appear to give little attention to tissue


referral.


This performance indicator raises questions about whether and how the number of


tissue donors could be increased. Do the OPO staff have incentives to refer donors to


tissue banks? Are the OPO staff adequately trained to discuss tissue donation and


7 
recovery with donor families’? Would better marketing and outreach by tissue banks 

alleviate this shortfall? Would more cooperation between tissue banks and OPOS 

generate more referrals? 

�	 Organ Donors Providing Tissues: For the 28 OPOS that recover tissue, we 

measured the percentage of organ donors from whom they recovered both 

organs and tissues. This performance indicator assesses the emphasis that an 

OPO gives to organ donors as a source of tissue. 

?ke pexentage of organ donotx from whom these OPOS recovered both organs and tksue 

rangedfrom a high of 43 percent to a low of 6 percent. 

TABLE 2 

Percentage of Organ and Tissue Donors 

in OPOS that Recover Tissues, 1992 

Percentage of Organ Donors Number of OPOS 

from whom OPO also Recovered 

Tissues 

fewer than 10 % 2 

II 11%-20% I 9 II 

II 21%-30V0 I 7 II

II , 

31%-40% 5 I 

41%-5070 2 

n = 25 (of 28) OPOS that recover tissue and that supplied sufficient data for analysis. 

source OIG suwey of OPOS, May 1993 mean = 22.8 % 

Even in those OPOS at the highest level on this indicator, fewer than one-half of all


organ donors also donate tissue. An organ donor’s family may not consent to tissue


donation. The nature of the consent process, the length of the forms, the nature of


the surgical recovery of tissues, and the publicity given to organ donation may mean


that some families are less likely to give consent for tissues. At one OPO, for


example, the staff informed us that only about 50 percent of organ donor families also


consent to bone donation.


Further analysis of these data, however, reveal that those OPOS that are most involved


with tissue banking tend to fall towards the higher end on this performance indicator.


Four of the 6 “comprehensive OPOs’’--those that recover, process, and distribute


tissue--procured tissue from more than 25 percent of their organ donors. This number


compares with 4 of the 11 OPOS that recover and distribute tissue, and 2 of 8 OPOS


that only recover tissue. The implication, not surprisingly, is that those OPOS that are


8

more involved with tissue banking are likely to put greater effort into tissue recovery. 

This emphasis may result from factors such as a greater financial interest, or it may 

result from an organizational culture that encourages and supports tissue procurement. 

�	 Ratio of Tissue Donors to Organ Donors: For the 28 01’OS that recover 

tissue, we measured the ratio of tissue donors to organ donors. This indicator 

assesses the attention that an OPO gives to nonorgan donors as a source of 

tissue. 

Three of these OPOS reported more than 150 tirsue donon for evey 100 organ donors. At the 

other extreme, 3 OPOS procured tksue from fewer ~han20 tirsue dono~ for every 100 organ 

donom 

TABLE 3 

Ratio of Bone Donors to Organ Donors in 

OPOS that Recover Tissues, 1992 

1 

Number of Bone Donors per Number of OPOS 

100 Organ Donors 

fewer than 50 I 12 II 

51-100 5 

101-150 5 

II more than 150 I 3 

n = 25 (of 28) OPOS that recover tissue and that supplied sufficient data foranalysiS. 

source OIG survey of OPOS, May 1993 mean = 77.0 

This measure addresses OPOS’ performance in looking for tissue donors outside of 

their traditional pool of organ donors. The data presented in table 3 are based on 

donors who provided tissues only. We also analyzed data on tissue donors from whom 

the OPO also recovered organs and found a similar distribution. 

These data are consistent with the data presented in table 2. Those OPOS that 

provide the most comprehensive tissue banking services--recovery, processing, and 

distribution--tend to have higher rates of tissue procurement than do other OPOS; 

OPOS that both recover and distribute tissue have higher rates than those that recover 

tissue only. Three of the 6 comprehensive tissue banks procure tissue from more 

tissue than organ donors, as do 4 of the 12 OPOS that both recover and distribute 

tissue. Just one OPO that only recovers tissue is above that level. 

9

TENSIONS EXIST BETWEEN ORGAN PROCUREMENT AND TISSUE 

RECOVERY. IF THESE TENSIONS INTENSIFY, THEY COULD HAVE 

ADVERSE CONSEQUENCES FOR THE SUPPLY OF TISSUES AND OF 

ORGANS. 

Inherent differences between o~an procurement and tiwue recovery can limit OPOS’ and tksue 

banks’ willingruxsto work together. 

Although organ procurement and tissue recovery are intertwined in many aspects, they 

remain quite different. To some degree, these differences reflect higher prestige 

generally accorded to organ procurement and transplantation than to tissue recove~ 

and transplantation. Organ transplantation is considered to be a life saving procedure, 

while tissue transplantation is viewed as life enhancing. Renowned surgeons perform 

organ transplantation in a limited number of federally approved transplant centers, 

while tissue transplantation is part of routine surgery performed at most community 

hospitals. 

The Federal government has designated organ procurement organizations, which 

operate with virtual monopoly powers in a defined territory, and has set up a special 

program within Medicare to pay for organ recovery and transplantation. On the other 

hand, no Federal regulation governs how tissue banking is organized, multiple tissue 

banks compete with each other in many areas of the country, and payment is no 

different than for any other hospital supply. 

Different risk-benefit calculations also apply for transplanting organs and tissues. 

Because vital organs are life-saving and scarce, potential recipients are likely to take 

greater risks with the absolute safety of an organ than would be the case for tissue 

transplantation. The person who is facing death unless he receives a kidney or liver 

may be more willing to risk using a donated organ than someone who needs a 

transplanted tendon to gain full function of the knee joint. Both organ and tissue 

donors are subject to extensive screening and testing to minimize the risk of 

transmitting infectious disease. 10 However, the short time frame in which organs must 

be recovered, transported, and transplanted means that lengthy testing--such as blood 

and tissue cultures--is not possible if the organs are to remain viable. Tissue banks, on 

the other hand, can take advantage of the nonurgent nature of tissue transplantation 

to conduct a comprehensive testing of a tissue donor. 

As part of their testing and screening, tissue banks also may conduct extensive 

interviewing of the donor’s family in an effort to rule out behaviors associated with 

HIV or other infectious diseases. In fact, this more extensive interviewing of family 

members and acquaintances was cited to us by several OPO staff as being insensitive 

to a grieving family, and not meeting their needs for support; tissue bankers, however, 

cite an obligation to do everything possible to protect the recipient of the tissue from 

transmission of infectious disease. 

10

In some instances, according to OPO staff, tissue banks fail to understand hospitals’ 

concerns and needs. As a result, the OPO simply may not refer a donor out of fear 

that the tissue bank may harm its relationships with hospitals. An OPO director told 

us about a recent event that illustrates this concern. Nurses at a local hospital that 

previously had referred organ donors called the tissue bank about a potential donor, 

but no one returned their call. An hour later they called the OPO to complain. The 

OPO director eventually tracked down the tissue bank recovery team in the operating 

room at another hospital. But the team never called the hospital. The director noted 

that, “The donor was lost, plus the hospital is less likely to want to hassle with this in 

the future. The hospital had given us six organ donors per year, but we haven’t had 

one from it in 6 months.” 

