3701-84-20 Patient selection.

(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 a creatinine clearance less than thirty milliliters/minute for diabetic patients and less than twenty milliliters/minute for all other patients;

(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, 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 dependency committee, which shall be comprised of a representative from the department of health and a minimum of one chemical dependency counselor from each organ transplant program in Ohio that actively participates in transplant services. Every chemical dependency counselor that participates on the chemical dependency committee must be appropriately credentialed to diagnose chemical dependency conditions either independently or under the clinical supervision of an individual who is appropriately credentialed by the Ohio chemical dependency professionals board, the Ohio counselor, social worker, and marriage and family therapist board, or the American society of addiction medicine to diagnose chemical dependency and who reviews and co-signs the diagnosis. The chemical dependency committee shall make an advisory recommendation to the appropriate, organ specific patient selection committee under the prospective statewide review process.

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Effective: 06/21/2012
R.C. 119.032 review dates: 04/05/2012 and 05/01/2017
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