November 29,2005

Grassley seeks information on HRSA’s ability to detect and prevent fraudulent and improper allocation of organs

November 29 2005

Elizabeth M. Duke, Ph.D
Health Resources and Services Administration
Parklawn Building
5600 Fishers Lane
Rockville, MD 20857

Dear Administrator Duke:

As Chairman of the Senate Committee on Finance (Committee), I would like tothank you for your prompt and thorough response to my October 19, 2005 letterrequesting information on how the United Network for Organ Sharing (UNOS) handlesallegations of “line jumping” and other violations of policies developed by UNOSpursuant to its contract with the Health Resources and Services Administration (HRSA)to administer the Organ Procurement and Transplantation Network (OPTN). Theinformation you provided reassures me that violations of UNOS allocation policies, particularly “line jumping,” are uncommon. Nonetheless, I have some remainingconcerns about the ability of HRSA and UNOS to detect and prevent fraudulent and/orimproper allocation of organs. In addition, I recently learned about serious problems atanother transplant center, the University of California Irvine Medical Center (UCI) thatmake me wonder whether HRSA and UNOS are acting in the best interest of transplantcandidates. I will discuss my concerns relating to St. Vincent and organ allocation andthose relating to UCI separately.

Concerns relating to St. Vincent Hospital:

First, it is not clear that UNOS’s June 15, 2005 audit of St. Vincent identifiedsignificant problems with the September 8, 2003 transplant that was later found toinvolve violations of OPTN policies. The audit report on St. Vincent does not indicatethat UNOS had any concerns about possible violations of UNOS liver allocation policiesor that it had any concerns about the September 8, 2003 transplant. The only findingrelating to the September 8, 2003 transplant was a finding that St. Vincent had notremoved two of 35 transplant candidates sampled, including the patient transplanted onSeptember 8, 2003, from the OPTN liver waiting list immediately as required by OPTNpolicy. According to a supplementary timeline provided with the audit, UNOS did notbecome aware that St. Vincent transplanted a liver into a patient other than the designatedrecipient until September 20, 2005 when St. Vincent’s liver program administratornotified UNOS that it was investigating the matter.

Second, I am concerned that the September 8, 2003 transplant did not trigger anyinvestigation at the time of the actual transplant. The timeline submitted with the auditindicated that St. Vincent originally removed patient number 52, the actual transplantrecipient, from the OPTN liver waiting list on September 9, the day after the transplantbut subsequently asked UNOS to re-list the patient because he had been removed in error.

According to the audit report, it was not until September 16, eight days after thetransplant that St. Vincent removed patient number 2 from the waiting list. The OPTNEvaluation Plan you provided indicates that UNOS reviews daily all deceased donor livermatch runs to determine if the organs were allocated according to the match run sequenceand examines all instances where the match run was not followed to determine if theallocation was a violation of policy. Although St. Vincent subsequently re-listed patientnumber 52, given that there was a delay in de-listing the intended recipient, I wouldexpect that the initial report that patient 52 had been transplanted would be cause forsome further investigation.

Third, although I did not specifically request information regarding the relativelyhigh rate of livers transplanted to foreign nationals at St. Vincent, I am concerned thatthis was not addressed in the June 15, 2005 audit of St. Vincent and HRSA did notaddress it in its response. According to newspaper accounts, approximately eight percentof the livers transplanted at St. Vincent went to foreign nationals. UNOS policyregarding transplantation of non-resident aliens states that “at centers where non-residenttransplant recipients constitute more than 5 percent of recipients of any particular organtype, circumstances underlying the transplants for non-resident aliens will be reviewed bythe [UNOS Ad Hoc International Relations Committee].” I would like to know if theUNOS Ad Hoc International Committee has reviewed liver transplants to non-residentaliens at St. Vincent and what it has found.