Despite the concerns cited here, in many areas the relationship between tissue banks 

and OPOS appears to be working well, In these areas, OPO and tissue bank staff 

report that they focus efforts on encouraging donation in general terms--not in 

separating organs and tissues in their work with hospitals. 

Competition for donorx among multiple tiwue banks coukl threaten hospi[ak’ eagerness to work 

with OPOS and tirsue banlm 

Unlike OPOS, tissue banks have no defined service area in which they operate.


According to our survey, one-haIf of the OPOS reported that more than one tissue


bank operates in their service area. Where multiple tissue banks operate, the


competition for donors can become intense. The fear, from the OPO perspective, is


that competition among multiple tissue banks can damage the OPO’S relationships


with hospitals, which many OPO staff believe are already tenuous.


Tissue banks may compete for referral contracts with hospitals that will guarantee they


will be contacted when potential donors are identified. For example, the director of


one OPO told us that in the past year three new tissue banks have solicited hospitals’


support for their services; but she raised concerns that these contacts are very time-


consuming and create confusion for the hospitals. In another part of the country,


nurses at one hospital told us that a new tissue bank approached the hospital


administration about using its services, claiming that if the hospital failed to comply, it


would bring suit on the basis of restraint of trade.


The competition for donors also may focus on providers of care. An example relayed


to us by staff nurses on the intensive care unit in one hospital illustrates how this


competition takes place. An orthopedic surgeon on the hospital staff had used tissues


from one of the local tissue banks. The tissue bank convinced the surgeon that the


nurses must now refer donors to it, presumably to pay back the tissue bank for


supplying the original tissue.


Seeking hospital cooperation in organ donation entails constant education by the


OPO. Even large medical centers yield few organ donors. In order to obtain organs


from as many potential donors as possible, OPOS have a tremendous vested interest in


11

keeping their referral relationship with hospitals working well. Tissue banks, on the


other hand, report that obtaining donors is the bottleneck in ensuring an adequate


supply of tissue, just as it is for organs. Tissue bankers cite the privileged position that


OPOS have with respect to access to hospitals. This OPO access means that tissue


banks are, at least to some degree, dependent upon the OPOS for tissue donor


referrals.


For some--but by no means all--OPO directors, the solution to problems caused by


multiple tissue banks lies in designating a single tissue bank for each service area,


along the lines of the OPO service area designation. For other OPO directors, as well


as tissue bankers, such a solution would do little to solve the donor supply problem.


Instead, they support tissue bank competition, so long as it is based on meeting the


service needs of hospitals. One OPO director typified the comments of others when


he told us that, “selection of a tissue bank still boils down to who serves the hospital


best.”


SOME OPOS AND TISSUE BANKS HAVE DEVELOPED EFFECTIVE 

PRACIKES TO IMPROVE ORGAN AND TISSUE DONATION. 

During our mail survey, interviews, and site visits we sought information from OPOS 

and tissue banks about what they considered to be effective practices to improve 

donation and coordination between organ and tissue donation. Based on the 

descriptions and results reported by these officials, the following practices appear to 

be worth further consideration by other OPOS and tissue banks. 

Some OPOS and &me bank are working together to facilitate communication and 

cooperation. ?hese ejiorts include a central telephone system to receive all donor re$erralrand 

w“tten agreemenfi specifying referral arrangements among OPOS and tksue bank 

Identification of potential organ and tissue donors is a relatively rare event in most 

hospitals.11 As a result, when a potential organ or tissue donor is identified, hospital 

staff may not be clear about which organization to call, how to proceed, and what 

organs or tissues a donor might provide. Because of this confusion, potential donors 

may be lost to the system. The OPO and tissue banks in some areas are working 

together to address this problem and to improve service to hospitals. 

In several areas, OPOS and tissue banks use a central telephone number to coordinate 

donor referral for both organs and tissue. One OPO reported to us that “we have had 

only one phone number for referrals in our area for 10 years. This is essential to 

achieve best support from donor hospitals.” The goal of this arrangement is to save 

hospitals from having to make calls to several agencies for a multiple tissue donor. 

Instead, the OPO can then make the referrals to the appropriate agencies. Another 

OPO, operating in an area with two tissue banks, reports that both tissue banks have 

agreed to utilize the OPO’S donor hotline for tissue referrals within the OPO service 

area. This single number is included in each tissue bank’s hospital development 

12

materials, as well as the OPO’S materials. The OPO coordinators screen all calls and 

exclude unacceptable tissue donors on the basis of screening criteria that were jointly 

established and agreed to by the tissue banks and OPO. 

Some OPOS and tissue banks also have developed written referral arrangements to 

clarify their respective roles. An example of such an arrangement is the Transplant 

Council of the Rockies, which consists of Colorado Organ Recovery System (OPO), 

Mile High Transplant Bank (tissue bank), the Colorado Eye Bank, and the Rocky 

Mountain Lions Eye Bank. The Council agreement specifies the manner in which the 

OPO, tissue bank, and eye banks share referrals. Council members have agreed to 

guidelines and standards intended to maintain high quality service to the area 

hospitals. For example, each organization must be certified or accredited by the 

appropriate national body, such as HCFA for the OPO, the AATB for the tissue bank, 

and the Eye Bank Association of America for the eye banks. The organizations have 

agreed to participate in a neutral arbitration system to resolve disputes. They collect 

regional referral and recovery data on a quarterly basis to provide information on 

outcome of referrals, recovery by donor. and disposition of recovered organs and 

tissues. The organizations also share expenses for professional education and hospital 

development, 

Some OPOS have established programs under which hospitals routinely refer all deaths to the 

OPO to increase the number of donor referrak 

Hospital staff may not refer a potential donor because they assume--perhaps 

incorrectly--that a particular patient was inappropriate for donation. Rather than rely 

solely on the hospital staffs judgment, OPO or tissue bank staff believe themselves to 

be more knowledgeable about donor appropriateness. They prefer to make judgments 

about donor suitability on the basis of the OPO’S or tissue bank’s own screening 

criteria. 

Six OPOS informed us about their programs under which hospitals routinely refer all 

deaths to the OPO for consideration of organ and tissue donation. The decision on 

whether the deceased individual is appropriate for donation then rests with the OPO. 

The OPOS reported that they implement this practice on a hospital-by-hospital basis, 

beginning with larger hospitals that have higher numbers of donors. One OPO which 

has implemented this approach notes that it is difficult to get this system started, 

because it requires changes in hospital routines. But the OPO estimates that routine 

referral has led to a three-fold increase in calls to their office, and has been of 

particular benefit to tissue referrals (although less so to organ referrals). Routine 

referral may, however, add some cost. One OPO reported that it had to hire a nurse 

to be on duty all night in order to receive these calls and make judgments about 

whether the potential donor is acceptable. 

13

RECOMMENDATIONS


Our recommendations arise from the statutory requirement that OPOS “have 

arrangements to cooperate with tissue banks for the retrieval of tissue.” While activity 

is taking place at the local OPO level, little national attention has focused on this 

mandate. Over the last decade, there has been tremendous growth in the use of bone 

tissue in surgical procedures, and the procurement of that tissue is closely intertwined 

with the procurement of organs. Because it can have a significant impact on overall 

OPO performance, the relationship between tissue banks and organ procurement 

organizations can no longer be relegated to secondary status. 

