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Transplant Statistics: Annual Report : Appendix F
The Policy Compliance Department (PCD) at UNOS is charged with monitoring member compliance with OPTN/UNOS policies. Compliance activities and tasks are developed in accordance with federal rules, OPTN/UNOS policies, and contractual requirements.
During the term of the current OPTN contract, the PCD will focus on three activities:
When a center lists a liver, heart, or intestine candidate for a transplant, it must submit a justification form. This form documents the severity of the patient's illness and justifies the status at which the patient is listed. Justification forms currently are submitted in electronic versions. [1]
Urgent status listings for liver and heart patients are forwarded to the appropriate Regional Review Board (RRB) for consideration. Liver RRBs review listings for all liver candidates in Status 1, special case exceptions for MELD/PELD liver candidates, and hepatocellular carcinoma (HCC) candidates. Thoracic RRBs review listings for heart candidates in Status 1A and special case heart candidates in Status 1B. These boards also consider appeals of cases initially turned down for a particular medical urgency status.
RRB reviews and appeals for heart Status 1A and 1B are conducted via facsimile. RRB reviews and appeals for liver Status 1 and MELD/PELD are conducted electronically through UNetsm.
With the implementation of MELD/PELD in February 2002, the RRB began reviewing cases requesting additional MELD/PELD points for special case exceptions. The RRB retroactively reviews all cases requesting additional MELD/PELD points for cases involving hepatocellular carcinoma (HCC). For cases involving hepatopulmonary syndrome, familial amyloidosis, and primary oxaluria, RRB review is prospective. Pediatric patients with metabolic diseases (i.e., Crigler-Najjar Disease Type I or OTC) or nonmetastatic hepatoblastoma require retrospective review for Status 1 and prospective review for requests of additional PELD points.
For all prospective reviews, the RRB has 21 days after a center has requested additional MELD/PELD points for this type of patient to determine a majority vote. If a majority vote decision has not been determined within 21 days, the patient's MELD/PELD score defaults to the original score requested by the center. These cases are referred to the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee and the Membership and Professional Standards Committee (MPSC) for further review.
Since September 2002, all required data fields on the justification form must be submitted online through UNet before patients can be added, upgraded, or extended. Moreover, under this system patients are automatically downgraded unless they are relisted by an attending physician within the time frames described in the definitions of current OPTN/UNOS policy. PCD staff call each center prior to a patient's expected date of justification form submission to remind the center that the form is due and that the patient will be downgraded unless the form is submitted.
PCD auditors verify, during on-site reviews, Status 1A heart listings, Status 1 liver listings, MELD/PELD HCC and special case exceptions, MELD/PELD scores greater than or equal to 20, and the MELD/PELD score at the time a transplant offer is made.
Pursuant to new OPTN/UNOS policy, each transplant center, OPO, and histocompatibility laboratory must complete and submit 95% of expected forms within three months of the due date, and 100% of expected forms within one year of the due date. These standards apply to all data collected on forms and donor referral information submitted to the OPTN. One hundred percent of the potential transplant recipient (PTR) refusal code data must be submitted within 30 days of a match run date.
In order to facilitate the implementation of the new data submission standards, the Board of Directors approved an amnesty plan at its June 2002 meeting. Under the plan, all Transplant Recipient Follow-up (TRF) Forms, except for the one-year, three-year, death/graft failure, or most recently expected follow-up form, generated before June 30, 2002[2], were granted a "forgiven" status in UNet - meaning that the submission of these forms would not be monitored for compliance. All other forms, generated before June 30, 2002, are given a one-year submission deadline of June 30, 2003.
Pursuant to the Amnesty Plan, the PCD is monitoring the OPTN members with outstanding forms for submission of forms by the June 30, 2003 deadline. All members with outstanding forms have received status letters with a detailed list outlining the current outstanding forms. PCD will send letters after six and nine months informing outstanding members of their status. After the June 30, 2003 deadline, members with outstanding forms will be referred to the MPSC for review.
Outstanding Forms Reports are still prepared monthly for primary data coordinators and bimonthly for program administrators and directors, histocompatibility lab directors and OPO executive directors. The report provides summary information on the number of forms overdue by 1-3 months, 4-6 months, 7-9 months, 10-12 months, and more than 12 months. The report also includes information on compliance with data submission policies so that members receive information on the specific forms that are outstanding for their facility, as well as an indication of how they are meeting the policy standards.
In addition to the Outstanding Forms Report, members are contacted when their forms are overdue by at least three months. Institutions with forms that are more than six months overdue are referred to the PCD for further action. The data subcommittee of the MPSC reviews PTR forms submission data and may determine that a letter be sent to the OPOs that have not submitted 100% of their expected PTR forms and have failed to respond to policy compliance requests.
The PCD is responsible for monitoring the organ allocation process to ensure that policies matching organs with waiting patients are followed. This monitoring includes:
A new internal allocation database has been implemented to track documentation of all cases involving allocation discrepancies. The database also facilitates the monitoring of these cases and provides information as to the status of any case.
The PCD works closely with other departments, such as Clinical Data Systems and the Organ Center, to ensure that possible allocation policy violations are identified. The PCD researches all potential violations and presents blinded case histories to the Policy Compliance Subcommittee of the MPSC for further consideration.
The PCD also monitors any trends or developing issues in allocation policy across regions and among members. Any observed issues or problems are summarized, analyzed, and forwarded for review to the applicable OPTN/UNOS committee for clarification, interpretation, or a policy change.
