Department  of  Health  and Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
ORGAN  PROCUREMENT  ORGANIZATIONS

AND  TISSUE  RECOVERY

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,J  ~  JUNE  GIBBS  BROWN 
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2  MAY  1994 
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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  OIGS 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  OIGS 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 
Foradditionalcopiesof thisrepq  pleasecontacttheBostonregionalojjice 
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$ 
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GIBBS  BROWN 
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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  musculo
skeletal  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 opportunitze.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. 
I  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  reported more than 150 tissue donors  for  eve~  100  o?gcm 
OPC)S 
donors.  At  the other extreme, 3 OPOS procured  tissue from  fewer  than  20 tissue 
donom for  evety 100 organ donors. 
ii  Temons &t  between o~an  procurement  and tiwue recovery.  If these temons 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  mtten  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  OPOS  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 femble  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 
INTRODUCIION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...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  musculo
skeletal  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  nations  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 
individuals  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  nations  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  Presidents  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  OPOS  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  OPOS  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  one-
stop  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  OPOS  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 donahon. 
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  I 
21%-30V0  7  II
, 
II  I 
31%-40%  5 
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  donors  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 01OS  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 
I 
fewer  than  50  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  donors  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  havent  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  OPOS  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 
wtten  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  OPOS  donor  hotline  for  tissue  referrals  within  the  OPO  service 
area.  This  single  number  is included  in each  tissue  banks  hospital  development 
12
 materials,  as  well  as  the  OPOS  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  OPOS  or  tissue  banks  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  nations 
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  OPOS  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  OPOs  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  donors  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  donors  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  donors  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 
donors  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  donors  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  donors  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  nations  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 Vikts 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. 
RevIewof 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 
Memorandum 
+
%+%V!~( 
./@ll 201994 
Date 
From  Assistant  Secreta~  for  Health 
organ  Procurement 
Office  of  Inspector  General  Draft  Report 
Subject  OEI-01-91-00250 
Organizations  and  Tissue  Recoveg~ 
To  Inspector  General,  OS 
on  the 
Attached  are  the  Public  Health  Senice  (PHS) comments

Though  we  agree  with  the  recommendation

subject  draft  report. 
directed  to  PHS,  we  note  that  to  undertake.tpe  StePS
requ~re  additional
 programmatic

encouraged  in  the  report  would 
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.MlnistratlOnS 
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  .,,..?.., 
-.+  ) 
JigDEPART.ll ENT OF HEALTH  & ~UNIA&  SERIlCES  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  studys  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  OIGS  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  reports  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  Administrations  (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  studys  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  OIGS  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 
# 
Wastrlngton.  13.C.  20201 
- .,+=;j~ 
20:
 June Gibbs Brown 
Inspector  General 
FROM:	 Assistant  Secretary  for 
Planning  and Evaluation 
llorgan 
procurement  organizations
SUBJECT:  OIG Draft Report, 
(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
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February  3,  1994 
June Gibbs  Brown

Inspector  General

Department  of Health  & Human  Services

Office of Inspector  Generai

Washington,  D.C.  20201

Re:	 Draft  Report  on  Organ Procurement  Organizations  and l%sue Recovery  (OEI-
01-91-00250) 
Dear  Ms.  Brown: 
Thank  you  for providing  us  with  the  opportunity  to comment  on the Office  of Inspector 
Generals  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 
corporationthatoperatestheNational  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 reports 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  reports  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 reports recommendation,  there currently 
are  no  funds  available  for  this  task  under  the  OPTN  contrac~  Also,  UNOS  has  no private 
funding available for  Thereforiem,plementation  of this ~ommendation  WO~d Wfie 
this  task. 
additional  funding  iromtiefederai  governmen~ 
Again,wc appreciate  the opportunity  to comment  on the Office  of Inspector  Generals 
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  CovfMoas 
BOARD  W 
American Association of Tiiue  Banks 
FcbruaIY8,1994

June Gibbs&own

InspectorGcJJera~OffiwoftheInspecforGeneml

Deparunenotf
HeakhandHumanScmica 
330IndependencAev enue,SW

WashingtoDnC,
20201

DearM rsB.r
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lmuk youforafforduisntgheo pportutnoirtcyv kwt hehm~orG~~~  ~  W  ~U~ed0~8~

Pmcwment  Organizationsand T&suRe eccweTYW.rJhavereviewedthereportandofferthefollowrng 
cammenw 
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 pearsto beboththoroughandwellconstructedforitsintended 
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Bankshavepresentteodu sinrecenyte arsT.h ereporatc curateildye ntitakp ersistpernotb
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Aldtou@thewide varianceinthe contributionofOPOstotissuemoovosyiS- kingfeco- by 
thosien thefield ofttansphmtatIitoi~sn otlikeltyh acto mcctioonfc urranitn equitwiielslo cmzrasthe

resulotfv olunt.eafsfyo rtRsa.t hers,u chcorrectiwoonusl drequirteh
etmpodtbn of well desigaed changes 
incurrentprocedures.Unfottunataly,neitherHKSAnorHCFAcouldundertakesuclIadauntingtask 
wthout substantialincreasesin resources. EvmmonitorinbgyUNOSwouldOIM tidditionalCOSCS. 
Wesincerely hopethatwides@taddistrlbutkmof your perceptiwveel,l -writrteepno rwt~ promptsclfi

examinatiboynt hosOeP OSthahta vebeenleasetf fectiivnseu ppcdngtissudeo
nation,

cordialAloyu
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CAN ASSOCIATION OF TISSUEBANKS 
EtecudveLJtrectoJr eannCe  Mowe,1350BeverlyRd.,Suite220-A,MCLUOVI,A22101, Phone:703-827-9S8LFax 703-35621P8 
! 
C-II
 E!ma-
DlimLa ClarkI.n
diana

AssociatiOn  of  Rcbccaj.Davts,  Texas 
Prcstdent-uect 
organPmCuranent 
Orfzanizations  Jaddhdmon,tlthds

nwsurer

WCP-I  D. Haid. T-
Immaiia@Pasr-t%st&nt

J.Albln

Yokk 
E18qttolrfw?w?or 
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  organ~zations  and

Tissue Recovery 
Dear Mrs. Brown:

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.bsertctOsE
 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.

OncCambridgeC
oun.8110GacchoM  Roado Sti[c101W6[oF2MCh~h.VA  22042.703-5-3AOP0  .FU703-5-3058  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 two-
way 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 the.consent process, the publicity  given to organ donation.  Further

aXIalySiSconcludes  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  1980s.  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??OSand 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 
AOPOS relationship  with the Division of Transplantation,  under Ms.  Braslow8S 
adeptleaciership.A
OPO 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~ioxjz_O %ansfor
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. 
D-2