Both PHS and HCFA have important roles to play in this respect, and we direct 

recommendations to each of these agencies. We believe that the Department needs 

to provide some national guidance t; establish accountability for the ~equirement 

regarding OPOS and tissue banks. We have developed our recommendations to 

further that objective. 

l%e PHS should provide some general overnightand guidance for OPOS regardingtheir 

airangementi with tissue banks and their tissue recovery activity. 

The Division on Transplantation within PHS provides general oversight of the nation’s 

organ procurement system and administers the contract for the Organ Procurement 

and Transplantation Network. Our recommendation means that PHS would extend its 

oversight of OPOS to include some guidance on their involvement with tissue banking, 

in light of the requirement in the National Organ Transplant Act. This oversight and 

guidance could take several forms. 

First, we encourage PHS to collect routine data about OPO involvement with tissue 

recovery. Data to be collected might include information on what arrangements an 

OPO has in place for tissue recovery or referral of potential donors. These data might 

also include statistics on performance indicators such as the number of potential tissue 

donors referred, number of donors from whom tissue was recovered, and number of 

donors providing both organs and tissue. The PHS could use UNOS, the OPTN 

contractor, to gather this information through the current OPO reporting structure. 

Second, PHS could play a useful role by disseminating information about effective 

practices that OPOS have undertaken to work with tissue banks. We have described 

two such practices in this report--steps to facilitate communication and routine referral 

of all deaths. We expect that other practices also merit consideration. An evaluation 

of these efforts and distribution of the findings to OPOS and tissue banks could 

complement ongoing PHS efforts to encourage organ donation. 

Third, we urge PHS to keep a watchful eye on the types of tensions between OPOS 

and tissue banking that we describe in this report. It is important that PHS monitor 

14

these tensions and determine if they are intensifying to a degree that jeopardizes the 

supply not only of tissues, but of organs as well. We also encourage PHS to consider 

ways in which it can help OPOS and tissue banks overcome these tensions. 

The HCFA shouki include an assessment of OPOS’ pe~ormance in lksue recovery as part 

of the OPO recerhjication process. 

This recommendation would require that an OPO must meet certain performance 

expectations with respect to its involvement in tissue banking in order to maintain its 

certification for Medicare and Medicaid. 

In light of the statutory requirement, we believe that some measure of accountability 

for OPO performance in tissue recovery is warranted. At present, HCFA responds to 

this requirement by asking OPOS to “document your affiliation with tissue banks for 

the retrieval, processing, preservation, storage and distribution of tissues to assure that 

all useable tissues from potential donors are obtained.”*2 

Based on our findings in this report that wide variation exists in OPO performance in 

tissue recovery, we have reason to question whether all useable tissues are indeed 

being obtained from potential donors. We believe that HCFA could improve OPOS’ 

accountability and performance in tissue recovery by examining data that substantiate 

these organizations’ participation in this activity. 

We recognize that recertification focuses primarily on an OPO’S performance with 

respect to organ procurement and distribution. However, the law explicitly requires 

that OPOS also participate in tissue recovery. Establishing accountability for this 

requirement is not inconsistent with reviewing organ procurement efforts, and it would 

help meet expectations that all useable tissues are obtained from donors. 

The HCFA could utilize performance indicators to assess how well OPOS are meeting 

the requirement that they have arrangements to cooperate with tissue banks. In this 

report, we identify three such performance indicators that offer a starting point for this 

examination. One of these performance indicators can be applied to OPOS that refer 

potential tissue donors to tissue banks, and two can be applied to OPOS that recover 

tissue themselves. These three indicators revealed wide variation in the performance 

of OPOS with respect to their tissue recovery and referral activities. The HCFA could 

use indicators such as these to measure that performance, or it could develop its own 

tools to assess an OPO’s performance in recovering tissues. 

15

COMMENTS ON THE DRAFT REPORT


Within the Department of Health and Human Services, we received comments on this 

report from the Public Health Semite, the Health Care Financing Administration, and 

the Assistant Secretary for Planning and Evaluation. We also received comments from 

the United Network for Organ Sharing, the American Association of Tissue Banks, 

and the Association of Organ Procurement Organizations. Appendix C contains the 

full text of each set of comments. 

We are encouraged that the respondents agree that we raise legitimate questions 

about an important issue. It is clear that organ procurement organizations are 

intricately involved in tissue recovery by the very nature of the anatomical donation 

system. We also are compelled to note that the National Organ Transplant Act 

includes a role for OPOS in tissue recovery. As we indicate in this report, obtaining 

and allocating vascular organs is the primary task facing OPOS; while we also view 

tissue procurement as important, we do not imply that tissue recovery should take 

precedence over OPOS’ efforts to improve their organ procurement practices. 

Our interest is in ensuring that OPOS and tissue banks do not operate in a fashion 

that could be detrimental to the recovery and allocation of a scarce and valuable 

resource that relies on a voluntary system of donation. We are concerned about 

competition that could have a deleterious impact on organ procurement, about 

duplication of effort, and about organizations operating at cross purposes in their 

procurement activities. As a result, we believe that the Department has an important 

role to play in encouraging the coordination of organ procurement and tissue recovery, 

as was envisioned by Congress in legislation establishing the national organ transplant 

system. 

Overall, the comments share three major points. Below, we identify these points and 

offer our response to them. 

Additional resources would be needed for PHS to provide general oversight and 

guidance. 

The PHS concurs with our recommendation that the agency provide some general 

oversight and guidance for OPOS regarding their arrangements with tissue banks and 

their tissue recovery activity. That agency, AATB, and UNOS indicate, however, that 

additional resources would be needed to implement this recommendation, and ASPE 

calls it infeasible at this time. 

We are keenly aware that funding for new initiatives is limited. In this instance, 

however, we believe PHS could begin providing general oversight and guidance 

without incurring extensive new expenditures. Our intent in making this 

recommendation is not to create a new reporting structure; nor do we wish to impose 

a major reporting or data processing burden on agencies within the Department, on 

16 
the OPTN, nor on the OPO or tissue banking community. We would be pleased to 

work with PHS toward this end. 

We believe that existing reporting systems can be revised incrementally to obtain these 

data with a minimum of expense and effort. As we note in our recommendation, we 

envision the collection of routine data. We anticipate that few data elements beyond 

those currently submitted for monitoring and guiding organ procurement would be 

needed. These elements could be incorporated easily with data that OPOS and tissue 

banks gather in their current business practices, and that OPOS report to HCFA, PHS, 

and UNOS. Our experience in conducting this study reinforces the availability of this 

information, as we found that OPOS had little problem in providing the data we used 

in this inspection. 

The specific performance indicators we developed may not be adequate to evaluate 

OPOs’ performance in tissue recoveV. 

Although AATB finds our performance indicators to be reliable indicators of the 

strength of OPO commitment to tissue recovery from cadaveric donors, HCFA, ASPE, 

and AOPO question the adequacy of our indicators. We believe that the indicators 

we present are quite sufficient to draw attention to questions that the Department and 

the organ and tissue transplant community should begin to address. We developed 

these indicators based on readily available data, and we are confident that other 

indicators would also show wide variation in OPO performance. 