On-site visits are a key component in evaluating members' compliance with OPTN/UNOS policies. Through the on-site review, staff auditors assess how well transplant center programs and OPOs are adhering to listing and allocation policy. PCD staff offer recommendations for improvement when indicated.
Between October 2000 and September 2003, PCD staff will conduct on-site reviews of every heart and liver transplant program in the U.S. As of July 2002, the PCD had reviewed 36 programs at 27 centers since the beginning of the year and will have reviewed approximately 50 centers by the end of 2002. The auditors will have reviewed the medical records of approximately 939 heart patients and 796 liver patients.
On-site reviews of other organ transplant programs for compliance with Patient Notification requirements are being conducted in conjunction with review of a same center's liver and heart programs.
PCD staff began review of OPOs in February 2002 and has conducted 10 OPO on-site reviews. PCD will review approximately 15 OPOs on-site and 175 donor records by the end of 2002.
Selecting institutions and setting the visit schedule is based on the following factors:
A tentative schedule of site visits for each year of the current OPTN contract is reviewed by the MPSC and approved. The schedule is adjusted as needed, based on the factors listed above, or to accommodate other meetings and staff activity in a given region of the country.
Site visits for both program centers and OPOs begin with an in-house review of the organization's compliance rate for forms submission deadlines, followed by an on-site review of medical records or donor records, and an interview with the program coordinator or other program personnel.
All liver and heart transplant programs and OPOs are visited at least once every three years. Institutions may be visited more frequently if circumstances warrant. For transplant programs, the focus of these visits is to verify medical records for compliance with listing criteria, medical urgency status justification, and other OPTN/UNOS policies. For OPOs, the focus is to verify compliance with OPTN/UNOS policies and donor records.
For every on-site audit, a standard report is prepared covering the following:
Reports are completed within three to four weeks of a site visit.
A letter sent with the report includes an executive summary of findings and recommendations and a date by which a response from the center is expected. The response allows the member to comment on the review process and submit any information it had agreed to provide.
Responses, including material that was not available during the audit (e.g., lab test results, nursing notes, donor records) are attached to the report. Issues of noncompliance are presented to the policy compliance subcommittee of the MPSC for further review and disposition. If a response to the report is not received in a timely manner, the PCD sends a letter to the center indicating that the report, its findings, and the center's failure to respond, is being sent to the MPSC.
PCD auditors use a scorecard to assess and summarize the administrative and clinical review of every reviewed program. The clinical score evaluates whether the program can verify all the urgent status listings with the appropriate medical record documentation. The administrative score evaluates the center's performance with the following five factors: prompt removal of patient from urgent status listing after transplant or death, missing justification forms, availability of requested medical records on-site, submission of late justification forms, and errors on justification forms.
The scorecard provides a snapshot view of each center's compliance performance, which allows for a uniform comparison among centers. Scorecard information is included in the auditors report.
Blinded scorecard information is forwarded to the MPSC on a quarterly basis for its review. Each reviewed program during the quarter is summarized and compared with other reviewed programs. The MPSC may request further information for a particular center based upon the scorecard summary.
Appendix Tables F-1 and F-2 below summarize the scorecard compliance rates by program from October 2000 to October 2001, and October 2001 to July 2002.
| Type of Program | Number of Programs | Average Administrative Score | Average Clinical Score |
|---|---|---|---|
| Liver | 54 | 90% | 99% |
| Heart | 50 | 94% | 99% |
| Type of Program | Number of Programs | Average Administrative Score | Average Clinical Score |
|---|---|---|---|
| Liver | 16 | 91% | 95% |
| Heart | 27 | 91% | 99% |
In addition to reviewing medical records, PCD auditors meet with facility staff upon arrival for a review, usually with the program coordinator. The auditor explains the review process and the approximate amount of time it will take to complete. During the interview, the auditor and program staff will:
For OPO reviews, the auditor reviews issues that are specific to OPOs such as organ packaging supplies and requires a demonstration of organ packaging from the OPO. The auditor also reviews how the OPO conducts public and professional education and how the OPO addresses multicultural issues within their respective regions.
Kidney programs are different from liver and heart programs in that kidney allocation is determined, in part, by the amount of time the patient has been waiting, not the severity of the patient's illness.
The PCD is currently working with the OPTN/UNOS Kidney/Pancreas Transplantation Committee on various proposals to conduct renal audits.
For example, staff have been verifying patients' dialysis status, with patient forms, to determine whether kidney programs are providing accurate information. Research staff have been crosschecking patients' dialysis status with the patients' information entered on the waiting list and information submitted on the Transplant Candidate Registration (TCR) and Transplant Recipient Registration (TRR) Forms. The TRR requires the date of dialysis initiation. The TCR is completed at the time of listing, and the TRR is completed at the time of transplant.
The Research staff assessed all the adult patients added to the kidney waiting list during the period of August 1, 2000 to July 31, 2001. During that period, 21,984 adult patients were listed on the kidney waitlist and 18,036 patients indicated they were on dialysis at the time of listing. The patients' dialysis statuses were verified with the information entered on the waiting list and with the TCR and TRR Forms. The staff found that 96% of the kidney programs submitted accurate information regarding a patient's dialysis status. The other 4% may require an on-site review. This type of internal audit and analysis indicates which programs may potentially require on-site reviews.At present, the staff are continuing to summarize and analyze data, such as the analysis of patients on dialysis, for the prospective of conducting on-site renal audits.
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