Effective May 11, 2022- Interim Changes to Review Policy
Potential transplant candidates must 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. Upon hospital approval for transplantation, a representative of the hospital’s organ-specific pre-transplantation department will submit the clinical summary to the Consortium by uploading the clinical summary to the OSOTC secure online review system.
The clinical summary must be typed, accurate, and submitted on the approved form as a MS Word document (the approved forms can be found under OSOTC Forms). If a summary is deemed unacceptable due to inadequate information, the Consortium office shall notify the presenting center of the problem, remove the inadequate submission from system, and wait for the clinical summary to be resubmitted by the presenting institution. The clinical summary is used to verify that the patient meets the statewide patient criteria and must include:
- Adequate medical history
- Complete lab data as designated on the form
- Liver programs: A thorough psychosocial evaluation including the patient’s support system, any psychosocial issues, attitude toward and understanding of transplant, and informed consent as well as a chemical use disorder history, if appropriate.
- If the patient has a BMI >40, the summary will contain a more detailed physical description, including an estimate of the ascites, location of masses and if either hypertension or renal insufficiency is a problem.
- Lung programs: If the patient has a BMI >30 but <35, the summary will contain a more detailed physical description.
When a center submits a clinical summary to the online review system it is considered a pending candidate and can only be viewed by the Consortium and the presenting center. After the clinical summary is submitted as a pending candidate the Consortium will process the document, which consists of entering all pertinent information into the Consortium database, remove identifying information, converting the de-identified patient summary from a Word document to a non-modifiable PDF document, and finally, registering the new PDF document onto the review system where it can be viewed by the voting representatives.
Reviewers have the option of unconditionally approving, conditionally approving, or rejecting a patient. With all three options, the reviewer may also post a question to the referring program, open for all reviewers to see. The referring program will answer the question, again posting for all reviewers to view. 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 and post the OSOTC determination letter. The referring program will be notified via email that a determination has been made regarding their candidate. The presenting center can then log on to the online review system to retrieve the OSOTC determination letter. A majority approval is required for the patient to be accepted as a transplant candidate for listing with UNOS.
Each committee representative will receive a daily “reminder to vote” email for all pending candidates for whom they have not yet voted. It is requested that the committee representatives review the clinical summary within 48 business hours following registration. The Consortium office will contact committee members, requesting their decision if they have not responded after 72 business hours of registration.
Should the primary reviewer not be available, the email notification should be forwarded by the primary reviewer’s office to his/her alternate reviewer, requesting him/her to review the patient’s medical information. The primary reviewer’s office should notify the OSOTC office of the absence as soon as possible so that voting rights can be granted to the alternate reviewer during the primary reviewer’s absence.
Second 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.
Candidates who have been previously reviewed by the OSOTC but were never listed, a second (or subsequent) review will be required if more than six months have elapsed since their review. Candidates who were previously listed but removed from the waiting list due to reasons other than having been transplanted, a second (or subsequent) review will be required regardless of how much time has lapse since their previous review.
Prospective 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.
All 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:
- Heart: status 1, 2 or deemed appropriate by the Medical Director
- Liver: status 1 or a MELD/PELD score of equal to or greater than 22
- Lung: calculated LAS score of equal to or greater than 50 or children under the age of 12 with Priority 1 status. A lung candidate with a calculated LAS score of less than 50 may be reviewed as medically urgent, on a case-by-case basis, and should include a statement of medical urgency within the medical summary submitted for review.
The OSOTC online review system is accessible 24/7; urgent patients should be submitted to the OSOTC online review system simultaneously with UNOS listing. The patient summary must note that the patient is being urgently listed and specify reasons for urgent listing. Patients with a diagnosis of substance use disorder should meet the OSOTC Chemical Disorder Criteria prior to urgent listing or undergo concurrent review by the CD Committee and the Organ Specific Committee. All patients shall be reviewed prospectively by the OSOTC organ-specific committee. A patient who is listed and transplanted prior to the completion of the OSOTC review, may not receive an approval letter and risk loss of reimbursement. A patient who is listed and delisted (for any reason) without having been submitted to the OSOTC will not undergo review, however, the completed patient summary shall be sent to the OSOTC office to keep on file.
The 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.
It is requested that all reviews be completed within 48 business hours of registration. A majority approval is required for the patient to be accepted as a transplant candidate for listing with UNOS. 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 and upload the OSOTC determination letter to the online review system. The OSOTC determination letter will also document any comments or suggestions raised during the course of review. The presenting center will then be notified via email that a determination has been made regarding their candidate and can then log on to the online review system to retrieve the OSOTC determination letter. Additionally, the Consortium office will email a determination letter to Ohio Medicaid, Division of Prior Authorization, for patients who are Ohio Medicaid recipients or Ohio Medicaid pending. OSOTC approval expires six months from the letter approval date if patient is not listed with UNOS within that six month period. Should approval expire prior to UNOS listing, a new review is required.
When 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.
The system housing the secure online review system has 256-bit SSL security encryption and complies with all HIPAA requirements. The system runs on three USA-based geographically dispersed, mirrored data centers with built-in replication, disaster recovery, a redundant network backbone, and no single point of failure. The system performs two remote backups per day.
No identifying information is sent through the e-mail system to the reviewers with the exception of the patient’s review number, which is automatically generated by the system, and the link to the patient’s information is inaccessible without entering the online review system with a correct password.
Electronic records will be maintained on a networked PC in the OSOTC office. Each PC will have a network password as well as a screen saver password to ensure the confidentiality of patient records. The OSOTC office also utilizes two-factor authentication for granting remote access to systems that contain Electronic Protected Health Information (EPHI). No patient records shall be removed from the OSOTC office. The OSOTC office will be locked unless at least one person is on the premises. Visitors to the OSOTC office will not be left unattended so as to restrict access to patient records. Paper records shall be scanned and retained indefinitely by the OSOTC office. After scanning, paper records shall be disposed of by secure document shredding.