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Candidate Review Process
Review ProcedurePotential transplant candidates much be reviewed by the respective organ-specific Patient Selection Committee. Each Patient Selection Committee consists of one representative from each appropriate member hospital, a representative from the Ohio Department of Health, an ethicist or bioethicist, and a lay representative who may be an attorney.
Abdominal Organs, Lungs, Heart-Lungs, and Pediatric Heart ReviewsFor the abdominal organs, lung, heart-lung or pediatric heart candidates, upon hospital approval for transplantation, the hospital representative to the OSOTC organ specific Patient Selection Committee will forward the clinical summary to the Consortium office via fax. The clinical summary must be complete, accurate and neatly typed on the approved form. Only in the case of an extreme emergency will a handwritten summary be accepted. (An extreme emergency is defined as a program having a status 1 liver patient, or a liver patient with a MELD/PELD score of greater than 24, and no reasonable mechanism for submitting a typed summary.) If a summary is deemed unacceptable due to either illegibility or inadequate information, the Consortium office shall either return the form to the presenting institution for completion or correction prior to distributing it for review or request the missing information and attach it to the summary. The clinical summary is used to verify that the patient meets the statewide patient criteria and must include:
The Consortium office will fax or email the patient clinical summary to the appropriate Patient Selection Committee members and will verify that the fax was received by the designated party through daily review of the fax journal. Should an error be found, the destination of the misdirected summary will be contacted and asked to destroy the faxed document. Each committee representative will respond by phone, fax or email as to whether they agree that the patient being presented meets the statewide selection criteria. The Consortium office will contact committee members, requesting their decision if they have not responded within two working days of receiving the summary . If a committee member has questions concerning a specific candidate, he/she may email or fax the Consortium office the questions which will be faxed to the presenting program for resolution. A conference call with the committee to resolve any questions may be requested by any committee member.
Heart Candidates (non-pediatric) ReviewsFor the adult heart transplant candidates, upon approval for transplantation by the hospital multidisciplinary patient selection committee, the patient’s medical information necessary to confirm that the patient meets the OSOTC uniform selection criteria as specified in the ORC 3701-84-20, Appendix A, is entered into the statewide patient registry, The OHIO Project, by the presenting institution. The program representative on the Heart Patient Selection Committee is responsible for ensuring the accuracy of the data entered into The OHIO Project (TOP or Heart Registry). Once the form is completed and checked, it is saved in the patient registry, housed at the Institute for Health Policy and Health Services Research in Cincinnati, Ohio. Once the patient record is complete, an e-mail is sent to all members of the Heart Patient Selection Committee notifying them that a patient has been submitted for review. Each committee member is expected to review the medical summary within 24 hours, or during the first business day following its posting. Should the primary reviewer not be available, the e-mail notification will be forwarded by that office to his/her alternate reviewer, requesting him/her to review the patient’s medical information. The reviewer has the option of approving the patient, approving the patient with conditions, or disapproving the patient. With all three options, the reviewer may also post a question, open for all reviewers to see, to the referring program. The referring program will answer the question, again posting for all reviewers to observe. Once all members of the committee have voted and there are no outstanding discussion items, the OSOTC office will certify that the review has been completed. An e-mail is then automatically generated notifying the presenting hospital of the outcome, including approval, disapproval or conditions. A simple majority is required for approval. An audit trail will be maintained to verify which records are viewed by which reviewers.
Second ReviewsSecond reviews for a second transplant are not necessary if the patient is being listed within one year of the first transplant unless the transplanted organ is lost to either recurrent disease or non-compliance. However, the Consortium office must be notified at the time the patient is relisted. Information will be requested regarding the reason for relisting and current patient demographics. All patients requiring listing for a second transplant more than one year following the first transplant will require a second review.
Reviews for Third or Subsequent TransplantsProspective reviews will be conducted for any patient being listed for a third or subsequent transplant regardless of when the last review or transplant took place. The summary must contain detailed information regarding why the previous transplants failed and an explanation of why the program feels a subsequent transplant will be successful and what measures will be taken to improve the chance for success. In addition to the review, a conference call may be held for the committee to discuss the case.
Second Reviews for Non-listed CandidatesCandidates who have been previously reviewed by the Urgent Patient Listings Prior to OSOTC ReviewAll patients who are not deemed urgent shall not be listed with UNOS until the review is completed by the OSOTC. Urgent patients are defined as follows:
If the neither of the two subsequent processes are followed, a review will not be conducted risking loss of reimbursement. The patient summary must note that the patient is being urgently listed and specify reasons for urgent listing. During regular work hours: Urgent patients may be listed simultaneously with submitting the patient summary to the Consortium office (or entered in the Heart Registry for heart patients). Evenings, weekends, or holidays: If the patient's condition is deemed urgent the referring hospital may list the patient for transplant on evenings, weekends, or holidays as long as the appropriate paperwork is submitted to the OSOTC office (or entered in the Heart Registry for heart patients) for review during the next business day even if this constitutes a retrospective review. A patient who is listed and delisted over a weekend due to death or deterioration of health such as they are no longer a suitable candidate for transplant should not undergo a full review. However, the completed patient summary shall be sent to the OSOTC office on the next business day.
The Exceptional PatientThe unusual patient who does not completely fulfill the selection criteria may be considered for a transplant. The summary will be prepared as described previously noting the special condition(s) when the patient does not comply with selection standards. The referring program must explain why this patient should be considered as an exception. If the organ specific committee's questions are not satisfied, a conference call will be scheduled and the patient's eligibility determined by a majority vote. Should the exception patient be the first of a new group of patients now considered to be eligible for transplant, either based on data or the natural extension of the current technology, the committee may elect to recommend to the Board of Trustees that the selection criteria be amended to include that group of transplant candidates.
Candidate ApprovalIt is requested that all reviews be completed within 2 business days. Approvals will be issued only when all votes have been submitted. A majority approval is required for the patient to be accepted as a transplant candidate. For patients who have been approved as an appropriate candidate for organ transplant, the Consortium office will fax a letter confirming the Patient Selection Committee's approval to the referring institution. This letter will also document any comments or suggestions raised during the course of review. Additionally, the Consortium office will mail or fax a letter confirming the Patient Selection Committee's approval to the Medicaid Office - Division of Prior Authorization for patients who are Ohio Medicaid recipients or Ohio Medicaid pending.
Appeals ProcessWhen a decision is not acceptable to the referring physician, a conference call with all the members of that particular Patient Selection committee shall be scheduled. If the conference call does not adequately resolve all concerns, the referring physician may appeal the decision to the Executive Committee of the Consortium's Board. No individual shall review a patient as both a member of the Patient Selection Committee and as a member of the Executive Committee. The Executive Committee's decision is binding.
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