(A) Each provider of an extra-renal, solid organ transplant service shall participate in a prospective, statewide review process for each patient prior to listing for transplant. The prospective review process shall include a separate review committee for each type of organ. Each review committee shall include at least one transplant physician or transplant surgeon from each program that actively participates in transplantation services for the appropriate organ. An affirmative vote of a majority of the members of the review committee is required in order to list a patient.
(B) Each provider of a solid organ transplant service shall adhere to identical patient selection criteria, including:
(1) For kidney patient selection, end stage renal disease defined as dialysis dependence or pre-dialysis deterioration of renal function as manifested by the following:
(a) For adult patients, a creatinine clearance less than thirty milliliters/minute for diabetic patients and less than twenty milliliters/minute for all other patients; or
(b) For pediatric patients over the age of two, evidence of structural or functional kidney abnormalities (abnormal urinalysis, imaging studies, or histology) that persist for at least three months, with or without a decreased glomerular filtration rate (GFR), as defined by a GFR of less than 60 mL/min per 1.73 m2.
(2) For liver, heart, combined heart/lung, pancreas, pancreas islet cell, lung, or small bowel patient selection, the prospective patient selection criteria listed in appendix A to this rule and screening criteria for patients presenting with histories of alcohol or substance dependency as listed in appendix B to this rule.
(3) For heart and lung patient selection, the screening criteria for patients presenting with histories of tobacco use as listed in appendix C to this rule.
(C) If a transplantation service desires to perform a transplant on a patient who does not meet the selection protocols set forth in appendix A to this rule, the facility will need to establish that a thorough review of the case was undertaken to determine that the transplant was appropriate. This review shall, at a minimum, include:
(1) Preparation of a detailed clinical summary of the patient including: a brief medical history, complete laboratory data, a thorough psychological evaluation including the patient's support system, any psychological issues, attitude toward and understanding of the transplant, informed consent, and a justification of the transplant despite failure to meet the selection criteria;
(2) Circulation of the clinical summary to a committee comprised of, at a minimum, the director of health or the director's designee, one experienced transplant physician or transplant surgeon from each organ transplant program who actively participates in transplant services for the appropriate organ, an ethicist or bioethicist, and a lay representative who may be an attorney;
(3) Convening of the committee established in paragraph (C)(2) of this rule to discuss the clinical summary of the patient; and
(4) After sufficient review time, an affirmative vote of a majority of the members of the committee that the transplant is appropriate.
(D) Patients presenting for extra-renal transplantation that have histories of alcohol or substance dependency and do not meet the standard criteria conditions set forth in paragraph (B)(1)(a) or (B)(1)(b) of appendix B to this rule may be evaluated for listing by the chemical disorder committee. The committee shall:
(1) Be comprised of a minimum of one chemical dependency counselor or addiction treatment professional from each organ transplant program in Ohio that actively participates in transplant service. Each member must be appropriately credentialed to diagnose substance use disorders either independently or under the clinical supervision of an individual, who reviews and co-signs the diagnosis, and is appropriately credentialed by:
(a) The Ohio chemical dependency professionals board;
(b) The Ohio counselor, social worker, and marriage and family therapist board with chemical dependency scope of practice; or
(c) Is a physician with certification by the American society of addiction medicine or subspecialty certification in addiction psychiatry from the American board of psychiatry and neurology.
(2) Make an advisory recommendation to the appropriate, organ specific patient selection committee under the prospective statewide review process.
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 5/20/04, 6/1/07, 5/15/08, 6/21/12