At the same time, however, we are not wedded to these or any other particular 

performance indicators. Rather, we offer them as a starting point in deliberations 

around performance indicators for OPOS and tissue banking. We encourage HCFA 

and PHS to collaborate either to modi~ these indicators or to develop other indicators 

that will meet our intended purpose: to begin to hold OPOS accountable for their 

activities with regard to tissue recovery. We also believe that PHS and HCFA would 

find it useful to include representatives from professional groups, such as AOPO, 

AATB, and UNOS in developing any indicators, because of the expertise of these 

organizations and their constituencies. 

Including an assessment of OPO performance in tissue recovery as part of the 

Medicare recertification process is not feasl%le at present. 

Both HCFA and ASPE identi@ regulatory barriers to including an assessment of OPO 

performance with regard to tissue recovery as part of OPO Medicare recertification 

processes. We recognize that regulations needed to implement this recommendation 

have not yet been proposed, and that the Secretary has not expanded the list of 

organs to include tissues. 

17

The HCFA notes that any such effort is a long term initiative, which$must be preceded


by data collection and development of appropriate and valid performance indicators.


We believe that the long lead time that HCFA requires for such an effort makes its


own compelling case for initiating this activity sooner rather than later. Collecting


necessary data and developing more refined performance indicators are preconditions


for this assessment. Consequently, we urge HCFA to establish an appropriate


schedule to carry out such a proposal.


Technical Comments 

� FDA Interim Rule on Human Tissue Intended for Transplantation 

Subsequent to the preparation of our draft report, the Food and Drug Administration 

issued an interim rule to require testing for infectious disease, donor screening, and 

recordkeeping to help prevent the transmission of AIDS and hepatitis through human 

tissue used in transplantation. We have modified the text of this report to provide 

note of this interim rule, published at 58 Fed. Reg. 65,514, December 14, 1993. 

� Number of OPOS 

The HCFA comments note that the correct number of OPOS is 66, rather than 65 as 

we report in the text. The larger number includes the OPO of Puerto Rico which we 

excluded from our analysis due to its low level of procurement activity, as we note in 

our methodological appendix. We also reference this exclusion in endnote 3 to the 

text. 

18

APPENDIX A -

AN OVERVIEW OF TISSUE BANKING. 

RECOVERY, PROCESSING, AND DISTRIBUTION 

RECOVERY 

Recovery is the first stage in the tissue banking process. It involves four steps: 

identification and referral of the potential donor, consent to donation from the donor 

family, donor screening, and surgical recovery of the tissues from the donor. 

Identification and Referral of Donors 

Unlike organ donation, which requires that the donor be ventilator dependent,


virtually any death can be considered for tissue donation. Most tissue donors are


referred by hospitals, although medical examiners also are an important source.


Upon identifying a potential donor, hospitals may noti~ a tissue bank directly about


the possibility of donation, or it may call the OPO, which passes on the referral to the


appropriate tissue bank.


Consent 

Hospitals are required, as a condition of participation in Medicare, to ensure that 

families of potential donors are made aware of the option to donate organs and 

tissues. In addition to offering the option of donation, the hospital, OPO, or tissue 

bank must obtain consent from the donor’s next-of-kin. 

According to OPO staff with whom we spoke, the preferred approach to obtaining 

consent is a face-to-face conversation with the donor’s family. In the case of tissue 

donation, however, consent is often requested over the telephone. 

The form in which staff obtain consent can vary widely. For example, in some cases, 

the OPO will obtain consent using a blanket statement that authorizes donation of all 

organs and tissues. In other cases, the form will spell out specifically which organs and 

tissues the family wishes to donate. 

Screening 

If the family consents to donation, the tissue bank or OPO will screen the donor based 

on its own criteria for acceptance. The Centers for Disease Control (CDC) has 

published draft guidelines for donor screening, but the guidelines are voluntary. 

According to literature we reviewed13 and the staff from tissue banks and OPOS with 

whom we- spoke, donor screening is considered to be a very important step in ensuring 

the safety and quality of tissue. 

A-1

Screening generally includes assessing the potential donor’s social aild medical history. 

To identify any risk factors associated with transmitting diseases, the tissue bank 

assesses social history through interviews with family members, spouses, and/or sexual 

partners. The medical history includes blood tests, cultures, cause of death, and 

previous illnesses. Some, but not all, tissue banks require autopsies in their screening. 

Generally, a tissue bank reserves its final determination about the acceptability of the 

donor’s tissue until blood tests and cuiture results, and in some cases, autopsy results, 

are available, which could take several weeks. During this waiting time, the bank 

keeps the tissue in quarantine. 

Swgical Recovery 

If the donor passes the initial screens, tissue bank or OPO staff will surgically remove 

the tissue. Approaches to recovery vary among tissue banks. Some tissue banks 

recover tissue only in a hospital operating room under aseptic conditions; other tissue 

banks will recover tissue in the morgue or in a funeral home under clean--but not 

aseptic--conditions. If organs are also being donated, tissue recovery would follow the 

organ recovery, which takes place in the operating room. The time allowed to pass 

between death and recovery also varies among tissue banks. Although there are no 

definitive standards, those tissue banks we met with require recovery of tissues within 

12 hours of death if the body is not refrigerated, or 24 hours if the body is refrigerated 

within 12 hours of death. 

The qualifications of staff performing the surgical excision of tissues vary. The AATB 

has a certification program for tissue specialists. At some tissue banks the staff are 

nurses, physician assistants, or medical residents. At other tissue banks, however, staff 

with little or no medical training learn to do surgical recovery through on-the-job 

training. 

Once the tissues are surgically removed, the tissue bank reconstructs the donor’s body 

to allow for an open casket, should the family desire it. The tissue generally is 

wrapped and sent to a processing facility, where it is stored until final results of 

screening tests are available. 

PROCESSING 

Processing comprises three stages: processing, preservation, and labeling. We have 

seen estimates that between 30 and 40 organizations process bone, with 4 large 

processors dominating the field. Processors may process bone from several different 

tissue banks. 

A-2

Processing 

During this stage, any remaining soft tissue is removed from the whole bone. The 

bone is processed into the different sizes, shapes, or products required for eventual 

use. Generally, bone recovered under clean (i.e., nonsterile) conditions is subjected to 

some type of secondary sterilization, while bone recovered under aseptic conditions is 

not. 

Several approaches to secondary sterilization are used. Some banks process the bone 

using chemical treatment, such as ethylene oxide (ETO); research has linked ETO 

with carcinogenic properties, however, and it apparently has fallen from favor. 

Nevertheless, it is still used by some banks and the AATB has accreditation standards 

covering its use. Other banks sterilize bone, using either low-dose or high-dose 

gamma radiation; while those we spoke with indicate that high-dose radiation assures 

that the bone does not carry HIV, others maintain that such treatment reduces the 

osteogenic (bone regenerating) characteristics of the bone. Individual surgeons and 

bone processors prefer different methods, out of legitimate disagreements over which 

approach is best for their needs. 

Preservation 

Several basic approaches exist to preserve processed bone until it is transplanted.


Simple hypothermia is used for short term preservation (usually less than 10 days).


Deep freezing, at temperatures of -800 C, is used for longer-term preservation.


Cryopreservation, deep freezing at a controlled rate of temperature decrease, also is


used for longer-term preservation. Tissue may also be freeze-dried (Iyophilized). This


process involves the removal of virtually all water from the bone. Freeze-dried tissue


can be maintained at room temperature, but must be dehydrated prior to use.


