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Transplant Statistics: Annual Report
APPENDIX G
OPTN Policy Compliance Activities as of July 2001
The Policy Compliance Department (PCD) at UNOS is charged with monitoring member compliance with OPTN policies. Compliance activities and tasks are developed in accordance with Federal rules and OPTN policies and contractual requirements.
The work of the PCD has grown markedly over the last year. As a result, the size of the department has increased tremendously, from approximately four staff in 1999 to 22 in 2001.
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, they 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. When justification forms are received, the PCD processes them, ensures that they are complete, and makes an initial determination as to whether or not the patient meets the listing criteria. Urgent status forms for liver and heart are forwarded to the appropriate regional review board for consideration.
The regional review boards review forms for heart candidates in medical urgency status 1A and, in some cases, 1B, and for liver candidates in status 1, 2A, and, in some cases, 2B. These boards also consider appeals of cases initially turned down for a particular medical urgency status.
Justification forms should be submitted within 24 hours of listing or a change in status of a patient on an organ-specific waiting list. Staff in the PCD checks each day to see who has been listed. If a justification form is not received within 24 hours, the PCD calls the listing center's program coordinator. If the form still is not received, staff sends a certified letter to the program coordinator. If these efforts fail to produce the justification form, the matter is referred to the policies compliance subcommittee of the MPSC. Patients are not removed from, or downgraded on, the waiting list for lack of a justification form.
PCD staff processes approximately 1,000 liver and 500 heart forms per month.
Pursuant to UNOS policy, each transplant center, OPO, and histocompatibility laboratory must complete and submit 95% of expected forms within 6 months of the due date, and 99% of expected forms within 1 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. Member data submission policies currently are out for public comment and may change such that 95% of expected forms are received within 3 months and 100% of expected forms are received within 6 months of the due date.
An Outstanding Forms Report is prepared monthly for primary data coordinators and bi-monthly 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 greater 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 well overall they are meeting the policy standards.
In addition to the Outstanding Forms Report, UNOS staff contacts members when their forms are overdue by at least 3 months. Institutions with forms that are more than 6 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 requests from UNOS staff.
In January 2001, the data subcommittee reviewed a new PTR report prepared by UNOS staff. The report showed that approximately 50% of PTR forms were actually submitted and completed within 15 days, as per UNOS policy. The subcommittee expressed concern that OPOs were adhering to the policy only half of the time, and they asked the OPO Committee to study this issue further to determine the reasons why PTR forms are not regularly submitted on time. These reviews subsequently resulted in a recommendation that the policy be modified to allow OPOs additional time to complete the record. This proposal was distributed for public comment in August 2001 and has not yet been finalized.
The PCD is responsible for monitoring the organ allocation process to ensure that policies matching organs with waiting patients are followed. This monitoring includes:
The PCD works closely with other UNOS 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.
While some policy violations are clear-cut, for example, if a match list was ignored, other issues require independent medical review by peer physicians or surgeons. In these cases, the regional review boards ensure that policies are fairly and consistently applied with accepted medical practices. Programs that wish to appeal decisions by a regional review board are referred to the organ-specific committees, and then possibly to the MPSC. By the time a case is referred to the MPSC, more than a dozen medical professionals have reviewed it. Regional review boards communicate to the PCD the decision for every appeal so that staff will become better informed as they review cases and issues.
On-site visits are a key component in evaluating a transplant program’s compliance with OPTN policies. Through the on-site visit, staff auditors assess how well programs are adhering to allocation policy and 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 and OPO in the U.S. Selecting institutions and setting the visit schedule is based on the following factors:
A tentative schedule of site visits for the 3 years of the current OPTN contract has been reviewed by the MPSC; it will be adjusted as needed, based on the factors listed above, or to accommodate other meetings and staff activity in a given region of the country. Currently, the PCD plans to visit 105 centers in 2001, including 88 liver and 87 heart programs. It is expected that approximately 2,200 liver and 1,900 heart patient charts will be reviewed during these visits. On-site audits for all other organ types are not being conducted at this time.
Site visits 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 and an interview with the program coordinator or other program personnel.
Before visiting a member institution, PCD staff completes a review of all forms submitted by the member.
Three weeks prior to a site visit. Approximately 3 weeks prior to a site visit, a PCD auditor:
Two weeks prior to a site visit. Approximately 2 weeks prior to a site visit, the auditor:
Three days prior to a site visit. Approximately 3 days prior to a site visit, the auditor:
All liver and heart transplant programs and OPOs are visited at least once every 3 years. Institutions may be visited more frequently if circumstances warrant. The focus of these visits is on reviewing medical records to determine compliance with listing criteria, medical urgency status justification, and other OPTN policies. For every on-site audit, a standard report is prepared covering the following:
Reports are completed within 3 to 4 weeks of a site visit. A letter sent with the report includes an executive summary of findings and recommendations, indicating a date by which a response from the center is expected. The letter allows the program to comment on the review process and add any information it had agreed to provide.
Responses, including material that was not available during the audit (e.g., lab test results, nursing notes) 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.
In addition to the regularly scheduled on-site visits for liver and heart programs, PCD staff also audits members for violations of policy or by special request by the Secretary of HHS. Table G-1 below shows the number of site visits and chart reviews performed in 2000.
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:
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. While programs must be able to verify the information submitted on forms, and any supporting documentation is subject to a site review by PCD staff, there have been no on-site reviews of kidney or kidney-pancreas programs. At present, the Kidney/Pancreas Transplantation Committee is reviewing information on auditing these member institutions. It is likely that most audit information can be obtained via written inquiries and documentation rather than through on-site visits.
The MPSC is currently considering possible approaches to auditing OPOs and histocompatibility labs. Again, information is available through written requests and may not require on-site visits.
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