Concerns Related to the UCI Transplant Center:

Recent news reports described serious problems with UCI’s transplant programthat started more than three years ago. UCI’s liver transplant program turned down amajority of liver offers received from the regional Organ Procurement Organization(OPO), most of which were accepted by other transplant centers. UCI’s organacceptance rate, 4 percent, was less than half the usual rate for the region and fromAugust 2004 to July 2005, UCI rejected more than 100 of the 122 liver offers it received.Although UCI claimed that it refused most of the organs because they were of poorquality, it appears that the real reason may have been a lack of capacity to performtransplants due to personnel problems.

According to news reports, UCI has been operating for more than a year, sinceJuly 2004, without a full-time transplant surgeon. The former head of the transplantcenter, who left UCI in July 2004, reportedly alienated other transplant surgeons hired byUCI and was apparently focused more on building a practice involving other types ofliver surgery than on performing transplants. As a result, for the last three years UCIfailed to perform the minimum number of annual transplants, 12, required to maintainactive status. We need to know whether these factors contributed to the high organrefusal rate at UCI and also had an impact on patient outcomes – the percentage oftransplant recipients at UCI who survived at least a year was well below the survival raterequired for Federal certification.

It appears that patients almost certainly died, whether because an organ that couldhave been transplanted was refused, or because the transplant team was out of practicedue to the low volume of transplants. Yet UCI was still aggressively recruiting newpatients for its transplant center. I want to know if UNOS and/or HRSA did anything toensure that those patients had the same chance to receive a liver transplant as otherpatients on the wait list.

It seems to me that UNOS, and by extension HRSA, should have been aware of atleast some of these violations. The number of organ refusals was reported by the regionalOPO and UNOS itself conducted an audit of UCI in 2003 and again in June 2005.Nonetheless, according to the information you provided in response to my last letter, thismatter is still under review and no action has yet been taken against UCI. In addition,UNOS reaccredited UCI’s transplant program in December 2004. I wonder how manyother transplant programs are needlessly rejecting organs without the knowledge ofpatients desperately awaiting a transplant.

Other Concerns:

I am concerned that UNOS is not taking adequate corrective action when itdetermines that a UNOS member violates OPTN policy. In response to our request forinformation on allegations received and investigated by UNOS in the last 5 years, yousubmitted information on 24 allegations from 2003 through 2005. No information wassubmitted for 2000 through 2002. It appears that resolution of three of these allegationsinvolved continuous monitoring, which is still ongoing. I would like to know what thismonitoring entails and how UNOS ensures that transplant candidates at monitoredcenters are safely and fairly treated. In addition, according to the information provided,UNOS found that two OPOs violated OPTN Policy 3.3.6, Center Acceptance of OrganOffers. One of these OPOs was informed of the decision and it was indicated that theother OPO would be notified that the issue had been taken under consideration. I don’tunderstand how informing an OPO that it has violated policy prevents such a violationfrom occurring again.

You also submitted information on facilities that had been considered for“member not in good standing” status. In response to our request for information on allmembers that UNOS has considered for “member not in good standing” status since1986, you submitted information on 17 members, including seven OPOs and 10transplant programs that had been recommended for “member not in good standing”status by the Membership Professional Standards Committee (MPSC) from 2002 through2005. You did not submit information on recommendations for “member not in goodstanding” status prior to 2002. Although you report that most of these members satisfiedthe MPSC’s concerns, you reported that one member transplant center was still onprobation and a second center had until October 31, 2005 to provide information relatingto its compliance with OPTN bylaws. For all members recommended for “member not ingood standing” status, but particularly for the two members mentioned above, I amconcerned that potential transplant recipients did not know of potential problems withthese centers.

Finally, I am concerned that HRSA may not be playing an active role inoverseeing the OPTN contract with UNOS. UNOS is required to report to HRSA theresults of any reviews and evaluations which indicate noncompliance with applicableFederal regulations or OPTN policies or indicate a risk to the health of patients.

Although my initial request for information was directed to HRSA, there is no evidencein the information provided of HRSA’s role in evaluating potential instances of noncomplianceidentified by UNOS. In addition, I am concerned that only if a policy isdesignated by HRSA as mandatory, does UNOS have authority to suspend memberprivileges for violation of the policy, yet HRSA did not designate a single UNOS policyas mandatory.