Labeling 

Once tissue has been processed and preserved, it is packaged for use. Each unit of 

tissue receives a label. Typically, the label will contain an identifying number for the 

donor, information on how it was processed and treated, and instructions for storage 

and use (e.g., thawing or dehydrating). 

DISTRIBUTION 

Dk~”bution 

Tissue processors may distribute bone directly to hospitals, surgeons, and dentists for 

their use. In other cases, the processor may return the tissue to the originating OPO 

or tissue bank, which then distributes the tissue. In still other situations, a processor 

may send the tissue to another tissue bank for distribution. Often, procurers negotiate 

with processors and/or distributors for distribution back to the donor’s area or donor 

A-3

hospital--even if the procurer is not the one distributing the bone. During the course 

of our inspection, we also heard about “tissue brokers, “ individuals who buy and sell 

surplus bone tissue to meet the needs of individual surgeons or hospitals. We also 

heard that some companies distribute tissue procured outside the United States. 

Recordkeeping 

Tissue banks include a response card with each unit of bone. That card includes the 

identifier number. The tissue banks rely on cards being completed and returned by 

the surgeon, hospital, or dentist implanting the bone. Tissue banks informed us that 

the response rate on these cards varies widely. We heard figures that ranged from 

13 percent at one tissue bank to 90 percent at another. 

This record-keeping system, at least theoretically, would allow the tissue to be traced 

back to its donor. We heard examples, however, of cases in which the tissue could not 

be traced. For example, a surgeon may have privileges at more than one hospital; if 

that hospital lacks the tissue that he or she needs, the surgeon may simply “borrow” 

the tissue from the other hospital, with no notice in the medical record. In a recent 

incident reported by the AATB, the presence of Hepatitis C was discovered in tissue, 

but “tracking of the remaining grafts was complicated by incomplete hospital records 

and, in one case, by the repackaging of a single graft for multiple patients.”14 

A-4

APPENDIX B -


METHODOLOGY 

Mail Survgy of Oqan Procurement Oganizahons 

In May 1993, we mailed a sumey to directors of each of the nation’s Medicare-


certified OPOS to assess their involvement in tissue banking. This survey included


questions about the numbers of organs and tissues procured in 1992, OPO


arrangements for tissue recovery, effective practices for tissue recovery, and


vulnerabilities associated with tissue banking. We received responses from 63 OPOS.


We decided to exclude the OPO of Puerto Rico from the study universe because of its


low level of organ procurement activity (two donors in 1992). This left us with


responses from 62 OPOS, out of a universe of 65--a response rate of 95 percent.


Telephone Survey of Sample of OPOS 

Following the mail survey, we conducted more extensive telephone interviews with 

staff from 15 OPOS. We selected these OPOS based on the results of the mail sumey. 

We stratified the OPOS according to whether they recover tissue themselves or refer 

donors to a tissue bank. We selected OPOS from each strata in proportion to the size 

of the strata relative to the total number of OPOS responding to the survey. In 

deciding which OPOS in each strata to interview, we also gave attention to geographic 

distribution and to sponsorship (i.e., whether the OPO was hospital-based or 

independent). In addition to the 15 telephone interviews, we gathered similar 

information during a meeting with staff from one additional OPO. 

Site Vik”ts to OPOS 

We conducted visits to four OPOs: 

Regional Organ Procurement Agency of Southern California, Los Angeles, CA,


OPO of the University of Wisconsin, Madison, WI;


LifeNet Transplant Services, Virginia Beach, VA; and


Tennessee Donor Services, Nashville, TN.


During these visits, we interviewed staff of the OPO, local tissue banks, and local 

hospitals. Our visits also included a review of forms and procedures the OPOS utilize 

in their tissue-banking activities. 

B-1

Interviews with Federal OJiciak and National Associations ., 

We interviewed staff from PHS and HCFA who deal with organ transplantation to 

obtain information on federal policies addressing the OPO role in tissue recovery. 

Our PHS interviews included officials from the Division on Transplantation and the 

Food and Drug Administration. We also interviewed staff from UNOS, which holds 

the Federal contract for the Organ Procurement and Transplantation Network. 

We interviewed staff from national associations, including the Association of Organ 

Procurement Organizations, and AATB. During the August 1993 AATB annual 

scientific meeting we convened a focus group of staff from five tissue banks to obtain 

their views on issues related to OPO involvement in tissue banking. 

RevI”ewof Literature and Le@lation 

Our literature review included an examination of Federal reports on tissue banking, in


particular “Tissue and Organ Transplantation Assessment Report,” (PHS WorkGroup


on Organ and Tissue Transplantation, July 18, 1991). We examined legislation


introduced in the U.S. Senate in 1992 (S. 2908) by Senator Paul Simon, and 1993


legislation introduced by Congressman Ron Wyden (H.R. 3547) and Senator Simon (S.


1702). We reviewed testimony presented at hearings before the Senate Committee on


Labor and Human Resources, September 29, 1992, and the House Committee on


Small Business, Subcommittee on Regulation, Business Opportunities and Technology,


October 15, 1993.


Our study also included a review of medical and scientific literature on tissue banking.


B-2

APPENDIX C -


COMMENTS ON THE DRAFI’ REPORT 

AGENCY/ORGANIZATION PAGE


Public Health Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. C-2


Health Care Financing Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c-4


Assistant Secretaxy for Planning and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . c-7


United Network for Organ Sharing.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c-9


American Association of Tissue Banks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. C-11


Association of Organ Procurement Organizations . . . . . . . . . . . . . . . . . . . . . . . C-12


c-1 
%!(

*,L-, ~ 

.+’ % ~blic Health SefVI@ 

DEPART~NT OF HEALTH & HUMAN SERVICES / 

L 

‘+%+V~ Memorandum 

Date 

./@ll 201994 

From Assistant Secreta~ for Health 

“organ Procurement 

Subject Office of Inspector General Draft Report 

Organizations and Tissue Recoveg~ OEI-01-91-00250 

To Inspector General, OS 

on the 

Attached are the Public Health Senice (PHS) comments


subject draft report. Though we agree with the recommendation


directed to PHS, we note that to undertake.tpe StePSprogrammatic
 encouraged in the report would requ~re additional


resources.
 @LpzxzL Philip R. Lee, M.D. 

Attachment 

c-2 
PUBLIC HEALTH SERVICE (PHS) COMMENTSON THE OFFICE OF INSPECTOR 

GENERAL (OIG) DWWT REPORT “ORGAN PROCUREMENTORGANIZATIONS AND 

TISSUE RECOVERY, ” OEI-01-91-00250 

OIG Recommendation 

The PHS should provide some general oversight and guidance for


organ procurement organizations (OPO) regarding their


arrangements with tissue banks and their tissue recovery


activity.


PHS Comment


We concur with this recommendation, but note that it cannot be 

implemented as OIG envis~ons ana encourages without additional 

staffing resources or funds. As additional resources become 

available, the Health Resources and Senices Ad.MlnistratlOn’S 

Division of Organ Transplantation would foresee taking the 

following specific actions in response to this recommendation: 

I o	 Collect information regarding the arrangements that OPOS 

have made for tissue recovery and donor referral. 

Statistical data on the performance indicators suggested 

by OIG would be collected. 

o	 Disseminate information about effective arrangements 

between OPOS and tissue banks in order to facilitate the 

efforts of other OPOS i.n this area. A part of this 

activity could be the development of protocols for 

coordinating tissue recovery between OPOS and independent 

tissue banks. 

o	 Seine as a liaison between OPOS and tissue banks and 

monitor points of conflict between these two groups. 

This would include the development of performance 

standards for OPOS concerning tissue recovery activities. 

Activities envisioned under the first two bullets could be 

performed under contract. The third activity, which requires 

program liaison between OPOS and tissue banks, can only be 

performed using Federal staff. However, as noted above, staffing 

resources and contract funds are not currently available to 

perfmm these activities. 

. 

c-3 
. ,,..?.., -.+’ 

Jig) DEPART.ll ENT OF HEALTH & ~UNIA& SERI”lCES Health Care F]nanclng Admirrlstratlon 

-

“* ‘+~-,m > The Admlnlstrator

Washington, D.C. 20201 ., 

DATE MAR 21994 

@u~ 

FROM Bruce C. Vlad~ 

Administrator’ ‘ ~ * 

% 

SUBJECT Office of inspector General (OIG) Draft Report: Organ Procurement 

Organizations and Tissue Recovery (OEI-01-91-00250) 

l-o	 June ~.~~~s jWe\\Tn 

lnspecIor Generai 

We re~tiewed the above Subiect draft OIG report which examines the role of organ 

procurement organizations ~OPOs) in procur;ng tissues for transplantation. 

The study’s findings, taken as a whole, raise legitimate concerns about the efficacy of 

OPOS and tissue bank relationships and OK)S’ performance in assisting in the 

recovery of tissues. C1early, OPOS can play a key role in supporting and encouraging 

the recovery of tissues; however, we disagree with OIG’S recommendation that the 

Health Care Financing Administration take a more active role in the monitoring of 

OPOS’ involvement with tissue recovety. We have provided our detailed comments 

on the report’s recommendations for your consideration in the attached. 

Thank you for the opportunity to review and comment on this draft report. Please 

advise USif you would like to discuss our comments at your earliest convenience. 

Attachment 

C-4

Health Care Financing Administration’s (HCFA) Comments 

on Oifice of Inspector General (OIG) Draft Repom” -

“Organ Procurement Organizations (OPOS) and Tissue Recovery” 

0EI-01-91-O0250 

Recommendation 

HCFA should inciude an assessment of OPOS’ performance in tissue recove~ as part 

of the OPO recertification process. 

ResDonse 

The study’s findings, taken as a whole, raise Legitimate concerns about the efficacy of 

OPOS and tissue bank relationships and Ol?C)s’ performance in assisting in the 

recovery of tissues. However, we do not concur With the recommendation for two 

reasons. Firs~ performance indicators must be published in regulations before we 

can incorporate them into the OPOS’ survey and certification requirements. Neither 

current regulations nor proposed regulations (BPD-646-FC, Conditions of coverage 

for OPOS) include any performance indicators for tissue recovery. Secondly, we do 

not believe the three performance indicators used in the report are adequate for 

HCFA to use in evaluating OPOS’ performance and, potentially, denying certification. 

Our specific concerns are as follows: 

m	 The first indicator (Organ Donors Referred to Tissue Banks) does not 

account for the inherent variability in referral methods. No definition 

of “referral” k provided and we suspect the term may be applied 

differently. 

�	 The second indicator (Donors Providing Organ and Tissue) is used by 

OIG to capture the “emphasis that an OPO gives to organ donors as a 

source of tissue.” However, the report also notes that “fewer than half 

of all organ donors also donate tissue” and suggests a number of 

reasons for this phenomenon which have no bearing on OPO 

“emphasis” or commitment or the nature of OPO-tisstte bank 

re~ationships. No benchmark for acceptable or exemplary performance 

is provided for this measure. 

8	 The third study indicator (Ratio of Tissue Donors to Organ Donors) is 

not the appropriate measure of tissue recovery as a whole. We beIieve 

the real issue is the lack of availability of tissue donors throughout the 

community, rather than the level of tissue recovery by OPOS alone. 

c-5 
Page 2 . .


If the Public Heaith Semite (P13S) agrees to OIG’S recommendation to begin routine 

collection of data regarding OPOS’ involvement with tissue recovery, we wouid 

suggest further collaboration between PHS and HCFA to assure the data to be 

collected can be used by HCFA to develop performance indicators. Based upon our 

analysis of such data, l-ICF.4 may then determine the appropriateness of developing 

valid indicators and ixnpiementing a monitoring process using these indicators. We 

see the data collection, analysis, and possible development of performance indicators 

as a long-term initiative. 

Technical Comment 

The totrd number of OPOS referred to in the report (65) is incorrect. The correct 

number of OPOS is 66 nationwide. 

C-6

office or tne Secretarv 

DEP.% RT,%IENT OF HEALTH & HU.’WAN SERVICES 

# 

- .,+=;j~ Wastrlngton. 13.C. 20201 

20:
 June Gibbs Brown 

Inspector General 

FROM:	 Assistant Secretary for 

Planning and Evaluation 

procurement organizations SUBJECT: OIG Draft Report, llorgan 

(OPOS) and Tissue Recovery,” 0EI-01-91-00Z50 ‘-

COMMENTS 

Thank you for the opportunity to review the draft report in which 

you recommend that: 

o	 the Public Heaith Service provide some general oversight and


guidance for OPOS regarding their arrangements with tissue


banks; and


o	 the Health Care Financing Administration include an 

assessment of OPOS1 performance in tissue recovery as part 

of the OPO recertification process. 

The report bases its recommendations on the requirement in the 

Public Health Service Act that OPOS lthavearrangements to 

cooperate with tissue banks for the retrieval, pr0cessin9~ 

presemation, storage, and distribution of tissues as may be 

appropriate to assure that all usable tissues are obtained from


potential donors” (section 371b).


While I fully agree with the purpose of your recommendations, I


must disagree with the specifics of both. Although OPOS are


required to have cooperative arrangements with tissue banks~ the 

primary charge to OPOS under section 1138 of the Social SecurltY 

Act is to coordinate procurement of solid organs (human kidney, 

liver, heart, lung, pancreas, and any other human organ or tissue


specified by the Secretary) . To date, the Secretary has not 

expanded the statutory list to include tissue. Thus, requiring 

HCFA to evaluate OPOS’ performance in tissue recovery would 

exceed statutory authority. Also, additional PHS oversight and 

guidance to OPOS appears infeasible at this time.


The finding that OPOSI commitment to tissue recovery varies 

widely is not particularly revealing since nearly half of the 

OPOS also recover tissue; they would be expected to devote 

greater efforts to tissue recovery. In addition, evaluating 

tissue and organ recovery on the same scale is not practical 

because of disparate consent rates of next of kin regarding 

donation of both organs and tissue. 

C-7

Page 2 - June Gibbs Brown


Again, I appreciate your objective to enhance procurement of both 

solid organs and tissues. For some medical conditions, tlSSUeS 

may sene to enhance life. However, as the reporx acknowledges,


the critical shortage remains in life-saving organs. Also, some


tissues may be procured autologously, they SnOUld not be compared


with scarce cadaver organs.