Accordingly, I am requesting that HRSA arrange to brief my staff on its role inoverseeing the OPTN contract, specifically its role in evaluating allegations againstUNOS members and possible instances of non-compliance with UNOS policies orFederal regulations. In addition, please provide following additional information by nolater than December 12, 2005:

1. Please indicate whether UNOS was aware of any possible impropriety at St.Vincent with respect to the September 8, 2003 liver transplant of patientnumber 52 on the match list prior to September 20, 2005 when the liverprogram administrator at St. Vincent notified UNOS that falsified recordsrelating to this transplant had been intentionally submitted to UNOSbeginning in 2003 and continuing to the present.

2. Please describe any actions UNOS took to investigate St. Vincent’s initiallisting of patient 52 and/or the subsequent de-listing of patient number 2, theintended recipient, immediately subsequent to the transplant. In addition,please indicate how frequently de-listing errors are reported to UNOS (e.g.,how many times each year) and UNOS’s usual procedure for investigatingsuch an incident.

3. State whether HRSA or UNOS recently reviewed/plans to review the OrganProcurement Organization (OPO) that serves St. Vincent to determine whetherthe OPO met its responsibility to report inaccuracies or transfers that appearedto be inappropriate to the UNOS regional review board staff?

4. The OPTN evaluation plan that you provided indicates that UNOS generates areport for every meeting of the Ad Hoc International Relations Committee toreview centers that go above the five percent threshold. Please provide:

a. copies of all of these listings from January 1, 2000 through June 30,2005;

b. a list of all centers during that time period that were referred to theMPSC because they either did not provide justification for going overthe five percent threshold, or repeatedly went over the five percentthreshold;

c. a summary of the actions taken by the MPSC for those centers referredto them during this period; and

d. a summary of the actions taken with respect to those facilities referred tothe Ad Hoc International Relations Committee that were not furtherreferred to the MPSC.

5. Please provide a copy of the 2003 UNOS audit of UCI Medical Center’stransplant program and describe any follow-up actions taken by UNOS orHRSA to resolve issues identified in the audit.

6. Please provide a copy of the 2005 UNOS audit of UCI Medical Center’stransplant program.

7. For each transplant center, please provide the following information by yearand by organ type for January 2000 through June 2005:

a. the number of organ offers received;

b. the number of offers accepted;

c. for each refusal please indicate the reason for the refusal and whether theorgan was accepted by another center.

8. Information in your original response indicates that UNOS continues tomonitor several organizations that were either investigated based on anallegation and found to be out of compliance with UNOS policies, or thatwere considered for listing as members not in good standing. Please explainthe monitoring process referred to.

9. Please provide the number of on-site reviews conducted by UNOS eachcalendar year from 2000 through 2005 and approximately how often UNOSperforms an on-site review of each institutional member?

10. Please verify that UNOS did not receive or investigate any allegations incalendar years 2000-2002. If UNOS did receive or investigate any allegationsduring that time period, please provide information on those allegations in thesame format used to provide information on allegations from 2003 through2005.

11. Please verify that the UNOS Membership Professional Standards Committeedid not recommend any members for “member not in good standing” statusprior to 2002. If any members were recommended for “member not in goodstanding” status prior to 2002, please provide information on the evaluation ofthose members in the same format used to provide information on membersevaluated between 1986 and 2005.

12. Please explain why HRSA has not designated any of the OPTN policies asmandatory.

Thank you in advance for having your staff coordinate with my staff about thisletter by December 5, 2005. Responses to questions 1 through 12 should be provided nolater than December 12, 2005. Any questions or concerns should be directed to DiannJohnson, Investigative Auditor or Emilia DiSanto at (202) 224-4515, All formal correspondence should be sent electronically in PDF searchable format to Alloriginal material should be sent via USPS mail. Please do not hesitate to contact me ifyou have any concerns.


Charles E. Grassley

cc: Walter K. Graham
United Network for Organ Sharing