In addition, please note that the recently proposed FDA


regulation implements testing requirements to “detect infectious


diseasesil in tissue donors. “Safety and quality” regulations


have not yet been promulgated.


e ‘can


David T. Ellwood


C-8

‘ 1100 BOLLOERS PARKWAY, SLITE500


F’(’)ST OFFICE 80x i 3770 

?, CHW)NV, VIRGINIA 23225-3770 

tl[CUTIVt 01 RK70R 

..f . Vl(ilcf 

February 3, 1994 

June Gibbs Brown


Inspector General


Department of Health & Human Services


Office of Inspector Generai


Washington, D.C. 20201


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bu.+ESS wOLF, MO. lWO.91

z08ERT M[NDEZ. M O 1991+2

Re:	 Draft Report on “Organ Procurement Organizations 

01-91-00250) 

Dear Ms. Brown: 

and ‘l%sue Recovery” (OEIThank you for providing us with the opportunity to comment on the Office of Inspector 

General’s dr@ inspection report entitled, “Organ Procurement Organizations and lissuc 

Recovery.” 

As you know, the United Network for Organ Sharing (UNOS) is a Virginia non-profit 

corporationthat operatestheNational Organ Procurernent.and Transplantation Netwo* (am 

under contract with the federai government and pursuant to the National Organ Transplant Act 

of 1984, as amended (NOTA). Among the duties assigned to the OPTN contractor under NOTA 

are responsibilities for developing and operating a national computer system for matching patients 

in need of organ transplantswith available donor organs, establishing the medicd cfi* @ 

which these donor organs are allocated among all patients who are registered with the national 

matching system and establishing membership criteria for transplant centers and organ 

procurement organizations (OPOS) that participate in the organ transplantation process. 

The draft report (at pages 1 and 4) states that the OPTN does not provide guidance about 

the arrangements for participation in tissue banking that OPOS are required to have under NOTA. 

Inciuded in the draft report’s recommendations (at page 14) is the following recommendation: 

. 

THE NATIONAL ORGAN PROCUREMEI+T- XND TRANSPLANTATION NEWORK 
June Gibbs llrown 

Inspector Generai 

February 3, 1994 

Page 2 

The PHS could use UNOS, the OPTN contractor, to gather this information [i.e., 

data about OPO involvement with tissue recovery] through the current OPO 

reporting structure. 

The draft report’s statements regarding the involvement of UNOS, as operator of the 

OPTN, in guiding OPO tissue retrieval processing, preservation, storage and distribution efforts 

is correcL We simply note that UNOS is not presently authorized under NOTA or pursuant to 

our contract with the federal government to participate in such activity. While we would ~ 

pieased to gather the information described in the draft report’s recommendation, there currently 

are no funds available for this task under the OPTN contrac~ Also, UNOS has no private 

funding available for this task. Therefore,implementation of this ~ommendation WO~d Wfie 

additional funding iromtiefederai governmen~ 

Again,wc appreciate the opportunity to comment on the Office of Inspector General’s 

draft report on “Organ Procurement Organizations and ‘Iissue Recovery.” If you have any 

questions regarding our comments, please do not hesita~ to con~t me. 

~P–4

. 

Gene A. Pierce 

Executive Director 

c-lo 
BOARD W CovfMoas 

American Association of Tiiue Banks 

FcbruaIY8,1994


June Gibbs&own


InspectorGcJJera~Offiwof theInspecforGeneml


Deparunent
 ofHeakhandHumanScmica 

330Independence Avenue,
SW

Washington,
 DC 20201


Dear Mrs.
Browm


lmuk youforaffording usthe opportunity torcvkw thehm~or G~~~ ~ W ~U~ed0~8~


Pmcwment Organizationsand T&sue ReccweTY. WrJhavereviewedthereportandofferthefollowrng 

cammenw 

TheXWPORdewxibes amsearoh effort that
appearsto beboththoroughandwellconstructedforitsintended 

purpose.Thethreeperformanceindicatorsyouselected arc reliable indiuttan ofthe strmgthofthe

commitment madebyOPOS totheoverall recowtyoftissue t30mcadaveric dcmotxYourf.ixxdiags am

conaktent withtheaneodotal repo!ts endcomplaints that membersofAmerican Association ofTissue


Bankshavepresented tousinrecent years. Thereport accurately identitk apersistent
 problem.


Aldtou@the wide variancein the contributionofOPOstotissuemoovosyiS- kingfeco- by 

those inthefield ofttansphmtatio~ Itis notlikely that comcctionfcurrant inequities will ocmzrasthe


result ofvolunt.asy efforts. Rather, suchcorrections wouldrequire
 thetmpodtbn of well desigaed changes 

in currentprocedures. Unfottunataly,neitherHKSAnorHCFAcouldundertakesuclIa dauntingtask 

wthout substantialincreasesin resources. Evmmonitoringby UNOSwould OIM tidditionalCOSCS. 

Wesincerely hope thatwides@taddistrlbutkmof your perceptive, well-written reportw~ promptsclfi


examination bythose OPOS that havebeenleast effective insuppcdngtissue
 donation,


cordially
 ours 

\ A 

&&

L 

J ne C.Mowe, Exeoutiva Director


CAN ASSOCIATION OF TISSUEBANKS 

EtecudveLJtrector Jeanne C Mowe,1350BeverlyRd.,Suite220-A,MCLUOI, VA22101, Phone:703-827-9S8LFax 703-356”21P8 

! 

C-II

E!maAssociatiOn of 

organPmCuranent 

Orfzanizations 

April 14, 1994


June Gibbs Brown


Inspector General


Department of Health and Human Services


Cohen Bui.ldLng


330 Independence Avenue, S.W.


Room 5250


Washington, D.C. 20201


RE:	 ERAFT Inspection Report “C?rganProcurement 

Tissue Recovery” 

Dear Mrs. Brown:


Dlima L Clark.
 Indiana


Rcbccaj.Davts, Texas 

Prcstdent-uect 

Jaddhdmon,tlthds


nwsurer


WCP-I D. Haid. TImmaiia@Pasr-t%st&nt


J.Albln
 Yokk 

E18qttolrfw?w?or 

organ~zations and


Thank you for the opportunity to respond to the above. I


understand the purpose is to describe and assees the role of organ


procurement organizations (OPOs) in procuring tissue for


transplantation.


I apologize for my significant delayed response.


Executive Summan?: In your background statement it is stated,


“While OPOS see organ procurement as their primary function, to 

the extent that statutory expectations for tissue recovery are not 

met, opportunities for donating and using tissues are not met.” 

From the content in this report it assumes this conclusion was 

drawn from the various survey methods used. Loosely interpreted, 

OPOS do not see tissue donation as a priority, given whatever the 

OPO does in collaboration with tissue recovery, processing and 

distribution? Is that correct? 

How well each OH) performs its role with tissue banks will, in


fact, vary significantly. How this is evaluated and concluded is 

problematic because of a wide variety of confounding issues. A 

few examples are: 

o an a.bsertcts
 OE bkauddrda.for performance expectations


of the OPO and the tissue bank/s


o an absence of tissue bank leadership communication


with OPO leadership and visa versa


o inter-relationships for OPOS and tissue banks 

o	 inter-relationships of tissue banks in the same or 

close service areas 

These examples an not inclusive, but each will create problems in


OPO and tissue bank relationships.


“The OPOS’ commitment to tissue recovery varies widely.” This


statement is as accurate as the detailed obtained in your survey


methods. Your survey data reports 3 OPOS refer all organ donors


f@r tiSSUe recovery and 2 OPOS reported they refer fewer than 20%


of their organ donors for tissuedonation.


Onc Cambridge
Coun.8110GacchoM Roado Sti[c101W6[oF2MCh~h.VA 22042 .703-5-3AOP0 .FU703-5-3”05”8 
Page 2


Mrs. 3rown


For example the 2 OPOS reporting less than 20%:


o Is this before or after the consent process?


0 Who asked for consent?


0 What was the consent process like?


Stiilar, more introspective questions would need to be asked of the same data 

summarized on page ii. 

In the Recommendations section it is reiterated that the statutory 

requirements for oPOs is to “have arrangements to cooperate with tissue banks


for the retrieval of tissues to assure that all useable tissues are obtained


from potential donors.” In addition, having the same expectation of tissue 

banks should assist in this process anti must be a component of the process. 

One way cotmnunication will not bring about the desired change. This is a twoway street. 

If the PHS is to provide general oversight and guidance, theremust first be 

some standards for expectations for OPOS and tissue banks. Those standards 

should be developed in a collaborative manner to create buy in. once 

standards are developed and implemented then a reasonable system for oversight 

would be more effective. 

Find-S “
 : In the analysis beginning on page 8 the report focuses on the per 

cent outcome for tissue donors from organ donors. The report brings to light 

important confounding concerns in adequately evaluating the data, ie the


impact of th’e.consent process, the publicity given to organ donation. Further


aXIalySiS concludes “that OPOS more involved in tissue banking are likely to


put greater effo* into tissue recovery.” The report goes on to comment that


this may be the result of a greater financial interest or an organizational


culture that encourages and supports tissue procurement. While both are


feasible, perhaps the enhanced outcomes in these OPOS has to do with


investment and control over the actions that OPOS have learned over time will


enhance the commitments of the public served and the professionals involved.


P	~ co It is not fruitful to not support the general


recommendations. It is imperative that we track together, keeping our gOalS


focused on the public we each serve.


The PHH should provide some general oversight and guidance for OPOS regardin9 theix arraag-nts with tissue banks and their tissue recovery activity. 

Recoxmlendation #1: The stated perspective tends to be one-eided, focusing 

primarily on what OPOS must do to ‘defend” themselves based on perceived 

expectations. In addition, the questions that may be asked to ascertain 

useful data are not going to get at the real problems. Pull together the


leadership in organ donation and tissue donation and assist them in developing


standards that hold up expectations of performance for each that result in the


outcomee desired.


Rec~ dation #2: The effective dissemination of “what works” will be 

useful. The actual determinants for “what works” is more complex that 

examiningnumbers. Again,there are so many confounding factors to consider. 

A similar approach as noted above could be useful in this process. 

Recommendation #3: It is unclear how you monitor tensions, evaluate the


reality of these and then proactively problem-solve.


!fheHCFA should include an assessment of OPOS’ performance in tissue recovery


as a part of the OPO recertification process.


C-13

Page 3


Mrs. Brown ,.�

It is not unreasonable for OPOS to be held tQ a standard of performance that 

will provide organs and tissues to the public we serve. It is a known fact 

that OPOS have sought measurements of performance in organ donation since the 

late 1980’s. It is much simpler to know what standards you are being held to 

rather than guessing whether you “measure up.” As a result of this need, 

currently, there is a multidisciplinary OPO Performance Standards Task Force 

in place. This is a collaborative effort between U??OS and AOPO. 

The key to developing performance standards is to involve the parties that


will be affected. This creates ownership and a buy in for the outcome/s.


Again, AOPO appreciates the opportunity to respond. AOPO supports the efforts 

of the Inspector General to hold each of us to a high standard, especially in 

our service to the public. This has been and continues to be demonstrated by 

AOPO’S relationship with the Division of Transplantation, under Ms. Braslow8S 

adept leaciership.
AOPO offers its membership and leadership to assist in the


process.


Sincerely, .


Diana Clark


President


cc: Inspector General File 

C-14

APPENDIX D -


ENDNOTES 

1. DHHS, PHS WorkGroup on Organ and Tissue Transplantation, T&sue and OWan 

Transplantation: Assessment Report, July 18, 1991; Staff Memorandum for Senate 

Committee on Labor and Human Resources, September 29, 1992. The exact level of 

tissue donation and transplantation activity is unknown. we have seen estimates range 

as high as 600,000 tissue grafts annually. The PHS report states that “OPOS and tissue 

banks recovered tissues from an estimated 7,500-10,000 donors last year. These 

tissues were used in approximately 250,000 to 300,000 (mostly bone) allografts.” The 

Senate Staff Memorandum reports that “more than 10,000 tissue donors annually 

supply more than 500,000 pieces of tissue for transplantation.” 

2. Other tissues used in transplantation include human heart valves and arteries, skin, 

bone marrow, and corneas. 

3. HHS Office of Inspector General (OIG), T}te llkfribu~ixz oj_ O%ans for

Transplantation: Expectations and Practices, (OEI-01-89-00550), March 1991. 

There are actually 66 Medicare-certified OPOS, including the OPO of Puerto Rico. 

We limited our universe for this study to the 65 OPOS operating in the 50 States and 

the District of Columbia. A further consideration in this decision was the low level of 

organ procurement activity in that OPO, two donors in 1992. (Appendix B describes 

our methodology in more detail.) 

4. Public Health Service Act, Section 371(b)(2)(I), 42 U.S.C. s273. 

5. American Association of Tissue Banks Newsletter, 16 (Ott 1993) 5:10. 

6. 58 Fed. Reg. 65,514, Dec. 14, 1993 (to be codified at 21 CFR Parts 16 and 1270). 

Representative Ron Wyden and Senator Paul Simon have introduced legislation in 

Congress to regulate tissue banking (H.R. 3547, S. 1702). In addition, New York, 

Florida, and California have passed legislation that regulates tissue banking to differing 

degrees. 

7.	 Bear, Stearns & Co., Inc., Investment Research, “Osteotech, Inc.,” December 30, 

1991. 

8. Jeffrey Prottas, “Issues in Tissue Banking,” (unpublished paper, Brandeis 

University), January 1990. 

9. Ibid. 

D-1

10. PHS, ''Draft USPHSGuidelines for Prevention of Transmission ofHIVthrough 

Transplantation of Human Organs and Tissues,’’ March 17, 1993. When finalized, 

these guidelines will update recommendations on organ and tissue transplantation 

published in 1988, 

11. According to data from the Division of Transplantation in HRSA, 1,137 hospitals 

provided at least one organ donor in 1992, out of more than 5,000 hospitals in the 

country. 481 hospitals provided only one donor, and 656 hospitals provided more than 

one donor. 

12. HCFA Form-576, “Organ Procurement Organization (OPO) Request for 

Designation as an OPO under s 1138 of the Social Security Act,” question lV-7. 

13. See, for example, Helen W. Leslie and Scott Bottenfield, “Donation, Banking, and 

Transplantation of Allograft Tissues,” Nursing Clinics of North America 24 (December 

1989): 891-905. 

14. E.U. Conrad, D.M, Strong, K.R. Obermeyer, and M.S. Moogk, “Tissue Donor 

Testing and Recipient Tracking for Hepatitis C,” AATB Information Alert, 3 (April 

1993) 2. 

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